With Guest Carlos E. Orantes
Christine Senn:
A serious issue facing the clinical research industry – forecasted to become a crisis – is the lack of investigators. Denise Snyder said that it isn't that bad at academic medical centers (AMCs) because research is often part of the job at university hospitals. However, many view it as a frightening reality at independent sites. What do you think the industry can do to help, since medical schools don't stress the importance of clinical research, which is vital for developing new medicines?
Carlos Orantes:
It's interesting to hear that medical schools don't emphasize the importance of clinical research. I have a story about a class president from a Midwestern university who was intrigued by clinical research. He asked me to present on drug development and clinical research. I prepared several outlines for his committee, but the committee rejected it, citing a potential conflict of interest. This suggests that medical schools are either oblivious to or blocking clinical research education. We, as an industry, need to figure out a way to address this, whether through pharma or the FDA. The bigger issue is the dwindling pool of investigators in our industry, a trend also seen in veterinary and preclinical nonclinical research. We must anticipate the industry's needs and take short-term and long-term actions to mitigate this problem.
Christine Senn:
Your idea of involving a larger body in this issue is important. I was hopeful about integrating clinical research into medical school education. Having started in oncology 18-20 years ago, I observed that clinical research was integral to the training of oncologists. Now, it seems even oncologists are less involved in clinical research. Physicians and medical schools, with limited time, are excluding crucial elements like clinical research from their curricula. We’ve approached community physicians about participating in clinical trials, like for rivaroxaban, but many declined. Yet, when the drug was approved, they were among the first to prescribe it. This seems like cognitive dissonance, doesn't it?
Carlos Orantes:
The interesting thing, Christine, is that we work with medical practices in various ways. They see the value of clinical research not only in offering additional treatment options to their patients but also as a way to monetize their time and involvement. Moreover, they believe they can attract new talent into their practices by showing their involvement in research. These physicians, who went through med schools and are now in practice, want to get into research for various reasons. So, there's an opportunity to create an initiative, starting small with some med schools and then expanding. There's a perception that pharma has a conflict of interest in clinical research. However, it's the FDA that requires this testing, not the pharmaceutical companies. In the meantime, we're taking the initiative and reaching out to the community, finding research-naive physicians, and training them properly within Alcanza. This approach has significantly improved the experience for new investigators.
Christine Senn:
I love it. It's essential to have training programs for site staff to support new investigators. Site staff, being experts in clinical research, are crucial in training physicians who are not yet experts in clinical research.
Carlos Orantes:
Indeed. Physicians need training not only as investigators but also in how to train coordinators and research assistants. It's a symbiotic relationship. The better we train, the better the experience for patients and the team dynamics at research sites. Companies need to recognize this problem and develop both short-term and long-term actions to address it.
Christine Senn:
Extremely well said. Thank you.