User login
Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research,
Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
Academic setting vs. private practice
Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.
Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
Finding a better treatment for C. difficile
For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.
The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.
To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.
Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.
SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.
In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.
The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.
Joining a practice that conducts clinical research
Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.
We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.
If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.
Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.
If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.
It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.
Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.
Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research,
Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
Academic setting vs. private practice
Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.
Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
Finding a better treatment for C. difficile
For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.
The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.
To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.
Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.
SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.
In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.
The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.
Joining a practice that conducts clinical research
Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.
We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.
If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.
Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.
If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.
It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.
Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.
Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research,
Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
Academic setting vs. private practice
Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.
Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
Finding a better treatment for C. difficile
For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.
The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.
To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.
Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.
SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.
In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.
The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.
Joining a practice that conducts clinical research
Within private practice settings, the opportunity to participate in clinical trials usually involves somewhat less bureaucracy and a more patient-centric approach. Private practitioners can also be selective in their research, and we only participate in a handful of selected trials that fit with the expertise of the providers in our practice.
We find the people best suited for involvement in pharmaceutical trials are those providers who want to participate in the scientific process and who see specialized patient populations with the diseases treated by the therapies being studied. In our experience, the young practitioner who enjoyed conducting research in fellowship, who attends national conferences, who keeps track of cutting-edge therapeutics within gastroenterology, and who is highly motivated will be successful in providing this service to their patients.
If you’re an early-career physician who would like to explore clinical research in private practice, there are a several things to look for when considering joining a practice.
Make sure the group has a support infrastructure and a clear compensation model for physicians who want to conduct research. Another important consideration is the kind of support staff the practice provides to manage clinical trials. Does the practice have physician and physician assistant subinvestigators and certified clinical research coordinators? It would be smart to research what kind of capabilities the practice has and inquire about what kind of commitment they have in terms of supporting research efforts.
If the practice you’re thinking of joining has a well-supported research program, you’ll soon be on the way to studying innovative treatments for a wide range of diseases affecting our communities, such as Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, celiac disease, and many others. Many practices also participate in trials assessing new technologies in endoscopy, such as capsule endoscopy of the colon.
It’s incredibly important for community practices to engage in studies and actively recruit younger physicians to participate in their research programs. It changes the character of the practice by bringing a certain level of scholarly activity that benefits the patients we serve, the field of gastroenterology, and medicine as a whole.
Dr. Feuerstadt is a practicing gastroenterologist at the PACT-Gastroenterology Center and is affiliated with Yale New Haven Hospital. Dr. Korman is codirector of Chevy Chase Clinical Research at Capital Digestive Care and a principal investigator in the Seres Therapeutics phase 3 ECOSPOR III study evaluating SER-109. Dr. Feuerstadt disclosed relationships with SERES Therapeutics, Ferring Rebiotix, Finch Therapeutics, and Merck. Dr. Korman disclosed a relationship with SERES Therapeutics.