Dermatologists setting up shop as a clinical trial center may see many benefits, but they also face multiple challenges. As clinical trials expand well beyond academic centers and move increasingly into the community-practice arena, many dermatologists who’ve not performed research are being enticed to give it a try. The primary appeal is the opportunity to expand the dermatologist’s — and the practice staff’s — horizons. And in this era of declining reimbursement, some practices are eyeing the remuneration of research participation as an additional revenue source. Veterans of practice-based research are quick to point out both the upsides and the sometimes considerable downsides of becoming a study site. For Dallas, TX, dermatologist Jennifer Cather, MD, who has spent a decade as a trial investigator, the experience has proved rewarding on several levels. “I have participated in cutting-edge research, provided new treatment modalities to my patients, and I’ve also had the opportunity to interact with other key investigators, scientists and industry leaders around the world,” says Dr. Cather, who has participated in and also designed several psoriasis clinical trials. “It is a great learning experience for my whole staff, and it also really helps to build our team.”
Experts’ Tips
It’s impossible to steer clear of all of the pitfalls of clinical trial research, but dermatologists can at least reduce their risk and improve their chances of success by employing diligence and forethought. Following are tips offered by sources interviewed for this article: Review the study and the product thoroughly before becoming an investigator. “Prospective investigators must scrupulously look over the content and design of the study and the entirety of the package to make sure they aren’t potentially getting involved in something that could end up blowing up in their faces.” ~ Dr. Schlessinger “Do not do a study that you feel is not safe for patients. I have turned down a filler trial when I felt the filler was not a good product.” ~ Dr. Baumann Understand the time commitment. “A crucial issue in doing a trial is understanding that the protocols take an enormous amount of effort on the part of the staff. In fact, 95% of the work of a protocol may be done behind the scene y a staff member, and only 5% by the physician.” ~ Dr. Gelfand Do negotiate the budget, particularly line items like recruitment and investigator meeting attendance. All sources recommended asking for at least minor adjustments to the budget if it seems inadequate, but noted that negotiating can be difficult. “I have found companies to be very fair, but we [our center] do have an a la carte type menu of prices — for a photo, a blood draw, a telephone visit, PI visit or injection, for example.” ~ Dr. Baumann Start with a later-phase study. All sources recommended incremental involvement, starting with Phase III or IV studies, when the drug or device has already undergone the initial safety and efficacy review. Understand the ethical issues. “As a physician, you have a lot of influence over patient decision making. You hand the patient this complicated 10-page form and the patient says, ‘What should I do, doc?’ So there’s an inherent conflict between a researcher and a clinician — as a researcher you have an obligation to research, and as a clinician you have a full obligation to the patient.” ~ Dr. Gelfand Be prepared to recruit well outside the practice. “We sometimes have a hard time recruiting patients from our practice because they come to you expecting to be treated. And if you steer them toward a trial that may be placebo-controlled that’s not the ultimate reason they came to you in some circumstances.” ~ Ms. Clark Take informed consent and staff oversight very seriously. “During the course of a trial, the consent form may go through several amendments. And if you consent the patient with the wrong version of the consent form, according to the FDA, you have not consented that patient.” ~ Dr. Gelfand
The intellectual rigor and altruistic aspects of clinical trial participation — not to mention the additional revenue — may be appealing, Dr. Cather observes. But dermatologists who’ve not been principal investigators (PIs) need to understand the requirements and the risks, financial and logistical, before taking the leap. “Serving as a study site is ultimately a business decision. As a PI it’s important to understand the overall cost implications of conducting the trial,” she explains. Those implications are numerous. Not only must the prospective PI “staff up” and make adjustments to the physical space to accommodate the research, but dermatologists must also understand that research participation is a time-consuming business. Patient recruitment, pre-screening and consent activities might require relatively minimal dermatologist involvement, but the time expenditure for staff can be enormous, longtime PI Joel Schlessinger, MD, of Omaha, NE, contends. And the up-front activities of becoming a trial site are far more demanding, for all involved, than many dermatologists realize. For example, a site-initiation visit can take from 30 minutes to several hours, and dermatologists who serve as PIs, as well as study coordinators, may be required to attend weekend-long investigator meetings. And if the site gets audited by the FDA, staff could spend many hours preparing for and dealing with that event. “There are challenges for the practice, in having the physician and staff away from the office for 1 to 3 days to ‘learn’ the study. And while research can be well compensated, the practice can actually lose money on a given trial,” Dr. Schlessinger explains, for a host of reasons. The trial may not be well enough reimbursed to provide adequate revenue, because of an onerous protocol, unexpected recruiting difficulties, or even poor study design, among other factors. “There are a lot of startups in the industry with little money to provide for the actual research,” he says, and it’s hard for novices to know beforehand whether the compensation will be adequate. In addition, because of market conditions — namely increasing competition, especially in cosmetic-treatment trials — many studies these days are reimbursing less than they used to, notes Dr. Schlessinger, president emeritus of the American Society of Cosmetic Dermatology and Aesthetic Surgery. “There are a lot of ifs, and even a study that would seem to be a slam dunk — like a simple acne study — has many potential pitfalls and may be difficult to recruit for, given the necessary criteria for the study,” Dr. Schlessinger says. Some lesser known pitfalls in that regard include: • Inordinately extensive inclusion or exclusion criteria, making it hard to identify suitable patients. • Inadequate budget, given the patient testing, monitoring and visit requirements. • Trial timing, which may translate into difficulty recruiting teens, for example, because they’re too busy with school to come into the practice for screening. • A protocol that requires a laboratory collection that’s painful — or tests that are particularly burdensome. • Failure to understand the potentially significant time commitments for the investigator and the staff, which could make it not worthwhile to participate. “It’s really hard to know some of this up front,” Dr. Schlessinger says. “No study comes with an explanatory document that says, ‘Here’s why it would or would not work.’ Clearly there are cues, but it’s challenging for the novice to know whether they’re getting a good study or a dud.” And unfortunately, even the sponsoring company’s track record might not be an indicator of whether the study will be a “winner,” Dr. Schlessinger and other sources concur.
Tally the Prerequisites; Understand the Risks
The downsides needn’t deter dermatologists from setting up shop as a trial site. But the better informed they become about research activities in general — and site space and staffing needs, in particular — the better their chance of making the enterprise a gratifying one. Joel Gelfand, MD, MSCE, medical director of the University of Pennsylvania’s Clinical Studies Unit and assistant professor of dermatology and epidemiology, urges prospective researchers to steep themselves in the big picture and the minutia before proceeding. “Dermatologists need to know a lot before they get involved in studies because clinical research is an example of what you don’t know can hurt you,” says Dr. Gelfand, who frequently makes presentations on clinical research participation. “If you’re going to get involved in an area that’s heavily regulated because you’re experimenting with human beings, you need to know what the regulations are. I absolutely recommend that dermatologists receive that training.” Good starting places for getting a handle on what’s involved in clinical research participation are the FDA, the National Institutes of Health and the National Cancer Institute. On the non-government side, the leading resource cited by all sources is the Collaborative Institutional Training Initiative (CITI), which offers extensive training for PIs and research coordinators in all aspects of research. (See Resources below.) Most academic institutions also offer training programs in trial-based research, Dr. Gelfand notes, and the drug and device companies also provide training to PIs selected as participating sites. The most key reason to obtain adequate training before signing on is the significant risks — legal and regulatory, as well as patient safety — involved in conducting research. But novice investigators may not fully appreciate the range of risks, explains Dr. Gelfand, whose unit’s work focuses primarily in psoriasis, T-cell lymphoma and hidradenitis. “If you don’t follow the FDA regulations — or are in violation — there can be civil and criminal penalties,” Dr. Gelfand says. “Some novice investigators may not realize, for example, that having a nurse, not the dermatologist/investigator, follow the patient is a violation.” The point, Dr. Schlessinger stresses, is that clinical research is a high-stakes undertaking. “The most concerning potential [risk] is the loss of your license or criminal action against you by the FDA if you or your study site doesn’t perform the study in strict accordance with their guidelines,” he says. “The investigator can end up in jail if he does something wrong, even if it isn’t his direct fault. It’s the captain-of-the-ship theory; you are responsible for everything that happens at your site.”
Preparing the Practice for Participation
It’s possible for dermatologists to “dabble” in research — by taking on only one or two trials, with limited enrollment — without adding personnel or space. But it’s probably better to commit to a larger-scale if still modest endeavor, sources advise. That’s because the keys to successful participation are dedicated staff and setting aside specific days for research, maintains cosmetic dermatologist Leslie Baumann, MD, CEO of Baumann Cosmetic and Research Institute, in Miami Beach, FL. “It is too difficult to try to see clinic patients at the same time as research patients, in most cases. That’s when errors happen,” says Dr. Baumann, a former longtime researcher at the University of Miami, who launched her institute in 2009 and is now conducting more than 20 trials. “Research is ‘feast or famine’ — sometimes you have a lot of trials and sometimes you have none. This makes staffing difficult, but I believe you need to invest wholeheartedly and have a skilled team, or do not do it at all.” That doesn’t mean dermatologists can’t or shouldn’t participate in small physician-initiated trials and independent research, she adds. But those activities are on a completely different scale than setting up a trial center. If they’re scheduled properly, however, research tasks can occur alongside clinical practice. “Everyone should be encouraged to do independent research. The time lines are usually looser [than with large trials], so those tasks can be done with less pressure during slower times of the year,” she explains. Having a dedicated clinical trial coordinator (CTC) is a must for any practice that plans to get into research in a big way, Dr. Cather maintains. Ideally, that individual not only has substantial experience in all aspects of trials — from recruitment and screening, to lab testing and sample taking, to documentation and regulatory compliance — but also a good grounding in research ethics. “CTCs truly are an integral part of the clinical trial team,” Dr. Cather says, adding that this person should possess a diverse skill set. Often, or ideally, a master’s-prepared, clinical nurse specialist, the CTC should have good interpersonal skills to effectively interact with and motivate patients and clinic staff, as well as organizational and leadership skills. “Teaching and instructional skills are also necessary, as the CTC must explain complex issues to trial participants, including informed consent and trial protocols,” she adds. Dr. Cather notes that in a recent survey of clinical research professionals, the majority of respondents named the CTC position as the most time- and work-intensive, and the one requiring the greatest technical and interpersonal skills. “Interestingly, respondents also described it as both the most stressful and the most satisfying position,” she says. For specific information on what the CRC’s job entails, the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) are good starting places. Both offer coordinator and administrator certification programs. (See Resources below.) Adele Clark, PA-C, understands well the stress factors and rigors of the job. As director of the dermatology clinical studies center at Wake Forest University Baptist Medical Center in Winston-Salem, NC, Ms. Clark has a decade of experience in the gratifying and not so gratifying aspects of clinical research. “The coordinator’s work is very detail-oriented. Every letter must be clear, every ‘i’ dotted. You need someone who is very well organized,” says Ms. Clark, whose center includes a dedicated facility, eight dermatologists and a full-time staff of 10 who work only on clinical trials. Dermatology experience is helpful, but not a must, she says. “A coordinator who has experience in other areas can do a dermatology trial, but it helps to know about the condition and the names of the medications used,” she says, “as well as what’s seen clinically in the disease and the common side effects of medications.” Her center’s “greenest” coordinator has 4 years experience, which Ms. Clark considers just about right, given that the university might have 30 ongoing trials at any given time, mostly in psoriasis, acne and atopic dermatitis. The center also does a small number of cosmetic studies. “The coordinators and staff need to know when someone has a true infection and whether that’s related to the medication,” Ms. Clark explains. “When you have someone taking these brand-new drugs that have hardly been given to humans, you have to be prepared for that.” Michaela Bell, BS, CCRC (certified clinical research coordinator) at Dr. Baumann’s institute, cautions that the ideal coordinator, because of the skill set required, might not be the practice’s well-skilled longtime practice nurse. “It’s a totally different world from the way dermatology practices normally work. You might have a staff member who is a great nurse, but when you put her into a research trial, it’s not a good fit,” she says. Dr. Schlessinger concurs. “What I’ve found is that the same nursing staff that does wonderfully on the floor of a busy office is not usually very good at performing studies because it’s almost diametrically opposed in sense of urgency,” he explains, “from floor duties to study duties.” Space needs are also a key consideration, especially when the practice environment is already operating at maximum capacity. Depending on the protocol, the trial sponsor might suggest and even provide specialized equipment and/or resources for additional staff and space, if the company decides the site isn’t adequately sized or configured, Dr. Cather notes. But prospective investigators should assess site needs and make appropriate provisions for the long-term benefit of the site, she adds, regardless of the needs of any particular trial. Practices should also prepare for the long haul, if they’re going to make a go of it as a trial site, Dr. Schlessinger advises. “There’s a lot to be considered, and there are investments [to be made]. Unfortunately, a lot of people are being enticed into doing them because of declining reimbursement, and they don’t have a clue what they’re getting into and what the potential liabilities are. This is not the same as seeing patients.”
Resources
1. Collaborative Institutional Training Initiative (CITI), at www.citiprogram.org. 2. Food and Drug Administration, at www.fda.gov (see especially Human Subject Protection Regulations and FDA Investigator Responsibilities documents). 3. Society of Clinical Research Associates (SOCRA), at www.socra.org. 4. Association of Clinical Research Professionals (ACRP), at www.acrpnet.org.
Just the stats
The complexity and scrutiny of studies has increased dramatically in recent years. To wit: • The average number of pages investigators had to complete was 55 in 1999; it was 180 in 2006. • The average number of procedures per study patient in 1992 was 100; a decade later it was 154. • 30% of the data collected in clinical studies is not used. • Average number of inclusion and exclusion eligibility criteria is now 45 items.
Dermatologists setting up shop as a clinical trial center may see many benefits, but they also face multiple challenges. As clinical trials expand well beyond academic centers and move increasingly into the community-practice arena, many dermatologists who’ve not performed research are being enticed to give it a try. The primary appeal is the opportunity to expand the dermatologist’s — and the practice staff’s — horizons. And in this era of declining reimbursement, some practices are eyeing the remuneration of research participation as an additional revenue source. Veterans of practice-based research are quick to point out both the upsides and the sometimes considerable downsides of becoming a study site. For Dallas, TX, dermatologist Jennifer Cather, MD, who has spent a decade as a trial investigator, the experience has proved rewarding on several levels. “I have participated in cutting-edge research, provided new treatment modalities to my patients, and I’ve also had the opportunity to interact with other key investigators, scientists and industry leaders around the world,” says Dr. Cather, who has participated in and also designed several psoriasis clinical trials. “It is a great learning experience for my whole staff, and it also really helps to build our team.”
Experts’ Tips
It’s impossible to steer clear of all of the pitfalls of clinical trial research, but dermatologists can at least reduce their risk and improve their chances of success by employing diligence and forethought. Following are tips offered by sources interviewed for this article: Review the study and the product thoroughly before becoming an investigator. “Prospective investigators must scrupulously look over the content and design of the study and the entirety of the package to make sure they aren’t potentially getting involved in something that could end up blowing up in their faces.” ~ Dr. Schlessinger “Do not do a study that you feel is not safe for patients. I have turned down a filler trial when I felt the filler was not a good product.” ~ Dr. Baumann Understand the time commitment. “A crucial issue in doing a trial is understanding that the protocols take an enormous amount of effort on the part of the staff. In fact, 95% of the work of a protocol may be done behind the scene y a staff member, and only 5% by the physician.” ~ Dr. Gelfand Do negotiate the budget, particularly line items like recruitment and investigator meeting attendance. All sources recommended asking for at least minor adjustments to the budget if it seems inadequate, but noted that negotiating can be difficult. “I have found companies to be very fair, but we [our center] do have an a la carte type menu of prices — for a photo, a blood draw, a telephone visit, PI visit or injection, for example.” ~ Dr. Baumann Start with a later-phase study. All sources recommended incremental involvement, starting with Phase III or IV studies, when the drug or device has already undergone the initial safety and efficacy review. Understand the ethical issues. “As a physician, you have a lot of influence over patient decision making. You hand the patient this complicated 10-page form and the patient says, ‘What should I do, doc?’ So there’s an inherent conflict between a researcher and a clinician — as a researcher you have an obligation to research, and as a clinician you have a full obligation to the patient.” ~ Dr. Gelfand Be prepared to recruit well outside the practice. “We sometimes have a hard time recruiting patients from our practice because they come to you expecting to be treated. And if you steer them toward a trial that may be placebo-controlled that’s not the ultimate reason they came to you in some circumstances.” ~ Ms. Clark Take informed consent and staff oversight very seriously. “During the course of a trial, the consent form may go through several amendments. And if you consent the patient with the wrong version of the consent form, according to the FDA, you have not consented that patient.” ~ Dr. Gelfand
The intellectual rigor and altruistic aspects of clinical trial participation — not to mention the additional revenue — may be appealing, Dr. Cather observes. But dermatologists who’ve not been principal investigators (PIs) need to understand the requirements and the risks, financial and logistical, before taking the leap. “Serving as a study site is ultimately a business decision. As a PI it’s important to understand the overall cost implications of conducting the trial,” she explains. Those implications are numerous. Not only must the prospective PI “staff up” and make adjustments to the physical space to accommodate the research, but dermatologists must also understand that research participation is a time-consuming business. Patient recruitment, pre-screening and consent activities might require relatively minimal dermatologist involvement, but the time expenditure for staff can be enormous, longtime PI Joel Schlessinger, MD, of Omaha, NE, contends. And the up-front activities of becoming a trial site are far more demanding, for all involved, than many dermatologists realize. For example, a site-initiation visit can take from 30 minutes to several hours, and dermatologists who serve as PIs, as well as study coordinators, may be required to attend weekend-long investigator meetings. And if the site gets audited by the FDA, staff could spend many hours preparing for and dealing with that event. “There are challenges for the practice, in having the physician and staff away from the office for 1 to 3 days to ‘learn’ the study. And while research can be well compensated, the practice can actually lose money on a given trial,” Dr. Schlessinger explains, for a host of reasons. The trial may not be well enough reimbursed to provide adequate revenue, because of an onerous protocol, unexpected recruiting difficulties, or even poor study design, among other factors. “There are a lot of startups in the industry with little money to provide for the actual research,” he says, and it’s hard for novices to know beforehand whether the compensation will be adequate. In addition, because of market conditions — namely increasing competition, especially in cosmetic-treatment trials — many studies these days are reimbursing less than they used to, notes Dr. Schlessinger, president emeritus of the American Society of Cosmetic Dermatology and Aesthetic Surgery. “There are a lot of ifs, and even a study that would seem to be a slam dunk — like a simple acne study — has many potential pitfalls and may be difficult to recruit for, given the necessary criteria for the study,” Dr. Schlessinger says. Some lesser known pitfalls in that regard include: • Inordinately extensive inclusion or exclusion criteria, making it hard to identify suitable patients. • Inadequate budget, given the patient testing, monitoring and visit requirements. • Trial timing, which may translate into difficulty recruiting teens, for example, because they’re too busy with school to come into the practice for screening. • A protocol that requires a laboratory collection that’s painful — or tests that are particularly burdensome. • Failure to understand the potentially significant time commitments for the investigator and the staff, which could make it not worthwhile to participate. “It’s really hard to know some of this up front,” Dr. Schlessinger says. “No study comes with an explanatory document that says, ‘Here’s why it would or would not work.’ Clearly there are cues, but it’s challenging for the novice to know whether they’re getting a good study or a dud.” And unfortunately, even the sponsoring company’s track record might not be an indicator of whether the study will be a “winner,” Dr. Schlessinger and other sources concur.
Tally the Prerequisites; Understand the Risks
The downsides needn’t deter dermatologists from setting up shop as a trial site. But the better informed they become about research activities in general — and site space and staffing needs, in particular — the better their chance of making the enterprise a gratifying one. Joel Gelfand, MD, MSCE, medical director of the University of Pennsylvania’s Clinical Studies Unit and assistant professor of dermatology and epidemiology, urges prospective researchers to steep themselves in the big picture and the minutia before proceeding. “Dermatologists need to know a lot before they get involved in studies because clinical research is an example of what you don’t know can hurt you,” says Dr. Gelfand, who frequently makes presentations on clinical research participation. “If you’re going to get involved in an area that’s heavily regulated because you’re experimenting with human beings, you need to know what the regulations are. I absolutely recommend that dermatologists receive that training.” Good starting places for getting a handle on what’s involved in clinical research participation are the FDA, the National Institutes of Health and the National Cancer Institute. On the non-government side, the leading resource cited by all sources is the Collaborative Institutional Training Initiative (CITI), which offers extensive training for PIs and research coordinators in all aspects of research. (See Resources below.) Most academic institutions also offer training programs in trial-based research, Dr. Gelfand notes, and the drug and device companies also provide training to PIs selected as participating sites. The most key reason to obtain adequate training before signing on is the significant risks — legal and regulatory, as well as patient safety — involved in conducting research. But novice investigators may not fully appreciate the range of risks, explains Dr. Gelfand, whose unit’s work focuses primarily in psoriasis, T-cell lymphoma and hidradenitis. “If you don’t follow the FDA regulations — or are in violation — there can be civil and criminal penalties,” Dr. Gelfand says. “Some novice investigators may not realize, for example, that having a nurse, not the dermatologist/investigator, follow the patient is a violation.” The point, Dr. Schlessinger stresses, is that clinical research is a high-stakes undertaking. “The most concerning potential [risk] is the loss of your license or criminal action against you by the FDA if you or your study site doesn’t perform the study in strict accordance with their guidelines,” he says. “The investigator can end up in jail if he does something wrong, even if it isn’t his direct fault. It’s the captain-of-the-ship theory; you are responsible for everything that happens at your site.”
Preparing the Practice for Participation
It’s possible for dermatologists to “dabble” in research — by taking on only one or two trials, with limited enrollment — without adding personnel or space. But it’s probably better to commit to a larger-scale if still modest endeavor, sources advise. That’s because the keys to successful participation are dedicated staff and setting aside specific days for research, maintains cosmetic dermatologist Leslie Baumann, MD, CEO of Baumann Cosmetic and Research Institute, in Miami Beach, FL. “It is too difficult to try to see clinic patients at the same time as research patients, in most cases. That’s when errors happen,” says Dr. Baumann, a former longtime researcher at the University of Miami, who launched her institute in 2009 and is now conducting more than 20 trials. “Research is ‘feast or famine’ — sometimes you have a lot of trials and sometimes you have none. This makes staffing difficult, but I believe you need to invest wholeheartedly and have a skilled team, or do not do it at all.” That doesn’t mean dermatologists can’t or shouldn’t participate in small physician-initiated trials and independent research, she adds. But those activities are on a completely different scale than setting up a trial center. If they’re scheduled properly, however, research tasks can occur alongside clinical practice. “Everyone should be encouraged to do independent research. The time lines are usually looser [than with large trials], so those tasks can be done with less pressure during slower times of the year,” she explains. Having a dedicated clinical trial coordinator (CTC) is a must for any practice that plans to get into research in a big way, Dr. Cather maintains. Ideally, that individual not only has substantial experience in all aspects of trials — from recruitment and screening, to lab testing and sample taking, to documentation and regulatory compliance — but also a good grounding in research ethics. “CTCs truly are an integral part of the clinical trial team,” Dr. Cather says, adding that this person should possess a diverse skill set. Often, or ideally, a master’s-prepared, clinical nurse specialist, the CTC should have good interpersonal skills to effectively interact with and motivate patients and clinic staff, as well as organizational and leadership skills. “Teaching and instructional skills are also necessary, as the CTC must explain complex issues to trial participants, including informed consent and trial protocols,” she adds. Dr. Cather notes that in a recent survey of clinical research professionals, the majority of respondents named the CTC position as the most time- and work-intensive, and the one requiring the greatest technical and interpersonal skills. “Interestingly, respondents also described it as both the most stressful and the most satisfying position,” she says. For specific information on what the CRC’s job entails, the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) are good starting places. Both offer coordinator and administrator certification programs. (See Resources below.) Adele Clark, PA-C, understands well the stress factors and rigors of the job. As director of the dermatology clinical studies center at Wake Forest University Baptist Medical Center in Winston-Salem, NC, Ms. Clark has a decade of experience in the gratifying and not so gratifying aspects of clinical research. “The coordinator’s work is very detail-oriented. Every letter must be clear, every ‘i’ dotted. You need someone who is very well organized,” says Ms. Clark, whose center includes a dedicated facility, eight dermatologists and a full-time staff of 10 who work only on clinical trials. Dermatology experience is helpful, but not a must, she says. “A coordinator who has experience in other areas can do a dermatology trial, but it helps to know about the condition and the names of the medications used,” she says, “as well as what’s seen clinically in the disease and the common side effects of medications.” Her center’s “greenest” coordinator has 4 years experience, which Ms. Clark considers just about right, given that the university might have 30 ongoing trials at any given time, mostly in psoriasis, acne and atopic dermatitis. The center also does a small number of cosmetic studies. “The coordinators and staff need to know when someone has a true infection and whether that’s related to the medication,” Ms. Clark explains. “When you have someone taking these brand-new drugs that have hardly been given to humans, you have to be prepared for that.” Michaela Bell, BS, CCRC (certified clinical research coordinator) at Dr. Baumann’s institute, cautions that the ideal coordinator, because of the skill set required, might not be the practice’s well-skilled longtime practice nurse. “It’s a totally different world from the way dermatology practices normally work. You might have a staff member who is a great nurse, but when you put her into a research trial, it’s not a good fit,” she says. Dr. Schlessinger concurs. “What I’ve found is that the same nursing staff that does wonderfully on the floor of a busy office is not usually very good at performing studies because it’s almost diametrically opposed in sense of urgency,” he explains, “from floor duties to study duties.” Space needs are also a key consideration, especially when the practice environment is already operating at maximum capacity. Depending on the protocol, the trial sponsor might suggest and even provide specialized equipment and/or resources for additional staff and space, if the company decides the site isn’t adequately sized or configured, Dr. Cather notes. But prospective investigators should assess site needs and make appropriate provisions for the long-term benefit of the site, she adds, regardless of the needs of any particular trial. Practices should also prepare for the long haul, if they’re going to make a go of it as a trial site, Dr. Schlessinger advises. “There’s a lot to be considered, and there are investments [to be made]. Unfortunately, a lot of people are being enticed into doing them because of declining reimbursement, and they don’t have a clue what they’re getting into and what the potential liabilities are. This is not the same as seeing patients.”
Resources
1. Collaborative Institutional Training Initiative (CITI), at www.citiprogram.org. 2. Food and Drug Administration, at www.fda.gov (see especially Human Subject Protection Regulations and FDA Investigator Responsibilities documents). 3. Society of Clinical Research Associates (SOCRA), at www.socra.org. 4. Association of Clinical Research Professionals (ACRP), at www.acrpnet.org.
Just the stats
The complexity and scrutiny of studies has increased dramatically in recent years. To wit: • The average number of pages investigators had to complete was 55 in 1999; it was 180 in 2006. • The average number of procedures per study patient in 1992 was 100; a decade later it was 154. • 30% of the data collected in clinical studies is not used. • Average number of inclusion and exclusion eligibility criteria is now 45 items.
Dermatologists setting up shop as a clinical trial center may see many benefits, but they also face multiple challenges. As clinical trials expand well beyond academic centers and move increasingly into the community-practice arena, many dermatologists who’ve not performed research are being enticed to give it a try. The primary appeal is the opportunity to expand the dermatologist’s — and the practice staff’s — horizons. And in this era of declining reimbursement, some practices are eyeing the remuneration of research participation as an additional revenue source. Veterans of practice-based research are quick to point out both the upsides and the sometimes considerable downsides of becoming a study site. For Dallas, TX, dermatologist Jennifer Cather, MD, who has spent a decade as a trial investigator, the experience has proved rewarding on several levels. “I have participated in cutting-edge research, provided new treatment modalities to my patients, and I’ve also had the opportunity to interact with other key investigators, scientists and industry leaders around the world,” says Dr. Cather, who has participated in and also designed several psoriasis clinical trials. “It is a great learning experience for my whole staff, and it also really helps to build our team.”
Experts’ Tips
It’s impossible to steer clear of all of the pitfalls of clinical trial research, but dermatologists can at least reduce their risk and improve their chances of success by employing diligence and forethought. Following are tips offered by sources interviewed for this article: Review the study and the product thoroughly before becoming an investigator. “Prospective investigators must scrupulously look over the content and design of the study and the entirety of the package to make sure they aren’t potentially getting involved in something that could end up blowing up in their faces.” ~ Dr. Schlessinger “Do not do a study that you feel is not safe for patients. I have turned down a filler trial when I felt the filler was not a good product.” ~ Dr. Baumann Understand the time commitment. “A crucial issue in doing a trial is understanding that the protocols take an enormous amount of effort on the part of the staff. In fact, 95% of the work of a protocol may be done behind the scene y a staff member, and only 5% by the physician.” ~ Dr. Gelfand Do negotiate the budget, particularly line items like recruitment and investigator meeting attendance. All sources recommended asking for at least minor adjustments to the budget if it seems inadequate, but noted that negotiating can be difficult. “I have found companies to be very fair, but we [our center] do have an a la carte type menu of prices — for a photo, a blood draw, a telephone visit, PI visit or injection, for example.” ~ Dr. Baumann Start with a later-phase study. All sources recommended incremental involvement, starting with Phase III or IV studies, when the drug or device has already undergone the initial safety and efficacy review. Understand the ethical issues. “As a physician, you have a lot of influence over patient decision making. You hand the patient this complicated 10-page form and the patient says, ‘What should I do, doc?’ So there’s an inherent conflict between a researcher and a clinician — as a researcher you have an obligation to research, and as a clinician you have a full obligation to the patient.” ~ Dr. Gelfand Be prepared to recruit well outside the practice. “We sometimes have a hard time recruiting patients from our practice because they come to you expecting to be treated. And if you steer them toward a trial that may be placebo-controlled that’s not the ultimate reason they came to you in some circumstances.” ~ Ms. Clark Take informed consent and staff oversight very seriously. “During the course of a trial, the consent form may go through several amendments. And if you consent the patient with the wrong version of the consent form, according to the FDA, you have not consented that patient.” ~ Dr. Gelfand
The intellectual rigor and altruistic aspects of clinical trial participation — not to mention the additional revenue — may be appealing, Dr. Cather observes. But dermatologists who’ve not been principal investigators (PIs) need to understand the requirements and the risks, financial and logistical, before taking the leap. “Serving as a study site is ultimately a business decision. As a PI it’s important to understand the overall cost implications of conducting the trial,” she explains. Those implications are numerous. Not only must the prospective PI “staff up” and make adjustments to the physical space to accommodate the research, but dermatologists must also understand that research participation is a time-consuming business. Patient recruitment, pre-screening and consent activities might require relatively minimal dermatologist involvement, but the time expenditure for staff can be enormous, longtime PI Joel Schlessinger, MD, of Omaha, NE, contends. And the up-front activities of becoming a trial site are far more demanding, for all involved, than many dermatologists realize. For example, a site-initiation visit can take from 30 minutes to several hours, and dermatologists who serve as PIs, as well as study coordinators, may be required to attend weekend-long investigator meetings. And if the site gets audited by the FDA, staff could spend many hours preparing for and dealing with that event. “There are challenges for the practice, in having the physician and staff away from the office for 1 to 3 days to ‘learn’ the study. And while research can be well compensated, the practice can actually lose money on a given trial,” Dr. Schlessinger explains, for a host of reasons. The trial may not be well enough reimbursed to provide adequate revenue, because of an onerous protocol, unexpected recruiting difficulties, or even poor study design, among other factors. “There are a lot of startups in the industry with little money to provide for the actual research,” he says, and it’s hard for novices to know beforehand whether the compensation will be adequate. In addition, because of market conditions — namely increasing competition, especially in cosmetic-treatment trials — many studies these days are reimbursing less than they used to, notes Dr. Schlessinger, president emeritus of the American Society of Cosmetic Dermatology and Aesthetic Surgery. “There are a lot of ifs, and even a study that would seem to be a slam dunk — like a simple acne study — has many potential pitfalls and may be difficult to recruit for, given the necessary criteria for the study,” Dr. Schlessinger says. Some lesser known pitfalls in that regard include: • Inordinately extensive inclusion or exclusion criteria, making it hard to identify suitable patients. • Inadequate budget, given the patient testing, monitoring and visit requirements. • Trial timing, which may translate into difficulty recruiting teens, for example, because they’re too busy with school to come into the practice for screening. • A protocol that requires a laboratory collection that’s painful — or tests that are particularly burdensome. • Failure to understand the potentially significant time commitments for the investigator and the staff, which could make it not worthwhile to participate. “It’s really hard to know some of this up front,” Dr. Schlessinger says. “No study comes with an explanatory document that says, ‘Here’s why it would or would not work.’ Clearly there are cues, but it’s challenging for the novice to know whether they’re getting a good study or a dud.” And unfortunately, even the sponsoring company’s track record might not be an indicator of whether the study will be a “winner,” Dr. Schlessinger and other sources concur.
Tally the Prerequisites; Understand the Risks
The downsides needn’t deter dermatologists from setting up shop as a trial site. But the better informed they become about research activities in general — and site space and staffing needs, in particular — the better their chance of making the enterprise a gratifying one. Joel Gelfand, MD, MSCE, medical director of the University of Pennsylvania’s Clinical Studies Unit and assistant professor of dermatology and epidemiology, urges prospective researchers to steep themselves in the big picture and the minutia before proceeding. “Dermatologists need to know a lot before they get involved in studies because clinical research is an example of what you don’t know can hurt you,” says Dr. Gelfand, who frequently makes presentations on clinical research participation. “If you’re going to get involved in an area that’s heavily regulated because you’re experimenting with human beings, you need to know what the regulations are. I absolutely recommend that dermatologists receive that training.” Good starting places for getting a handle on what’s involved in clinical research participation are the FDA, the National Institutes of Health and the National Cancer Institute. On the non-government side, the leading resource cited by all sources is the Collaborative Institutional Training Initiative (CITI), which offers extensive training for PIs and research coordinators in all aspects of research. (See Resources below.) Most academic institutions also offer training programs in trial-based research, Dr. Gelfand notes, and the drug and device companies also provide training to PIs selected as participating sites. The most key reason to obtain adequate training before signing on is the significant risks — legal and regulatory, as well as patient safety — involved in conducting research. But novice investigators may not fully appreciate the range of risks, explains Dr. Gelfand, whose unit’s work focuses primarily in psoriasis, T-cell lymphoma and hidradenitis. “If you don’t follow the FDA regulations — or are in violation — there can be civil and criminal penalties,” Dr. Gelfand says. “Some novice investigators may not realize, for example, that having a nurse, not the dermatologist/investigator, follow the patient is a violation.” The point, Dr. Schlessinger stresses, is that clinical research is a high-stakes undertaking. “The most concerning potential [risk] is the loss of your license or criminal action against you by the FDA if you or your study site doesn’t perform the study in strict accordance with their guidelines,” he says. “The investigator can end up in jail if he does something wrong, even if it isn’t his direct fault. It’s the captain-of-the-ship theory; you are responsible for everything that happens at your site.”
Preparing the Practice for Participation
It’s possible for dermatologists to “dabble” in research — by taking on only one or two trials, with limited enrollment — without adding personnel or space. But it’s probably better to commit to a larger-scale if still modest endeavor, sources advise. That’s because the keys to successful participation are dedicated staff and setting aside specific days for research, maintains cosmetic dermatologist Leslie Baumann, MD, CEO of Baumann Cosmetic and Research Institute, in Miami Beach, FL. “It is too difficult to try to see clinic patients at the same time as research patients, in most cases. That’s when errors happen,” says Dr. Baumann, a former longtime researcher at the University of Miami, who launched her institute in 2009 and is now conducting more than 20 trials. “Research is ‘feast or famine’ — sometimes you have a lot of trials and sometimes you have none. This makes staffing difficult, but I believe you need to invest wholeheartedly and have a skilled team, or do not do it at all.” That doesn’t mean dermatologists can’t or shouldn’t participate in small physician-initiated trials and independent research, she adds. But those activities are on a completely different scale than setting up a trial center. If they’re scheduled properly, however, research tasks can occur alongside clinical practice. “Everyone should be encouraged to do independent research. The time lines are usually looser [than with large trials], so those tasks can be done with less pressure during slower times of the year,” she explains. Having a dedicated clinical trial coordinator (CTC) is a must for any practice that plans to get into research in a big way, Dr. Cather maintains. Ideally, that individual not only has substantial experience in all aspects of trials — from recruitment and screening, to lab testing and sample taking, to documentation and regulatory compliance — but also a good grounding in research ethics. “CTCs truly are an integral part of the clinical trial team,” Dr. Cather says, adding that this person should possess a diverse skill set. Often, or ideally, a master’s-prepared, clinical nurse specialist, the CTC should have good interpersonal skills to effectively interact with and motivate patients and clinic staff, as well as organizational and leadership skills. “Teaching and instructional skills are also necessary, as the CTC must explain complex issues to trial participants, including informed consent and trial protocols,” she adds. Dr. Cather notes that in a recent survey of clinical research professionals, the majority of respondents named the CTC position as the most time- and work-intensive, and the one requiring the greatest technical and interpersonal skills. “Interestingly, respondents also described it as both the most stressful and the most satisfying position,” she says. For specific information on what the CRC’s job entails, the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) are good starting places. Both offer coordinator and administrator certification programs. (See Resources below.) Adele Clark, PA-C, understands well the stress factors and rigors of the job. As director of the dermatology clinical studies center at Wake Forest University Baptist Medical Center in Winston-Salem, NC, Ms. Clark has a decade of experience in the gratifying and not so gratifying aspects of clinical research. “The coordinator’s work is very detail-oriented. Every letter must be clear, every ‘i’ dotted. You need someone who is very well organized,” says Ms. Clark, whose center includes a dedicated facility, eight dermatologists and a full-time staff of 10 who work only on clinical trials. Dermatology experience is helpful, but not a must, she says. “A coordinator who has experience in other areas can do a dermatology trial, but it helps to know about the condition and the names of the medications used,” she says, “as well as what’s seen clinically in the disease and the common side effects of medications.” Her center’s “greenest” coordinator has 4 years experience, which Ms. Clark considers just about right, given that the university might have 30 ongoing trials at any given time, mostly in psoriasis, acne and atopic dermatitis. The center also does a small number of cosmetic studies. “The coordinators and staff need to know when someone has a true infection and whether that’s related to the medication,” Ms. Clark explains. “When you have someone taking these brand-new drugs that have hardly been given to humans, you have to be prepared for that.” Michaela Bell, BS, CCRC (certified clinical research coordinator) at Dr. Baumann’s institute, cautions that the ideal coordinator, because of the skill set required, might not be the practice’s well-skilled longtime practice nurse. “It’s a totally different world from the way dermatology practices normally work. You might have a staff member who is a great nurse, but when you put her into a research trial, it’s not a good fit,” she says. Dr. Schlessinger concurs. “What I’ve found is that the same nursing staff that does wonderfully on the floor of a busy office is not usually very good at performing studies because it’s almost diametrically opposed in sense of urgency,” he explains, “from floor duties to study duties.” Space needs are also a key consideration, especially when the practice environment is already operating at maximum capacity. Depending on the protocol, the trial sponsor might suggest and even provide specialized equipment and/or resources for additional staff and space, if the company decides the site isn’t adequately sized or configured, Dr. Cather notes. But prospective investigators should assess site needs and make appropriate provisions for the long-term benefit of the site, she adds, regardless of the needs of any particular trial. Practices should also prepare for the long haul, if they’re going to make a go of it as a trial site, Dr. Schlessinger advises. “There’s a lot to be considered, and there are investments [to be made]. Unfortunately, a lot of people are being enticed into doing them because of declining reimbursement, and they don’t have a clue what they’re getting into and what the potential liabilities are. This is not the same as seeing patients.”
Resources
1. Collaborative Institutional Training Initiative (CITI), at www.citiprogram.org. 2. Food and Drug Administration, at www.fda.gov (see especially Human Subject Protection Regulations and FDA Investigator Responsibilities documents). 3. Society of Clinical Research Associates (SOCRA), at www.socra.org. 4. Association of Clinical Research Professionals (ACRP), at www.acrpnet.org.
Just the stats
The complexity and scrutiny of studies has increased dramatically in recent years. To wit: • The average number of pages investigators had to complete was 55 in 1999; it was 180 in 2006. • The average number of procedures per study patient in 1992 was 100; a decade later it was 154. • 30% of the data collected in clinical studies is not used. • Average number of inclusion and exclusion eligibility criteria is now 45 items.
