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Clinical research in private practice? It can be done, and here’s how
Not every physician coming out of medical school wants to go down the path of conducting clinical research. But for those who do, the decision is a rewarding one that can make a real difference in patients’ lives.
I took a nontraditional route to get to my current role as the director of clinical research and education at the largest gastroenterology practice in the United States. I had a business degree coming out of college and worked for years in the business world prior to going to medical school. After graduation, I got an offer to join the pharmaceutical industry in medical affairs. There, I focused on inflammatory bowel disease (IBD), where my role was to share high-level scientific data and liaise with IBD disease state experts. Part of the role was working internally with clinical operations and externally with sites conducting research throughout the United States. In the next 6 years, I had the opportunity to observe how research was run in both the academic and community practice settings, noting those characteristics that allowed some to succeed and far more to stagnate or fail.
In 2014, I joined Texas Digestive Disease Consultants with the goal to ramp up the practice’s clinical research arm and create a department expressly for that purpose. To date, the department has become incredibly successful and ultimately sustainable. If you’re considering joining a practice based on its clinical research program or starting one in your current practice, here is what I’ve learned along the way:
Know the benefit to patients
You have to decide to conduct clinical research because of its benefit to the patient, not because you see it as an alternative revenue stream. It will never be sustainable if viewed as a profit center. Clinical research offers therapeutic advancements that will not be available to most for the next 5-10 years. Additionally, patients do not need insurance in order to participate in a study. The sponsor covers all study visits, procedures, and therapeutics.
Know the value to the practice
Having a clinical trials program brings both direct and indirect enterprise value to the practice. It may come in the form of referrals from other practices that don’t have the same capabilities. Patients may view your practice differently, knowing that it has the added value of research. There is a halo effect from having clinical trials capabilities in how you are viewed by patients and other physicians in the community.
Get the right people in place
First, you will need an enthusiastic primary investigator who can take a bit of time from practice to conduct clinical trials. But just as importantly, you need a knowledgeable clinical research coordinator. Without an effective coordinator, the program is doomed. A good coordinator should be well rounded in all aspects of research (e.g., regulatory, patient recruitment, quality assurance, contracts, budgets, running labs, conducting patient visits) and able to deal with the day-to-day intricacies of running clinical trials, which will allow a doctor to take care of the existing practice. They should also be versed in the requisite equipment (e.g., locking refrigerator, freezer, and ambient cabinet, temperature monitoring devices, EKG machine, and centrifuge) necessary to run a clinical study.
Know how to recruit patients
The database at Texas Digestive Disease Consultants/GI Alliance (TDDC/GIA) is vast, which makes identification of patients who may qualify for a trial an easier task. Many practices will have an electronic medical record that will aid in identification, but if that is not the case at your practice, there are a number of ways you can go about this. First, talk to physicians in your practice and in other practices – internists, family physicians, and other gastroenterologists come to mind – about what you can offer. Send a letter or an email out to physicians in the community with the inclusion/exclusion criteria for your study, and always direct them to https://clinicaltrials.gov/ for additional information. Patient advocacy organizations are another good source of referrals for clinical trials. And of course, pharmaceutical companies have recruitment services that they use and can help steer patients your way.
Understand the ethics
There are numerous ethical and legal considerations when it comes to running clinical trials. The principles of Good Clinical Practice (GCP) and Human Subject Protection (HSP) guide the conduct of clinical trials in the United States. Understanding the concepts and regulations around caring for patients in trials is not only “good practice,” it’s a necessity. There are free Good Clinical Practice training courses available, which are required every few years for everyone conducting clinical research. These courses are quite lengthy (3-6 hours), but provide a great overview of the Food and Drug Administration regulations, ethical considerations, and other advice on successfully operating a clinical trials program. Again, a capable clinical research coordinator will help guide you here.
Adopt standard operating procedures
Every clinical trials sponsor will require standard operating procedures for such facets of research as informed consent, reporting requirements, and safety monitoring. Here again, a seasoned clinical trials coordinator can put you on the right path. You may choose to purchase standardized templates or work with another group that already has them and would be willing to share.
Be smart about spending
While this may depend on the scale you want to grow your research, at TDDC/GIA we knew we wanted to build a sustainable program. We invested a lot of time and money into our infrastructure, as well as adopting a robust Clinical Trials Management System (CTMS). A CTMS system will provide the ability to measure productivity, finances, schedule patient visits, and pay patient stipends. Some systems even automate the regulatory process (E-Regulatory) or source process (E-source), which can cut down on the paper burden on a site.
Seek mentors
Look for someone to emulate who is already established in operating a clinical research program in private practice. Reach out to the practices or physicians that are already doing this work and doing it well. For physicians who are just starting out or still in training, look for opportunities to publish or be involved with the clinical trials program at your institution.
Contacts in the pharmaceutical industry are very important to getting a new program off the ground. Ask the pharma sales representatives who visit your clinic to put you in touch with their medical science liaison (MSL). The MSL can get you information about the clinical trials their company is currently running and those they have in the pipeline.
Dr. Chris Fourment, director of clinical research and education, Texas Digestive Disease Consultants/GI Alliance.
Not every physician coming out of medical school wants to go down the path of conducting clinical research. But for those who do, the decision is a rewarding one that can make a real difference in patients’ lives.
I took a nontraditional route to get to my current role as the director of clinical research and education at the largest gastroenterology practice in the United States. I had a business degree coming out of college and worked for years in the business world prior to going to medical school. After graduation, I got an offer to join the pharmaceutical industry in medical affairs. There, I focused on inflammatory bowel disease (IBD), where my role was to share high-level scientific data and liaise with IBD disease state experts. Part of the role was working internally with clinical operations and externally with sites conducting research throughout the United States. In the next 6 years, I had the opportunity to observe how research was run in both the academic and community practice settings, noting those characteristics that allowed some to succeed and far more to stagnate or fail.
In 2014, I joined Texas Digestive Disease Consultants with the goal to ramp up the practice’s clinical research arm and create a department expressly for that purpose. To date, the department has become incredibly successful and ultimately sustainable. If you’re considering joining a practice based on its clinical research program or starting one in your current practice, here is what I’ve learned along the way:
Know the benefit to patients
You have to decide to conduct clinical research because of its benefit to the patient, not because you see it as an alternative revenue stream. It will never be sustainable if viewed as a profit center. Clinical research offers therapeutic advancements that will not be available to most for the next 5-10 years. Additionally, patients do not need insurance in order to participate in a study. The sponsor covers all study visits, procedures, and therapeutics.
Know the value to the practice
Having a clinical trials program brings both direct and indirect enterprise value to the practice. It may come in the form of referrals from other practices that don’t have the same capabilities. Patients may view your practice differently, knowing that it has the added value of research. There is a halo effect from having clinical trials capabilities in how you are viewed by patients and other physicians in the community.
Get the right people in place
First, you will need an enthusiastic primary investigator who can take a bit of time from practice to conduct clinical trials. But just as importantly, you need a knowledgeable clinical research coordinator. Without an effective coordinator, the program is doomed. A good coordinator should be well rounded in all aspects of research (e.g., regulatory, patient recruitment, quality assurance, contracts, budgets, running labs, conducting patient visits) and able to deal with the day-to-day intricacies of running clinical trials, which will allow a doctor to take care of the existing practice. They should also be versed in the requisite equipment (e.g., locking refrigerator, freezer, and ambient cabinet, temperature monitoring devices, EKG machine, and centrifuge) necessary to run a clinical study.
Know how to recruit patients
The database at Texas Digestive Disease Consultants/GI Alliance (TDDC/GIA) is vast, which makes identification of patients who may qualify for a trial an easier task. Many practices will have an electronic medical record that will aid in identification, but if that is not the case at your practice, there are a number of ways you can go about this. First, talk to physicians in your practice and in other practices – internists, family physicians, and other gastroenterologists come to mind – about what you can offer. Send a letter or an email out to physicians in the community with the inclusion/exclusion criteria for your study, and always direct them to https://clinicaltrials.gov/ for additional information. Patient advocacy organizations are another good source of referrals for clinical trials. And of course, pharmaceutical companies have recruitment services that they use and can help steer patients your way.
Understand the ethics
There are numerous ethical and legal considerations when it comes to running clinical trials. The principles of Good Clinical Practice (GCP) and Human Subject Protection (HSP) guide the conduct of clinical trials in the United States. Understanding the concepts and regulations around caring for patients in trials is not only “good practice,” it’s a necessity. There are free Good Clinical Practice training courses available, which are required every few years for everyone conducting clinical research. These courses are quite lengthy (3-6 hours), but provide a great overview of the Food and Drug Administration regulations, ethical considerations, and other advice on successfully operating a clinical trials program. Again, a capable clinical research coordinator will help guide you here.
Adopt standard operating procedures
Every clinical trials sponsor will require standard operating procedures for such facets of research as informed consent, reporting requirements, and safety monitoring. Here again, a seasoned clinical trials coordinator can put you on the right path. You may choose to purchase standardized templates or work with another group that already has them and would be willing to share.
Be smart about spending
While this may depend on the scale you want to grow your research, at TDDC/GIA we knew we wanted to build a sustainable program. We invested a lot of time and money into our infrastructure, as well as adopting a robust Clinical Trials Management System (CTMS). A CTMS system will provide the ability to measure productivity, finances, schedule patient visits, and pay patient stipends. Some systems even automate the regulatory process (E-Regulatory) or source process (E-source), which can cut down on the paper burden on a site.
Seek mentors
Look for someone to emulate who is already established in operating a clinical research program in private practice. Reach out to the practices or physicians that are already doing this work and doing it well. For physicians who are just starting out or still in training, look for opportunities to publish or be involved with the clinical trials program at your institution.
Contacts in the pharmaceutical industry are very important to getting a new program off the ground. Ask the pharma sales representatives who visit your clinic to put you in touch with their medical science liaison (MSL). The MSL can get you information about the clinical trials their company is currently running and those they have in the pipeline.
Dr. Chris Fourment, director of clinical research and education, Texas Digestive Disease Consultants/GI Alliance.
Not every physician coming out of medical school wants to go down the path of conducting clinical research. But for those who do, the decision is a rewarding one that can make a real difference in patients’ lives.
I took a nontraditional route to get to my current role as the director of clinical research and education at the largest gastroenterology practice in the United States. I had a business degree coming out of college and worked for years in the business world prior to going to medical school. After graduation, I got an offer to join the pharmaceutical industry in medical affairs. There, I focused on inflammatory bowel disease (IBD), where my role was to share high-level scientific data and liaise with IBD disease state experts. Part of the role was working internally with clinical operations and externally with sites conducting research throughout the United States. In the next 6 years, I had the opportunity to observe how research was run in both the academic and community practice settings, noting those characteristics that allowed some to succeed and far more to stagnate or fail.
In 2014, I joined Texas Digestive Disease Consultants with the goal to ramp up the practice’s clinical research arm and create a department expressly for that purpose. To date, the department has become incredibly successful and ultimately sustainable. If you’re considering joining a practice based on its clinical research program or starting one in your current practice, here is what I’ve learned along the way:
Know the benefit to patients
You have to decide to conduct clinical research because of its benefit to the patient, not because you see it as an alternative revenue stream. It will never be sustainable if viewed as a profit center. Clinical research offers therapeutic advancements that will not be available to most for the next 5-10 years. Additionally, patients do not need insurance in order to participate in a study. The sponsor covers all study visits, procedures, and therapeutics.
Know the value to the practice
Having a clinical trials program brings both direct and indirect enterprise value to the practice. It may come in the form of referrals from other practices that don’t have the same capabilities. Patients may view your practice differently, knowing that it has the added value of research. There is a halo effect from having clinical trials capabilities in how you are viewed by patients and other physicians in the community.
Get the right people in place
First, you will need an enthusiastic primary investigator who can take a bit of time from practice to conduct clinical trials. But just as importantly, you need a knowledgeable clinical research coordinator. Without an effective coordinator, the program is doomed. A good coordinator should be well rounded in all aspects of research (e.g., regulatory, patient recruitment, quality assurance, contracts, budgets, running labs, conducting patient visits) and able to deal with the day-to-day intricacies of running clinical trials, which will allow a doctor to take care of the existing practice. They should also be versed in the requisite equipment (e.g., locking refrigerator, freezer, and ambient cabinet, temperature monitoring devices, EKG machine, and centrifuge) necessary to run a clinical study.
Know how to recruit patients
The database at Texas Digestive Disease Consultants/GI Alliance (TDDC/GIA) is vast, which makes identification of patients who may qualify for a trial an easier task. Many practices will have an electronic medical record that will aid in identification, but if that is not the case at your practice, there are a number of ways you can go about this. First, talk to physicians in your practice and in other practices – internists, family physicians, and other gastroenterologists come to mind – about what you can offer. Send a letter or an email out to physicians in the community with the inclusion/exclusion criteria for your study, and always direct them to https://clinicaltrials.gov/ for additional information. Patient advocacy organizations are another good source of referrals for clinical trials. And of course, pharmaceutical companies have recruitment services that they use and can help steer patients your way.
Understand the ethics
There are numerous ethical and legal considerations when it comes to running clinical trials. The principles of Good Clinical Practice (GCP) and Human Subject Protection (HSP) guide the conduct of clinical trials in the United States. Understanding the concepts and regulations around caring for patients in trials is not only “good practice,” it’s a necessity. There are free Good Clinical Practice training courses available, which are required every few years for everyone conducting clinical research. These courses are quite lengthy (3-6 hours), but provide a great overview of the Food and Drug Administration regulations, ethical considerations, and other advice on successfully operating a clinical trials program. Again, a capable clinical research coordinator will help guide you here.
Adopt standard operating procedures
Every clinical trials sponsor will require standard operating procedures for such facets of research as informed consent, reporting requirements, and safety monitoring. Here again, a seasoned clinical trials coordinator can put you on the right path. You may choose to purchase standardized templates or work with another group that already has them and would be willing to share.
Be smart about spending
While this may depend on the scale you want to grow your research, at TDDC/GIA we knew we wanted to build a sustainable program. We invested a lot of time and money into our infrastructure, as well as adopting a robust Clinical Trials Management System (CTMS). A CTMS system will provide the ability to measure productivity, finances, schedule patient visits, and pay patient stipends. Some systems even automate the regulatory process (E-Regulatory) or source process (E-source), which can cut down on the paper burden on a site.
Seek mentors
Look for someone to emulate who is already established in operating a clinical research program in private practice. Reach out to the practices or physicians that are already doing this work and doing it well. For physicians who are just starting out or still in training, look for opportunities to publish or be involved with the clinical trials program at your institution.
Contacts in the pharmaceutical industry are very important to getting a new program off the ground. Ask the pharma sales representatives who visit your clinic to put you in touch with their medical science liaison (MSL). The MSL can get you information about the clinical trials their company is currently running and those they have in the pipeline.
Dr. Chris Fourment, director of clinical research and education, Texas Digestive Disease Consultants/GI Alliance.