Collaboration on Research Integrity and Transparency
The Collaboration for Research Integrity and Transparency (CRIT) was an inter-disciplinary initiative launched in 2016 to enhance the quality and transparency of the research base for medical products. Through research, advocacy, and litigation, CRIT was focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products were accurate, comprehensive, accessible, and reliable. The lack of transparency and integrity in clinical research has had serious consequences for patients and clinicians. For example, there was the case of Vioxx, where risks of serious, life-threatening side effects were hidden by the manufacturer from physicians and the public. And there was the case of depression treatment with drugs known as SSRIs, where clinical trial data was selectively published and results were selectively reported, minimizing the risk of suicide associated with the drugs. Current legal structures and research practices were not adequate and efforts to understand and improve clinical research transparency and reporting were needed.
CRIT aimed to
- Achieve a legal and regulatory environment that promoted rigorous clinical research and supported regulatory and clinical decisions that were grounded in high-quality research and accessible data and results.
- Strengthen the integrity of research of medical products by ensuring that data is both rigorous and reliable, and facilitated public access to and independent analysis of clinical trial data and results.
- Conduct legal, public health and health policy research that identified strengths and weakness of our existing system for facilitating evidence generation and transparency, and developed and evaluated alternative approaches
- Provide the public and key policymakers with tools that enhanced and facilitated open access to data, research results, and other relevant information about medical products.
- influence stakeholders engaged in the clinical research process or in translating these findings for clinical care, CRIT focused and magnified the impact of our and others’ scholarship, policy analysis and legal action, advancing the field of research integrity and informing public discourse.
For further information, please visit CRIT at the Yale Law School.