Integrating Research into Community Practice – Towards Greater Diversity in Clinical Trials
The Covid-19 pandemic has highlighted health inequalities affecting racial and ethnic minorities and other underserved communities in the United States, highlighting, among other critical needs, the importance of increasing the diversity of participants in clinical tests. Clinical trials provide evidence for the safety and efficacy of medical products (or lack thereof). The ability of physicians to extrapolate trial results to their own patients would be greatly improved if the participants in a trial reflected as accurately as possible the patient population targeted by the product. Yet in 2020, industry-sponsored clinical trials that supported Food and Drug Administration (FDA) approval of new molecular entities and original therapeutic biologics included 8% of black or African American participants, 6 % Asians and 11% Hispanic or Latino participants.1
Many strategies have been developed to increase the enrollment of diverse populations, but they have produced mixed results. One strategy that has not been scaled up in a sustainable way is to involve community clinicians in research.
There is ample evidence that clinician recommendations play an important role in helping patients consider participating in clinical trials.2 However, such a commitment is not generalized. Multiple obstacles hinder the engagement of clinicians in research, starting with a lack of awareness and knowledge about clinical research. Many American clinicians are not affiliated with large academic medical centers or research institutes, and therefore may not be aware of ongoing research efforts, even if the research is being conducted at nearby sites. Other barriers are lack of time and remuneration to discuss trial participation with patients, failure to view clinical trials as part of the continuum of care, fears that participation may interfere with relationships established patient-clinician and lack of recognition to refer patients to trials. .2 Community clinicians typically do not receive the training, mentorship, ongoing support, and resources they need to enable sustained participation in research.
Lack of access to trials is a particularly problematic barrier for clinicians and patients. For example, less than 8% of cancer patients participate in clinical trials, although more than 50% will participate when given the opportunity.3 Community clinicians cannot present these opportunities to their patients if trials are not accessible.
Typical site selection practices create another significant hurdle: Often, in order to meet recruiting goals and deadlines, industry sponsors repeatedly use the same large sites and researchers to conduct clinical research. These sites and interviewers generally do not provide care to underserved populations and are often not easily accessible to various communities. Additionally, much US government-funded research is conducted in major medical centers, which may serve patients in their local communities but often does not engage community clinicians.
Engaging community clinicians in clinical research could have multiple benefits. These clinicians are dedicated to the populations they serve and are committed to solving the health problems of those populations. The trusting relationships established between clinicians and patients allow for transparency and open dialogue, as well as the sharing of knowledge about the benefits and risks of participating in the trial. The integration of community clinicians into the clinical research enterprise would also help address the accessibility challenges faced by patients: these clinicians are in the same neighborhoods as their patients, who could therefore face fewer difficulties in adjustment of working and transport schedules.
In addition, front-line clinicians have a lot to contribute to trial planning – for example, ensuring that trial logistics and enrollment criteria are achievable and do not create additional barriers. Recruiting community clinicians could also greatly expand the reach of clinical research by adding a large pool of potential participants, thereby reducing recruitment times, while increasing the likelihood that the trial population will resemble potential users of the products. Finally, expanding the pool of clinical researchers will facilitate the transposition of research results to clinical care.
How could such a change be accomplished? The challenges of clinical research during the current pandemic have been a wake-up call to proponents of government and industry trials. As tens of thousands of people fell ill and had to be hospitalized in American communities, many mainstream research sites faced competition for participants and slow enrollment, hampering the development of essential knowledge. Sponsors of clinical research, both public and private, increasingly recognize the need to expand the research base. Some initiatives to develop opportunities for non-traditional research sites are underway, including models that offer clinical trials and studies of providing care to people in their own communities.4.5 These models, however, have not been scaled up sustainably in all geographies.
Strong and ongoing funding, from public and private sources, will be required to provide community clinicians who wish to participate as investigators with the time, training, and financial and logistical support to do so. In places where these clinicians participate in a referral network, they will need continuing education on best practices to discuss clinical trials with patients; up-to-date information on trial opportunities for patients; support for patient education, decision-making and navigation translated into the languages spoken by their patients and adapted to their cultures; and assistance in the coordination of care. In addition, technological solutions that facilitate data collection and monitoring (e.g. remote or portable patient monitoring devices), improve the recruitment of demographically and geographically diverse populations, and reduce the burden of participation will need to be implemented. available. Such solutions currently exist but should be adapted to the needs of each community site.4.5
Now is the time for stakeholders in the clinical research ecosystem – the biomedical industry, policy makers, government agencies, contract research organizations, and patient advocates – to support long-term development and sustainability. end of an infrastructure that unites clinical research with clinical care. This investment will recognize that access to clinical research is essential to providing equitable health care to our diverse population. The FDA remains committed and will continue to work with all stakeholders to achieve this important goal.