Friday, November 3, 2017

CRIT Releases Paper Promoting Transparency in Clinical Research

Yale’s Collaboration for Research Integrity and Transparency (CRIT) released a white paper on November 3, 2017, entitled “Promoting Transparency in Clinical Research: Why and How.” The document details the harms caused by a lack of transparency regarding clinical research about drugs, biologics, and medical devices.  

In a forward-looking analysis, the faculty and staff of CRIT—Yale’s partnership between its law, medical, and public health schools—describe not only the harms caused by lack of transparency, but also the current state of transparency efforts and an agenda for transparency for the future. The white paper specifically explains why prospective registration of clinical trials, public reporting of study results, and data sharing with independent researchers, act as checks and balances.

 “Prospective registration of clinical trials, including a study protocol and statistical analysis plan with research objectives and endpoints clearly specified before the trial begins, provides clear documentation of study intentions and design for the scientific and clinical communities,” said Margaret McCarthy, the Executive Director of CRIT. “Public reporting of results limits the likelihood that unsuccessful research will be unnecessarily duplicated or that our collective understanding of a product’s benefits and safety is not distorted. Data sharing with independent researchers can allow research findings to be checked by researchers without a vested interest in positive results. All three steps provide important checks and balances necessary to ensure that medical products research is conducted and described in a scientifically accurate manner.”

The white paper offers a roadmap for improvements in prospective trial registration and results reporting and data sharing, balancing the competing needs of researchers, regulators, policy makers and clinicians.

CRIT is 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 is 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 is accurate, comprehensive, accessible, and reliable. Read a blog post about the paper here