Clinical trials help find new treatments that work, and can ensure that drugs are safe for patients. Clinical trials are also conducted to compare existing treatments to determine which are better, to determine if off-label uses of drugs are safe and effective, and to find the best ways to use standard treatments.
But how hard is it really to get involved in clinical trials? And should you do it?
While the answer may be yes for many doctors, most, evidently, are unconvinced. A 2004 survey by Health Care News found that 53% of practicing physicians said they had never participated in a clinical trial, while only 13% said they were running a study at the time. Doctors who didn’t conduct studies cited a lack of time, personnel, and resources, along with the burden of regulations, as the main reasons for not getting involved in research.
Surveys notwithstanding, interviews with dermatologists who participate in clinical research suggest that conducting studies can be professionally, intellectually, and, for some, financially rewarding.
“It allows you to give your patients cutting-edge treatment at a severely discounted price or for free,” says Dr. Mitchel Goldman, Medical Director of La Jolla Spa MD, in La Jolla, CA.
And, since according to Clinical-Trials.gov, there are 28,875 studies currently listed, opportunities are available. Of the 28,875 trials listed on the site, which is a service of the U.S. National Institutes of Health and developed by the National Library of Medicine, 12,430 are currently recruiting patients. According to the site, there are 49 trials recruiting patients for psoriasis trials, seven for acne vulgaris and 181 for melanoma.
“It’s exciting to be involved in the development of new products, and to be able to offer patients new options (for treatment),” echoes Steven R. Feldman, M.D., Ph.D., of Wake Forest University Baptist Medical Center in Winston-Salem, N.C. “Also, in an era where managed care is paying less for each office visit, you can charge your usual office rate” for patients enrolled in trials.
On the other hand, Dr. Goldman says, trials create their share of headaches. “It is a big responsibility and a potential financial drain on the practice.”
What You Need to Start Conducting Clinical Trials
For starters, any physician hoping to conduct regular trials will have to have dedicated — or, at the very least, specially trained — staff. La Jolla Spa has three full-time research nurses to handle the nine or so studies going on at any given time, Dr. Goldman says. The office also has separate exam rooms and filing systems to keep study patient records apart from those of regular office visitors.
Clinical trials are the raison d'être of academic medicine (along with teaching), so the infrastructure and support staff is already in place.
“I think a key advantage of an academic medical center is that they typically have lots of people well trained in FDA regulations and proper documentation,” says Joel M. Gelfand, M.D., Medical Director of the Clinical Studies Unit of the University of Pennsylvania’s Department of Dermatology. “The investigator has to have a very strong understanding of the federal regulations governing human subjects. And the regulations are as thick as a phone book.”
Dr. Gelfand has a master’s degree in epidemiology in addition to his M.D., giving him formal training into study design and research ethics. Study nurses in the unit also receive formal training in how to run studies properly, and are certified by a national body, the Society of Clinical Research Associates (SOCRA).
The dense bureaucracy, higher overhead costs, and lengthy institutional review board (IRB) process — intended to protect study subjects — are powerful incentives for drug companies to look off-campus for study centers. IRBs are a particularly glaring difference between academic and private settings. Universities typically send their study consent forms to local IRBs, made up of academics, religious and community representatives, and others; getting everyone to sign off of on the project can take several weeks.
Private practitioners have it easier, generally relying on national IRBs that are much more efficient (at the price, some might argue, of somewhat less sensitivity to the regional differences of study volunteers). The result is that private practice sites can start recruitment much more quickly than academic institutions.
However, private practice or not, hiring qualified staff and following all the regulations of the FDA and the drug study protocol are imperative. Not doing so can result in fines, exclusion from drug study participation or even loss of license. In fact, one dermatology practice in Pennsylvania used a clinical coordinator, who was not a physician, to examine research participants at various time intervals to measure the effectiveness of the drug being studied in the clinical trial — although the study protocol required the dermatologist to do the actual examinations. The data submitted back to the company that funded the study indicated that the study had been performed by the dermatologist. As this was not the case, the practice and the dermatologist involved were investigated. As part of a final plea agreement in this case, the practice was fined more than $100,000 and was required to pay restitution in the amount it had been paid to participate in the trial.
Start with What You Know
With anywhere from two to four clinical trials running at a time, Dr. Scott Gottlieb’s Exton, PA, office is a good example of a small practice that incorporates studies as a minority of its patient load. No more than about 5% of Dr. Gottlieb’s patients are enrolled in trials at any given time, he says.
“It really takes a big time commitment. There’s a lot of paperwork, a lot of hassle. I don’t think the financial reward is a reason to do it. You have to be interested in the topics you’re researching.”
In Dr. Gottlieb’s case, that’s psoriasis, so most of the trials he runs involve new therapies for that condition. He was able to use his contacts in the world of psoriasis research to land his first clinical trial, about 4 years ago. “I let it be known that I was interested. Once you get one, you can get others.”
Like most physicians, Dr. Gottlieb handles trials from Phase I, testing safety, through Phase IV, so-called “post-marketing” studies.
“I think it’s easiest doing Phase III and IV trials because you have the experience of the Phase I and II trials upon which to base your study. You already know a significant amount about potential side effects — and from a safety standpoint they’re probably a little safer to do.”
Still, the potential for unforeseen side effects always exists, Dr. Gottlieb says, so he makes himself available “24/7” to all his study subjects just as if they were his usual patients. (Drug companies should also have round-the-clock coverage, he adds.) However, he also includes his cell phone number on the consent form rather than the answering service number he provides other patients.
Spatial Relations
Even if you think you’ve got the time, resources and staff to take on trial patients, stop and ask yourself this: Can they all fit in my office?
“If you see 60 patients a day out of three or four exam rooms, and you want to start doing a substantial amount of clinical research work, you’ll need more space than what you have,” said Craig L. Leonardi, M.D., a St. Louis, MO, dermatologist.
In addition to accommodating additional staff and the endless stream of paperwork associated with trials, the office should have a comfortable place for research auditors — either from the company sponsor or the contract organization running the study — to sit when they comb through the records. Dr. Leonardi also warns that for many clinical trials the office will need an area for taking photographs.
“We have rooms with limited access where drugs and cameras are stored,” he says. “You might have a need for a -70˚F freezer and fridges that have to be locked at the end of the day.” Fortunately, Dr. Leonardi says, when he was hunting for office space he found a building with enough room. But for doctors already in practice the limits of their existing space will help determine how many trials they can run.
Dr. Leonardi has been conducting clinical trials out of his office since leaving his academic post at St. Louis University in 1999. He set up the practice with the intention of keeping it afloat with revenue from trials. In any given month he has between 12 to 15 studies running. By the end of this year, thanks to an acne trial with 60 patients, he’ll be seeing roughly 200 study participants under research protocols, representing about a quarter to half of his daily patient load.
Negotiating Contracts
While Dr. Leonardi was actively involved in research as an academic dermatologist, both at St. Louis University and the University of Miami, he had to learn about trials on the fly in private practice. One critical area he was unprepared for involved negotiating contracts with industry — something Dr. Leonardi says most doctors are “clueless” about.
“You have to be very careful when negotiating contracts,” he says. To be sure, the deal should be worth it for the clinician in dollars and time. “You get paid for what you do — exams, evaluations — and there’s a dollar amount affixed to every one of these things.”
Equally important, the document should be clear about liability. As in: the physician is free and clear of any claim against the company or the drug or device being tested. “Companies love to share that adventure with you, and you have to push back hard,” Dr. Leonardi quips.
Dr. Leonardi’s attorney reviews every contract he seriously considers, looking in particular for clauses that could land him major financial strain, or worse. And he’s not afraid to walk away from contracts that insist he assume a share of the liability — just as he has turned down contracts with unworkable budgets (he also has a consultant review study budgets for potential pots of red ink). “We’re a small private practice. We can’t be involved in indemnifying pharmaceutical companies,” Dr. Leonardi says.
On the other hand, Dr. Jeffrey Dover and his colleagues at SkinCare Physicians of Chestnut Hill, near Boston, occasionally take on money losing trials if they’re especially keen on the research question. “We can’t afford to do a whole bunch of studies in which we lose money, but we do them occasionally because we’re interested in the answer,” says Dr. Dover, who adds that most of the group’s studies involving lasers have been self-funded.
Recruitment, Recruitment, Recruitment
It’s certainly possible to make money running trials, and the lesson seems to be the more studies and subjects, the better the chances of being profitable.
But even the most enthusiastic investigator will fall flat without the most valuable commodity in clinical research: volunteers. The ability to recruit study subjects is key both to answering scientific questions and, for physicians, making trials pay for themselves.
“In private practice you can get up and running quicker than a university can, but if you don’t have access to a big enough pool of subjects, it can be a problem,” says Dr. David Fivenson, an Ann Arbor dermatologist who went into private practice after years of running clinical trials at Henry Ford Hospital in Detroit.
“On paper, by contract, I will have a couple hundred thousand dollars worth of trials by the end of the year. But whether I can accomplish that remains to be seen,” Dr. Fivenson says. “If you don’t recruit anyone, [the company] can pull the contract.”
Most drug companies push for competitive enrollment, meaning some sites can recruit more than others and get to keep them, he says. In the past year, Dr. Fivenson was the first site to fully enroll in two trials, and he also got the highest number of recruits in one study.
But that success has not been particularly easy to win. When he started his practice, Dr. Fivenson expected that as home to the University of Michigan, Ann Arbor would be an easy place to enroll study volunteers. Not so.
“Even though I can get advertising easier, this is an affluent community and there’s not enough motivation to participate. They’d rather just have their quality health care.”
What’s more, students aren’t typically the demographic of most studies. “Students are young, healthy people. They don’t have diseases like venous leg ulcers or bad psoriasis.”
Taking the First Step to Participation
Convinced clinical trials are for you but not sure what steps to take first? Dr. Fivenson recommends CenterWatch, an online search engine that lists tens of thousands of clinical trials funded by government and industry. In addition, some contract research organizations maintain their own registries. And, he adds, make sure to stay current on the developments in your specialty and communicate with the companies that are producing therapies in that area.
Most important, approach the work with the proper mindset. Dr. Dover, who has been conducting trials for 20 years, says making money shouldn’t be the prime mover. “We do them because of scientific curiosity. They’re fun, and they make practice that much more fun.”
Clinical trials help find new treatments that work, and can ensure that drugs are safe for patients. Clinical trials are also conducted to compare existing treatments to determine which are better, to determine if off-label uses of drugs are safe and effective, and to find the best ways to use standard treatments.
But how hard is it really to get involved in clinical trials? And should you do it?
While the answer may be yes for many doctors, most, evidently, are unconvinced. A 2004 survey by Health Care News found that 53% of practicing physicians said they had never participated in a clinical trial, while only 13% said they were running a study at the time. Doctors who didn’t conduct studies cited a lack of time, personnel, and resources, along with the burden of regulations, as the main reasons for not getting involved in research.
Surveys notwithstanding, interviews with dermatologists who participate in clinical research suggest that conducting studies can be professionally, intellectually, and, for some, financially rewarding.
“It allows you to give your patients cutting-edge treatment at a severely discounted price or for free,” says Dr. Mitchel Goldman, Medical Director of La Jolla Spa MD, in La Jolla, CA.
And, since according to Clinical-Trials.gov, there are 28,875 studies currently listed, opportunities are available. Of the 28,875 trials listed on the site, which is a service of the U.S. National Institutes of Health and developed by the National Library of Medicine, 12,430 are currently recruiting patients. According to the site, there are 49 trials recruiting patients for psoriasis trials, seven for acne vulgaris and 181 for melanoma.
“It’s exciting to be involved in the development of new products, and to be able to offer patients new options (for treatment),” echoes Steven R. Feldman, M.D., Ph.D., of Wake Forest University Baptist Medical Center in Winston-Salem, N.C. “Also, in an era where managed care is paying less for each office visit, you can charge your usual office rate” for patients enrolled in trials.
On the other hand, Dr. Goldman says, trials create their share of headaches. “It is a big responsibility and a potential financial drain on the practice.”
What You Need to Start Conducting Clinical Trials
For starters, any physician hoping to conduct regular trials will have to have dedicated — or, at the very least, specially trained — staff. La Jolla Spa has three full-time research nurses to handle the nine or so studies going on at any given time, Dr. Goldman says. The office also has separate exam rooms and filing systems to keep study patient records apart from those of regular office visitors.
Clinical trials are the raison d'être of academic medicine (along with teaching), so the infrastructure and support staff is already in place.
“I think a key advantage of an academic medical center is that they typically have lots of people well trained in FDA regulations and proper documentation,” says Joel M. Gelfand, M.D., Medical Director of the Clinical Studies Unit of the University of Pennsylvania’s Department of Dermatology. “The investigator has to have a very strong understanding of the federal regulations governing human subjects. And the regulations are as thick as a phone book.”
Dr. Gelfand has a master’s degree in epidemiology in addition to his M.D., giving him formal training into study design and research ethics. Study nurses in the unit also receive formal training in how to run studies properly, and are certified by a national body, the Society of Clinical Research Associates (SOCRA).
The dense bureaucracy, higher overhead costs, and lengthy institutional review board (IRB) process — intended to protect study subjects — are powerful incentives for drug companies to look off-campus for study centers. IRBs are a particularly glaring difference between academic and private settings. Universities typically send their study consent forms to local IRBs, made up of academics, religious and community representatives, and others; getting everyone to sign off of on the project can take several weeks.
Private practitioners have it easier, generally relying on national IRBs that are much more efficient (at the price, some might argue, of somewhat less sensitivity to the regional differences of study volunteers). The result is that private practice sites can start recruitment much more quickly than academic institutions.
However, private practice or not, hiring qualified staff and following all the regulations of the FDA and the drug study protocol are imperative. Not doing so can result in fines, exclusion from drug study participation or even loss of license. In fact, one dermatology practice in Pennsylvania used a clinical coordinator, who was not a physician, to examine research participants at various time intervals to measure the effectiveness of the drug being studied in the clinical trial — although the study protocol required the dermatologist to do the actual examinations. The data submitted back to the company that funded the study indicated that the study had been performed by the dermatologist. As this was not the case, the practice and the dermatologist involved were investigated. As part of a final plea agreement in this case, the practice was fined more than $100,000 and was required to pay restitution in the amount it had been paid to participate in the trial.
Start with What You Know
With anywhere from two to four clinical trials running at a time, Dr. Scott Gottlieb’s Exton, PA, office is a good example of a small practice that incorporates studies as a minority of its patient load. No more than about 5% of Dr. Gottlieb’s patients are enrolled in trials at any given time, he says.
“It really takes a big time commitment. There’s a lot of paperwork, a lot of hassle. I don’t think the financial reward is a reason to do it. You have to be interested in the topics you’re researching.”
In Dr. Gottlieb’s case, that’s psoriasis, so most of the trials he runs involve new therapies for that condition. He was able to use his contacts in the world of psoriasis research to land his first clinical trial, about 4 years ago. “I let it be known that I was interested. Once you get one, you can get others.”
Like most physicians, Dr. Gottlieb handles trials from Phase I, testing safety, through Phase IV, so-called “post-marketing” studies.
“I think it’s easiest doing Phase III and IV trials because you have the experience of the Phase I and II trials upon which to base your study. You already know a significant amount about potential side effects — and from a safety standpoint they’re probably a little safer to do.”
Still, the potential for unforeseen side effects always exists, Dr. Gottlieb says, so he makes himself available “24/7” to all his study subjects just as if they were his usual patients. (Drug companies should also have round-the-clock coverage, he adds.) However, he also includes his cell phone number on the consent form rather than the answering service number he provides other patients.
Spatial Relations
Even if you think you’ve got the time, resources and staff to take on trial patients, stop and ask yourself this: Can they all fit in my office?
“If you see 60 patients a day out of three or four exam rooms, and you want to start doing a substantial amount of clinical research work, you’ll need more space than what you have,” said Craig L. Leonardi, M.D., a St. Louis, MO, dermatologist.
In addition to accommodating additional staff and the endless stream of paperwork associated with trials, the office should have a comfortable place for research auditors — either from the company sponsor or the contract organization running the study — to sit when they comb through the records. Dr. Leonardi also warns that for many clinical trials the office will need an area for taking photographs.
“We have rooms with limited access where drugs and cameras are stored,” he says. “You might have a need for a -70˚F freezer and fridges that have to be locked at the end of the day.” Fortunately, Dr. Leonardi says, when he was hunting for office space he found a building with enough room. But for doctors already in practice the limits of their existing space will help determine how many trials they can run.
Dr. Leonardi has been conducting clinical trials out of his office since leaving his academic post at St. Louis University in 1999. He set up the practice with the intention of keeping it afloat with revenue from trials. In any given month he has between 12 to 15 studies running. By the end of this year, thanks to an acne trial with 60 patients, he’ll be seeing roughly 200 study participants under research protocols, representing about a quarter to half of his daily patient load.
Negotiating Contracts
While Dr. Leonardi was actively involved in research as an academic dermatologist, both at St. Louis University and the University of Miami, he had to learn about trials on the fly in private practice. One critical area he was unprepared for involved negotiating contracts with industry — something Dr. Leonardi says most doctors are “clueless” about.
“You have to be very careful when negotiating contracts,” he says. To be sure, the deal should be worth it for the clinician in dollars and time. “You get paid for what you do — exams, evaluations — and there’s a dollar amount affixed to every one of these things.”
Equally important, the document should be clear about liability. As in: the physician is free and clear of any claim against the company or the drug or device being tested. “Companies love to share that adventure with you, and you have to push back hard,” Dr. Leonardi quips.
Dr. Leonardi’s attorney reviews every contract he seriously considers, looking in particular for clauses that could land him major financial strain, or worse. And he’s not afraid to walk away from contracts that insist he assume a share of the liability — just as he has turned down contracts with unworkable budgets (he also has a consultant review study budgets for potential pots of red ink). “We’re a small private practice. We can’t be involved in indemnifying pharmaceutical companies,” Dr. Leonardi says.
On the other hand, Dr. Jeffrey Dover and his colleagues at SkinCare Physicians of Chestnut Hill, near Boston, occasionally take on money losing trials if they’re especially keen on the research question. “We can’t afford to do a whole bunch of studies in which we lose money, but we do them occasionally because we’re interested in the answer,” says Dr. Dover, who adds that most of the group’s studies involving lasers have been self-funded.
Recruitment, Recruitment, Recruitment
It’s certainly possible to make money running trials, and the lesson seems to be the more studies and subjects, the better the chances of being profitable.
But even the most enthusiastic investigator will fall flat without the most valuable commodity in clinical research: volunteers. The ability to recruit study subjects is key both to answering scientific questions and, for physicians, making trials pay for themselves.
“In private practice you can get up and running quicker than a university can, but if you don’t have access to a big enough pool of subjects, it can be a problem,” says Dr. David Fivenson, an Ann Arbor dermatologist who went into private practice after years of running clinical trials at Henry Ford Hospital in Detroit.
“On paper, by contract, I will have a couple hundred thousand dollars worth of trials by the end of the year. But whether I can accomplish that remains to be seen,” Dr. Fivenson says. “If you don’t recruit anyone, [the company] can pull the contract.”
Most drug companies push for competitive enrollment, meaning some sites can recruit more than others and get to keep them, he says. In the past year, Dr. Fivenson was the first site to fully enroll in two trials, and he also got the highest number of recruits in one study.
But that success has not been particularly easy to win. When he started his practice, Dr. Fivenson expected that as home to the University of Michigan, Ann Arbor would be an easy place to enroll study volunteers. Not so.
“Even though I can get advertising easier, this is an affluent community and there’s not enough motivation to participate. They’d rather just have their quality health care.”
What’s more, students aren’t typically the demographic of most studies. “Students are young, healthy people. They don’t have diseases like venous leg ulcers or bad psoriasis.”
Taking the First Step to Participation
Convinced clinical trials are for you but not sure what steps to take first? Dr. Fivenson recommends CenterWatch, an online search engine that lists tens of thousands of clinical trials funded by government and industry. In addition, some contract research organizations maintain their own registries. And, he adds, make sure to stay current on the developments in your specialty and communicate with the companies that are producing therapies in that area.
Most important, approach the work with the proper mindset. Dr. Dover, who has been conducting trials for 20 years, says making money shouldn’t be the prime mover. “We do them because of scientific curiosity. They’re fun, and they make practice that much more fun.”
Clinical trials help find new treatments that work, and can ensure that drugs are safe for patients. Clinical trials are also conducted to compare existing treatments to determine which are better, to determine if off-label uses of drugs are safe and effective, and to find the best ways to use standard treatments.
But how hard is it really to get involved in clinical trials? And should you do it?
While the answer may be yes for many doctors, most, evidently, are unconvinced. A 2004 survey by Health Care News found that 53% of practicing physicians said they had never participated in a clinical trial, while only 13% said they were running a study at the time. Doctors who didn’t conduct studies cited a lack of time, personnel, and resources, along with the burden of regulations, as the main reasons for not getting involved in research.
Surveys notwithstanding, interviews with dermatologists who participate in clinical research suggest that conducting studies can be professionally, intellectually, and, for some, financially rewarding.
“It allows you to give your patients cutting-edge treatment at a severely discounted price or for free,” says Dr. Mitchel Goldman, Medical Director of La Jolla Spa MD, in La Jolla, CA.
And, since according to Clinical-Trials.gov, there are 28,875 studies currently listed, opportunities are available. Of the 28,875 trials listed on the site, which is a service of the U.S. National Institutes of Health and developed by the National Library of Medicine, 12,430 are currently recruiting patients. According to the site, there are 49 trials recruiting patients for psoriasis trials, seven for acne vulgaris and 181 for melanoma.
“It’s exciting to be involved in the development of new products, and to be able to offer patients new options (for treatment),” echoes Steven R. Feldman, M.D., Ph.D., of Wake Forest University Baptist Medical Center in Winston-Salem, N.C. “Also, in an era where managed care is paying less for each office visit, you can charge your usual office rate” for patients enrolled in trials.
On the other hand, Dr. Goldman says, trials create their share of headaches. “It is a big responsibility and a potential financial drain on the practice.”
What You Need to Start Conducting Clinical Trials
For starters, any physician hoping to conduct regular trials will have to have dedicated — or, at the very least, specially trained — staff. La Jolla Spa has three full-time research nurses to handle the nine or so studies going on at any given time, Dr. Goldman says. The office also has separate exam rooms and filing systems to keep study patient records apart from those of regular office visitors.
Clinical trials are the raison d'être of academic medicine (along with teaching), so the infrastructure and support staff is already in place.
“I think a key advantage of an academic medical center is that they typically have lots of people well trained in FDA regulations and proper documentation,” says Joel M. Gelfand, M.D., Medical Director of the Clinical Studies Unit of the University of Pennsylvania’s Department of Dermatology. “The investigator has to have a very strong understanding of the federal regulations governing human subjects. And the regulations are as thick as a phone book.”
Dr. Gelfand has a master’s degree in epidemiology in addition to his M.D., giving him formal training into study design and research ethics. Study nurses in the unit also receive formal training in how to run studies properly, and are certified by a national body, the Society of Clinical Research Associates (SOCRA).
The dense bureaucracy, higher overhead costs, and lengthy institutional review board (IRB) process — intended to protect study subjects — are powerful incentives for drug companies to look off-campus for study centers. IRBs are a particularly glaring difference between academic and private settings. Universities typically send their study consent forms to local IRBs, made up of academics, religious and community representatives, and others; getting everyone to sign off of on the project can take several weeks.
Private practitioners have it easier, generally relying on national IRBs that are much more efficient (at the price, some might argue, of somewhat less sensitivity to the regional differences of study volunteers). The result is that private practice sites can start recruitment much more quickly than academic institutions.
However, private practice or not, hiring qualified staff and following all the regulations of the FDA and the drug study protocol are imperative. Not doing so can result in fines, exclusion from drug study participation or even loss of license. In fact, one dermatology practice in Pennsylvania used a clinical coordinator, who was not a physician, to examine research participants at various time intervals to measure the effectiveness of the drug being studied in the clinical trial — although the study protocol required the dermatologist to do the actual examinations. The data submitted back to the company that funded the study indicated that the study had been performed by the dermatologist. As this was not the case, the practice and the dermatologist involved were investigated. As part of a final plea agreement in this case, the practice was fined more than $100,000 and was required to pay restitution in the amount it had been paid to participate in the trial.
Start with What You Know
With anywhere from two to four clinical trials running at a time, Dr. Scott Gottlieb’s Exton, PA, office is a good example of a small practice that incorporates studies as a minority of its patient load. No more than about 5% of Dr. Gottlieb’s patients are enrolled in trials at any given time, he says.
“It really takes a big time commitment. There’s a lot of paperwork, a lot of hassle. I don’t think the financial reward is a reason to do it. You have to be interested in the topics you’re researching.”
In Dr. Gottlieb’s case, that’s psoriasis, so most of the trials he runs involve new therapies for that condition. He was able to use his contacts in the world of psoriasis research to land his first clinical trial, about 4 years ago. “I let it be known that I was interested. Once you get one, you can get others.”
Like most physicians, Dr. Gottlieb handles trials from Phase I, testing safety, through Phase IV, so-called “post-marketing” studies.
“I think it’s easiest doing Phase III and IV trials because you have the experience of the Phase I and II trials upon which to base your study. You already know a significant amount about potential side effects — and from a safety standpoint they’re probably a little safer to do.”
Still, the potential for unforeseen side effects always exists, Dr. Gottlieb says, so he makes himself available “24/7” to all his study subjects just as if they were his usual patients. (Drug companies should also have round-the-clock coverage, he adds.) However, he also includes his cell phone number on the consent form rather than the answering service number he provides other patients.
Spatial Relations
Even if you think you’ve got the time, resources and staff to take on trial patients, stop and ask yourself this: Can they all fit in my office?
“If you see 60 patients a day out of three or four exam rooms, and you want to start doing a substantial amount of clinical research work, you’ll need more space than what you have,” said Craig L. Leonardi, M.D., a St. Louis, MO, dermatologist.
In addition to accommodating additional staff and the endless stream of paperwork associated with trials, the office should have a comfortable place for research auditors — either from the company sponsor or the contract organization running the study — to sit when they comb through the records. Dr. Leonardi also warns that for many clinical trials the office will need an area for taking photographs.
“We have rooms with limited access where drugs and cameras are stored,” he says. “You might have a need for a -70˚F freezer and fridges that have to be locked at the end of the day.” Fortunately, Dr. Leonardi says, when he was hunting for office space he found a building with enough room. But for doctors already in practice the limits of their existing space will help determine how many trials they can run.
Dr. Leonardi has been conducting clinical trials out of his office since leaving his academic post at St. Louis University in 1999. He set up the practice with the intention of keeping it afloat with revenue from trials. In any given month he has between 12 to 15 studies running. By the end of this year, thanks to an acne trial with 60 patients, he’ll be seeing roughly 200 study participants under research protocols, representing about a quarter to half of his daily patient load.
Negotiating Contracts
While Dr. Leonardi was actively involved in research as an academic dermatologist, both at St. Louis University and the University of Miami, he had to learn about trials on the fly in private practice. One critical area he was unprepared for involved negotiating contracts with industry — something Dr. Leonardi says most doctors are “clueless” about.
“You have to be very careful when negotiating contracts,” he says. To be sure, the deal should be worth it for the clinician in dollars and time. “You get paid for what you do — exams, evaluations — and there’s a dollar amount affixed to every one of these things.”
Equally important, the document should be clear about liability. As in: the physician is free and clear of any claim against the company or the drug or device being tested. “Companies love to share that adventure with you, and you have to push back hard,” Dr. Leonardi quips.
Dr. Leonardi’s attorney reviews every contract he seriously considers, looking in particular for clauses that could land him major financial strain, or worse. And he’s not afraid to walk away from contracts that insist he assume a share of the liability — just as he has turned down contracts with unworkable budgets (he also has a consultant review study budgets for potential pots of red ink). “We’re a small private practice. We can’t be involved in indemnifying pharmaceutical companies,” Dr. Leonardi says.
On the other hand, Dr. Jeffrey Dover and his colleagues at SkinCare Physicians of Chestnut Hill, near Boston, occasionally take on money losing trials if they’re especially keen on the research question. “We can’t afford to do a whole bunch of studies in which we lose money, but we do them occasionally because we’re interested in the answer,” says Dr. Dover, who adds that most of the group’s studies involving lasers have been self-funded.
Recruitment, Recruitment, Recruitment
It’s certainly possible to make money running trials, and the lesson seems to be the more studies and subjects, the better the chances of being profitable.
But even the most enthusiastic investigator will fall flat without the most valuable commodity in clinical research: volunteers. The ability to recruit study subjects is key both to answering scientific questions and, for physicians, making trials pay for themselves.
“In private practice you can get up and running quicker than a university can, but if you don’t have access to a big enough pool of subjects, it can be a problem,” says Dr. David Fivenson, an Ann Arbor dermatologist who went into private practice after years of running clinical trials at Henry Ford Hospital in Detroit.
“On paper, by contract, I will have a couple hundred thousand dollars worth of trials by the end of the year. But whether I can accomplish that remains to be seen,” Dr. Fivenson says. “If you don’t recruit anyone, [the company] can pull the contract.”
Most drug companies push for competitive enrollment, meaning some sites can recruit more than others and get to keep them, he says. In the past year, Dr. Fivenson was the first site to fully enroll in two trials, and he also got the highest number of recruits in one study.
But that success has not been particularly easy to win. When he started his practice, Dr. Fivenson expected that as home to the University of Michigan, Ann Arbor would be an easy place to enroll study volunteers. Not so.
“Even though I can get advertising easier, this is an affluent community and there’s not enough motivation to participate. They’d rather just have their quality health care.”
What’s more, students aren’t typically the demographic of most studies. “Students are young, healthy people. They don’t have diseases like venous leg ulcers or bad psoriasis.”
Taking the First Step to Participation
Convinced clinical trials are for you but not sure what steps to take first? Dr. Fivenson recommends CenterWatch, an online search engine that lists tens of thousands of clinical trials funded by government and industry. In addition, some contract research organizations maintain their own registries. And, he adds, make sure to stay current on the developments in your specialty and communicate with the companies that are producing therapies in that area.
Most important, approach the work with the proper mindset. Dr. Dover, who has been conducting trials for 20 years, says making money shouldn’t be the prime mover. “We do them because of scientific curiosity. They’re fun, and they make practice that much more fun.”
