An Interview with Principal Investigator Dr. Rajesh Jain, M.D. Gastroenterologist, Rocky Mountain Gastroenterology
Dr. Rajesh Jain has been a practicing gastroenterologist since 1996. After completing his fellowship at the University of Cincinnati, Dr. Jain spent three years in private practice with a multi-specialty group in Iowa. In 1999, he joined Rocky Mountain Gastroenterology, where he has been an integral part of the team ever since. With nearly 28 years of experience, Dr. Jain is not only dedicated to providing exceptional patient care but also to advancing the field of gastroenterology through his active participation in clinical research.
How long have you been including research as part of your standard of care?
I’ve been involved in clinical research since 2000, so 24 years now. Initially, I became aware of it because my senior partners were already involved in clinical research and encouraged me to explore it. They mentioned it was an opportunity to be on the frontier of medicine, and that intrigued me. Typically, people think of research as something that is performed in academic centers only, such as universities. You don’t often associate private practice with cutting-edge research, but I realized this could allow me to offer something to my patients beyond available commercial treatments. When patients exhaust conventional medications, rather than sending them to a university where they might get lost in the academic system, I could provide access to clinical trials right here. This way, patients could stay with their doctor that they have an established relationship with while getting access to new treatments they otherwise wouldn’t. It’s been a win-win—patients benefit, often getting the latest medications for free, and I get to stay at the cutting edge of medicine.
What different types of clinical research models have you implemented?
Over the years, I’ve experimented with three different research models. Initially, my current practice, Rocky Mountain Gastroenterology, worked with a private research company in Denver. They handled negotiations with the sponsors and CRO’s and provided staffing for coordinators. We contracted with them to provide physician services, and that model worked well for about ten years. Eventually, we bought out the company when the CEO retired, thinking we could manage it internally. We tried to do everything ourselves—staffing, budget negotiations—but it was too much, and ultimately, it failed after 7-8 years due to billing issues and a lack of the right leadership, resulting in a major loss of revenue. We suspended research for a few years, especially during the pandemic. Then, one of my partners suggested we look into Topography, a company that provides the structure and framework for research while allowing us to focus on being doctors. That’s the model we’re using now, and it’s been a perfect fit.
What are some of the challenges physicians face when considering clinical research?
Several physicians in our group are hesitant to participate in trials. This stems from many issues; often it is due to a lack of experience and uncertainty about the unknown. Some worry about side effects of study medications or procedures. Others may not want to take the extra few minutes of their office visit to explain trials to patients. Still others may not understand the financial structure and benefit to their individual practices. In many cases though, less-involved physicians are willing to allow their patients to be recruited into trials, and these physicians receive a managing provider fee. For those who are interested but lack the experience, we often will start them off as sub-investigators and train up. This is where Topography has been particularly very helpful. Working together with the Principal Investigators, they slowly introduce the concepts and workflow to these interested physicians and eventually bring them up to speed so that we can have a steadily increasing pool of investigators, especially future Principal investigators.
How do you identify and select trials you want to participate in?
We have three main ways of getting trials. First, through Topography and their extensive network of contacts and relationships, who might hear about a trial and suggest our site in Denver. Second, some sponsors and CRO’s approach me about trials directly due to reputation. Third, we might hear about a trial through general advertising or word of mouth and decide to pursue it. When choosing a trial, the key factors include whether our patient population can support it and whether or not we have competing trials. It’s essential not to over-promise on patient enrollment because doing so can hurt our credibility. Additionally, I must be genuinely interested in the trial. If I’m not, I’d rather spend my energy elsewhere.
What’s one piece of advice you’d give a physician who is thinking about participating in their first trial?
My advice would be to manage expectations and be realistic about what you can deliver. I was involved in a study last summer that was at the tail end of its trial and needed the last 50 patients. We told them upfront that we might be able to enroll two to three patients in the next few months due to the stringent inclusion criteria and the nature of the disease. In the end, the trial closed, and we didn’t enroll anyone, but because we had been honest from the start, it didn’t reflect poorly on us. Experience and working with a company like Topography can help you gauge what’s feasible and negotiate appropriately.
Can you tell us more about the patient experience in clinical trials?
The patient experience varies depending on the disease state. For chronic illnesses like Crohn’s disease or ulcerative colitis, where there’s no cure, patients often are more willing to participate in a trial after failing multiple medications. They’re desperate for the next generation of treatment that might work for them. It’s gratifying to be part of the process when a drug you’ve been testing finally gets approved. As for patients, a lot depends on the trust they have in their physician. Patients I’ve worked with for years trust that I’m proposing a trial because I genuinely believe it could benefit them.
What types of trials excite you these days?
I’m particularly excited about trials related to gastroenterology, especially those involving inflammatory bowel disease and heartburn-related conditions. We’re also involved in a lot of liver disease trials within our group, though I’m not typically the Principal investigator on those. I prefer to stay within my areas of interest, but I’m always open to exploring new opportunities within GI and related fields.
