As of April 2023, the number of recruiting studies in the US was 24,138. Based on FDA data from new drug approvals in 2021, we can assume an average of 760 patients are needed per study, meaning the number of patients necessary to fill currently recruiting clinical trials is approximately 18,344,880. Assuming every investigator sees an average of 100 patients per study, we would need an estimated 183,449 physicians to be involved as investigators in research.
Yet the FDA and NIH estimate that a mere 3% of both physicians and patients participate in clinical studies. This means only roughly 9,972,000 patients and 30,000 physicians are currently engaging in clinical research in the US. We must engage, train and support more physicians as investigators to enable the opportunity for their patients to have access to clinical trials.
Many sponsors desire seasoned investigators to run these trials—they may require physicians to have a set number of years of experience or experience in specific indications as a requirement to be an investigator on the trial. This presents a dilemma to the industry—if one does not have experience, how can one participate? With this model, it will be exceedingly difficult, if not impossible, to meet industry demands. It is an absolute necessity that drug and device makers consider less experienced investigators to fulfill current and future trial needs and that we as an industry find these emerging investigators, train them, and provide them with the opportunity to participate in research.
The right investigators
By far, the most important quality in an investigator is a patient care-centered focus. These are individuals who are committed to considering all possible avenues for their patients’ care. In other words, they are open to CRAACO, clinical research as a care option. It comes down to their curiosity and willingness to expand their horizons beyond their routine practice. Of course, physicians can make additional money participating in research, but that cannot and should not be the central motivating factor. They must believe in the intrinsic value of clinical research as an important and viable care option for their patients.
Diversity of patient populations is essential in clinical research. A larger, more diverse pool of investigators allows sponsors to tap into specific groups that are more representative of the demographic composition of the United States. Recent FDA guidance on this topic notes that “adequate representation in clinical trial(s) and studies supporting regulatory submissions helps ensure that the data generated in the development program reflects the racial and ethnic diversity of the intended use population for the medical product, if approved, and may potentially identify safety or efficacy outcomes that may be associated with, or occurring more frequently, within these populations.”
To meet this crucial imperative, industry must avoid bias when it comes to considering new investigators as that is how trials can extend into communities where the patient need truly exists. This entails a strategy that also embraces geographic diversity. Considering investigators from different regions—rural, suburban, urban—provides deeper access to a diversity of patients within those varied communities. We have seen that the race or ethnicity of an investigator does not always guarantee a patient population of the same race or ethnicity. Seeking out investigators embedded within racially and ethnically diverse communities will help industry reach underserved populations. It is important to note that those communities may not always be close to large academic medical centers or practices where established investigators practice. Our industry must be more open-minded to expanding to new geographic locations in order to broaden the reach of clinical research as a care option for patients.
The right support system
Oversight of a clinical trial is undoubtedly hard work. It can be overwhelming to physicians if they are managing personnel, clinic schedules, regulatory aspects, and the financial implications of research. Partners such as CROs and, more extensively, IROs exist to facilitate and support the entire process, taking much of the burden off investigators. Certainly, physicians are still very much responsible for the conduct and the execution of the study, but the partner provides comprehensive training, so investigators clearly understand their responsibilities versus those of the research team, enabling their success. Without the proper support system, history has shown more than half of investigators choose not to participate again after only one trial.
Removing barriers to entry for new investigators is key. One way to do this is through a comprehensive onboarding process that includes a blend of necessary documentation and training to ensure all investigators are properly credentialed and equipped to lead clinical research. Investing in the investigators by maintaining communication, providing recognition, facilitating development, and soliciting feedback strengthens the relationship and ensures they stay engaged.
Overcoming sponsor bias is also a significant obstacle faced by emerging investigators. Confirmation of having had prior clinical research experience, regardless of past performance, is often the most important box that sponsors and CROs look to check when considering an investigator. When leveraging investigators who are newer to trials, a way to counter this question can be with a “no, but…” response, stressing a physician’s medical or clinical expertise, number of years in practice, and access to untapped patient populations. Although sponsor bias remains a persistent hurdle, we can chip away at outdated perceptions and open the door to award more trials to experienced and passionate physicians, irrespective of past trial experience.
In order for clinical trials to achieve the physician and patient involvement needed to advance CRAACO, we know we have to pivot. Not tomorrow, but today. We must make sure we are finding passionate physicians and giving them the right tools to be successful as investigators. As an industry, we should be adding anywhere from 10% to 20% new investigators every year to meet the patient access needs for clinical trials. Under the weight and restrictive expectations of our current system, this growth and advancement is not obtainable. It is time to work together for change.
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