Yale COMET Project

The Yale Collaboration to Optimize Medical Evidence and Transparency (COMET) Project was formed to serve as a trusted intermediary and provide transparent recommendations on clinical research design and medical product evidence generation. As an effort by academically-based clinical researchers, the Yale COMET Project operates independently of regulators, manufacturers and payers to serve the best interests of patients and the public, while respecting concerns of other stakeholders. An independent organization creates a separation from stakeholders that builds trust in the process, strengthens its integrity, and reduces opportunities for real or perceived influence. We provide fair and impartial assessments of what is needed to advance medical therapeutic and technology evaluation.

The purpose of this work is to directly inform manufacturer efforts to evaluate the efficacy and safety of medical products, including drugs, biologics, medical devices and diagnostic tests, through clinical research studies and to facilitate access to the results and data from these studies.

The COMET Project is guided by the following core principles, which reflect the overall mission to advance evidence generation and promote transparency by:

• Prioritizing research that provides robust evidence to inform clinical decision-making
• Maximizing research resource investment while minimizing risk to patients
• Promoting the responsible conduct of research by ensuring transparency, comprehensive results reporting, and dissemination
• Supporting research data sharing to advance science and improve public health and healthcare while ensuring good stewardship of the data