We recently passed Crohn’s and Ulcerative Colitis Awareness Week (December 1-7, 2020) and Clinical Research IO was interested in learning more about clinical research in gastroenterology. We connected with Gerry Glazer, Henika Lobo, and Dr. Michael Gould of TDDA Specialty Research (TDDA) to gain insight into conducting GI research.
Can you tell us how TDDA Specialty Research (TDDA) came together?
Dr. Gould: In the beginning, doing clinical research for disease entities in gastroenterology wasn’t easy. Most of the GI research was being conducted in hospitals. The inception of our clinical research organization, TDDA, coincides with when many hospitals in Toronto were undergoing reorganization. Dr. Theadore Ptak, Dr. Jeffrey Axler, and I thought that if we could get everyone in the Western Greater Toronto Area together, we would be able to protect GI care and research.
We went from one trial to too many very quickly. We started with an intravenous proton pump inhibitor (IV PPI) trial and soon realized how successful GI research could be. However, it would be extremely difficult to do so in a hospital environment as there were many challenges in meeting our required timelines. Soon after, we moved into our own space and built an endoscopy site within our office.
Since then, we have been quite successful in attracting trials in all aspects of GI research as well as studies in hepatology, dermatology, and rheumatology. With a core group of 11 gastroenterology doctors, our site became known for successful high-quality GI research.
Can you tell us about the nature of GI diseases, specifically Crohn’s and Ulcerative Colitis?
Dr. Gould: Crohn’s and ulcerative colitis can be thought of as cousins and attract mostly the same drugs. Both are considered chronic autoimmune, inflammatory diseases of the bowel that have both genetic and environmental components. Although neither are considered terminal, they can be debilitating. Individuals with Crohn’s or Ulcerative Colitis most commonly present with symptoms between the ages of 18-30, but they may present earlier or later.
What is the current standard of care?
Dr. Gould: The standard of care used to be steroids and surgery, but now it is the use of biological medications. The majority of people who elect to go into trials have either failed an approved drug or have reimbursement issues with acquiring approved drugs. Others participate because they are interested in a new mechanism of delivery or want to contribute to ongoing research.
Once patients are enrolled in a trial, the care that they receive is exceptional. The frequency of visits, relationships with coordinators and doctors is truly on another level. In the end, long-term health outcomes are better than just the drug itself.
What is the average number of patients enrolled in an IBD study?
Ms. Lobo: For most IBD trials, there are anywhere between 250 to 600 participants recruited globally. At our sites, we typically enroll upwards of 30+ patients per trial per site. We have over 40 ongoing studies, but still, there are a significant number of people not engaged in studies and so we see the ability to expand our reach.
In addition to doing GI research, TDDA has tackled trials in other therapeutic areas. What is unique about conducting an IBD trial when compared to a trial in a different field?
Dr. Gould: The required procedures involved in GI research include endoscopies. The majority of trials investigating biologics for other inflammatory diseases in dermatology, rheumatology, and ophthalmology usually do not require such procedures.
What are the key success factors for doing GI research?
Dr. Gould: There are many things that will make a site successful in GI research, but there are 3 critical factors.
1) Having the space and sites to do necessary procedures. The larger the hospital or healthcare institution, the more rigid the procedures/regulations are and the more difficult it is to do things. This is what led us to break away from that environment.
2) Work with a central IRB rather than an internal IRB.
3) Have the appropriate staff and team complete all procedures appropriately and efficiently. GI trials involve large amounts of information, patient data, and details. You need a good team to keep a good workflow.
What are the biggest challenges with conducting a Crohn’s or Ulcerative Colitis trial?
Dr. Gould: One of the earliest challenges in GI research is identifying a trial that a sick patient will fit the criteria for, but is also appropriate for the patient. Trials are very specific and often want to recruit individuals that are sick, but not too sick. As a result, management of the screening process and progression of an individual’s disease can be difficult. As such, having multiple trials with different eligibility criteria is helpful because the chances that the patient will fit at least one trial increases.
Not unique to GI research is the placebo arm of a trial. If a sick individual is placed on the placebo arm, there can be anywhere from 8 to 12 weeks of placebo before they receive the investigational product. During this time of delayed treatment, physicians must carefully navigate patients through the placebo arm, which can be very challenging.
Were your IBD trials significantly impacted by COVID?
Dr. Gould: When COVID started in March 2020, we had to close down our endoscopy unit and it remained closed until May. Consequently, we weren’t allowed to enter any new patients until July 2020. As there was some allowance for virtual medicine, we were able to continue providing care for patients already enrolled.
Ms. Lobo: Most of our ongoing trials are global trials, so we understand that it was challenging for sponsors to manage trials sites and organizations around the world. For sponsors that we’re able to make changes such as incorporating the use of online assessments or bypassing certain procedures, we continued to see patients. Our sites remained reactive and proactive and did their best to help other sponsors that weren’t able to adapt as quickly.
Do you feel that using an electronic source and CTMS system is helpful in conducting IBD research?
Mr. Glazer: Being able to formalize data collection and site processes in a compliant electronic environment is definitely helpful. Having a system that has remote monitoring or eRegulatory capabilities is especially important in the current research atmosphere. It allows for increased oversight and many pharmaceutical groups have recognized the need to adopt such technologies.
What advice do you have for sites interested in getting involved in IBD research?
Dr. Gould: You must have staff that are interested in GI research and doctors that understand and want to benefit from looking after patients in a different way. Consider recruiting a core group of physicians that are specialists in the GI field. Additionally, your practice must have enough patients who want to get involved in research. Finally, bring GI research opportunities to people and places that need them, never had them and want the opportunity to engage and benefit from the research itself.
Where do you see GI research in the future?
TDDA: Research will become a part of the patient care strategy. In terms of treatments, who knows where the next turn will be. We don’t know what is coming next, but we are waiting for the next boom and we are ready to capture it.
TDDA Specialty Research (TDDA) is a clinical research organization in Vaughan, Ontario that conducts clinical trials in gastroenterology, hepatology, dermatology, and other fields. Since its inception in 1999, TDDA has become an established leader in clinical research and has completed over 200 Phase II, III and IV research projects. As TDDA hopes to continue expanding, they strive to offer physicians and patients access to leading treatment options.