Collaboration for Research Integrity and Transparency
Instead of limiting @CMSgov's authority to an added safeguard for patients, Congress could instead ensure that the agency has sufficient resources to require RCTs for CED to make known the true benefits & harms of new treatments.
Link to piece: https://t.co/9MQuoHCVqH 9/9
Indeed, while RCTs for CED require time & resources, in cases for which it is unknown whether clinical benefits outweigh the harms of medical products at @US_FDA approval, these more robust studies may be necessary to prevent against @CMSgov wasteful & inefficient spending. 8/
Troublingly, Congress has taken steps to limit @CMSgov's authority by requiring Medicare to automatically cover medical products despite uncertainty at @US_FDA approval such as the MCIT pathway w/in Cures 2.0 for Breakthrough Devices & the #DISARMAct: https://t.co/NY5Z6gcQKo 7/
3⃣ @CMSGov could also encourage private payers who face similar uncertainties around benefits & harms of medical products at the time of @US_FDA approval to also require participation in a robust trial as a condition of coverage https://t.co/2HTqfYkDU7 6/
Collaboration for Research Integrity and Transparency (CRIT)
CRIT Program Mission Statement
To promote health by improving the integrity and transparency of biomedical and clinical research
The Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative with a goal to enhance the quality and transparency of the research base for medical products. While no longer actively grant funded, CRIT continues to pursue selective research, advocacy, and litigation to ensure that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable. The lack of transparency and integrity in clinical research has had serious consequences for patient and clinicians. Current legal structures and research practices are not adequate and efforts to understand and improve clinical research transparency and reporting are needed.
By influencing stakeholders engaged in the clinical research process and 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, open science, and informing public discourse.
CRIT aimed to
Achieve a legal and regulatory environment that promotes rigorous clinical research and supports regulatory and clinical decisions that are 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 by facilitating public access to and independent analysis of clinical trial data and results.
Conduct legal, public health and health policy research that identifies strengths and weakness of our existing system for facilitating evidence generation and transparency, and developing and evaluating alternative approaches
Provide the public and key policymakers with tools that enhance and facilitate open access to data, research results, and other relevant information about medical products.