Alliance for Representative
Ethnically and racially diverse audiences are underrepresented in clinical trials.
National Minority Quality Forum (NMQF) has launched the Alliance for Representative Clinical Trials (ARC). ARC is a multi-sponsor public/private program organized to diversify and bring clinical trials to communities of color and other communities that have been underrepresented in clinical trials.
ARC has two distinct but related programs:
1) The PI Institute that trains community clinicians to be clinical trial principal investigators (PIs)
2) Clinical Investigative Site Network (CISN), which conducts sponsored clinical trials through a network of PI Institute graduates
In this site, ARC explores:
A Look Into Disparities
Caucasians make up 68% of the U.S. population but are 93.4% of research participants.
Black/African Americans make up 13.6% of the U.S. population, but only 5.6% of trial participants.
Hispanic/Latinos represent 18.4% of the U.S. population, but are 1% of the trial.
A Need For Change
ARC was launched to create a network of community clinicians that is organized to diversify and bring clinical trials to communities of color and other communities that have been underrepresented in clinical trials.
This collaborative effort allows for a significant sample size of the minority population to be included in clinical trials by including community clinic participation, thus providing sufficient power for drawing meaningful conclusions that would otherwise exclude minorities and not account for their health outcomes.
In a recent article in the New England Journal of Medicine, the U.S. Food and Drug Administration and NMQF wrote jointly that “The time has come for stakeholders in the clinical research ecosystem — the biomedical industry, policymakers, government agencies, contract research organizations, and patient advocates” — to join together to support “the development and long-term sustainability of an infrastructure that unites clinical research with clinical care”. They noted that “Many strategies have been developed to increase enrollment of diverse populations, but they have produced mixed results. One strategy that has not been scaled up in a sustainable way is engaging community clinicians in research”. Industry sponsors, they observed, “repeatedly use the same large sites and investigators to conduct clinical research. These sites and investigators generally do not provide care to underserved populations and are often not easily accessible to diverse communities”. Trials sponsored by the U.S. government are conducted at major medical centers, which may serve patients in their local communities but often do not engage community-based clinicians.
ARC was launched to address the need to unite clinical research with clinical care while increasing diversity in clinical trials. Community clinicians who wish to join ARC as investigators will need to be resourced so they have the time, training, and financial and logistic support to do so. In places where community clinicians act as a referral network, they will require ongoing training in best practices for discussing clinical trials with patients; up-to-date information about trial opportunities for patients; support for patient education, decision making and navigation translated into the languages spoken by their patients and tailored to their cultures; and assistance with care coordination. In addition, technology solutions that facilitate data collection and monitoring (e.g., remote or wearable patient monitoring devices), enhance enrollment of demographically and geographically diverse populations, and reduce the burden of participation will need to be constantly upgraded.
NMQF invites community clinicians to enroll in the PI Institute where they attend a thirteen-hour course conducted by a leading global contract research organization (CRO) (providing comprehensive, integrated drug development, laboratory, and lifecycle management services). As a part of the training, NMQF will issue a site feasibility survey to determine what, if any, upgrades (human and physical) are required to organize the clinician practice as a clinical research site.
Upon successful completion of PI training, the Institute will issue a certification that a community clinician (and the practice site) has met its standards to be a PI. The institute will offer programs and recertification to ensure that its network of investigators remains in compliance with best clinical trial standards.
Upon completion of the PI Institute training course, investigators and the clinics in which they conduct business will be eligible to join the Clinical Investigative Site Network (CISN). Under the umbrella of ARC, serving as a single entity representing the network sites, CISN liaises with sponsors, as well as streamlines and coordinates all clinical trial activities. Furthermore, CISN refines clinical trial processes to ensure optimally performed trials, using a centralized IRB, single contracting, budgeting, Informed Consent Form processing, and more, via a centralized study activation center.
As an investigator in ARC, you will gain experience in multi-institutional research projects in a variety of therapeutic branches of medicine, including oncology. Investigators will receive a range of training, services, research-specific accreditation, operational and equipment upgrades to their site as needed, and continuous monitoring support to strengthen their ability to operate as a clinical trial site at no cost to the investigator or clinic. Ultimately, generating new direct and indirect revenue streams for your clinic.
Sponsors will gain access to a network of well-managed, trial-ready sites in local communities run by community clinicians that will have the capacity to enroll participants that have been underrepresented and underserved. Sponsors not only get the availability of vetted sites making for a simplified site selection process but they are also afforded an added layer of quality management, improved coordination among sites and timely trial onboarding.
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