Initially launched in 2016, the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) brought together researchers, clinicians, and lawyers across Yale University with the goal to enhance the quality and transparency of the research base for medical products. During its first tenure, formerly known as the Yale Collaboration for Research Integrity and Transparency (CRIT) successfully pursued several research, advocacy, and litigation projects towards ensuring that clinical evidence supporting and informing the collective understanding of the safety and efficacy of drugs, medical devices, and other health products is accurate, comprehensive, accessible, and reliable. A full overview of the many activities and accomplishments of Yale CRIT can be found here. If you need more guidance, please refer to the webpage mockup attached under About Us
However, ambiguities and inconsistencies in standards for evaluating evidence and obtaining market approval for drugs, devices, and other medical products regulated by the FDA have continued to raise concerns about the downstream consequences of such approvals on other healthcare stakeholders including patients, clinicians, and payors. The evidence base for FDA approval has weakened over time – leading patients and clinicians to make medical product decisions with greater uncertainty. Fewer medical products receive FDA approval based on more than one pivotal clinical trial or are tested against an active comparator drug. Moreover, indications for drugs and biologics are increasingly approved through special regulatory pathways or designations. These special programs have also been associated with more flexible standards for approval, fewer patients enrolled into pivotal clinical trials, and shorter clinical trial durations. Further compounding uncertainty of the efficacy and safety of medical products is the continued failure of sponsors to publicly report clinical trial results to ClinicalTrials.gov, even when legally mandated to do so.
Further empiric research, regulatory policy analysis, and development of alternative strategies are urgently needed to ensure transparency and integrity of the clinical evidence base supporting approval of new medical products. Bringing together experts across disciplines, including meta-research, bioethics, regulatory science and law, and federal and commercial insurance coverage, the newly formed Yale CRRIT conducts targeted research to inform policies that support a more robust evidence base for FDA-regulated medical products, and to evaluate regulatory enforcement and transparency of current policies.
Yale CRRIT also brings its collective strengths of disseminating and translating research results towards actionable policy change. This will include direct regulatory policy engagement through providing public comments and other testimony as well as meeting with legislators across both sides of the aisle and agency officials. Building on already established relationships with key stakeholders including physician and patient advocacy organizations as well as policymakers, CRRIT will also provide technical expertise in the evaluation of specific policy proposals and pursue convening opportunities to cooperatively advance proposals that further strengthen the evidence base for medical products.