Integrity and transparency are paramount to the accuracy, accessibility and credibility of medical research. Given that clinical evidence informs market approval of medical products, missing or inaccurate clinical trial data can directly impact on public health. The Collaboration for Research Integrity and Transparency (CRIT) — an inter-disciplinary initiative launched at Yale in 2016 — acts to promote quality and transparency in medical research. Last week, the group released a new white paper entitled Promoting Transparency in Clinical Research: Why and How.
The white paper outlines three key steps to achieve transparency in clinical research.
- Registration of clinical trials in a publicly available database, such as ClinicalTrials.gov, and prospective sharing of study protocols — ensures studies have clear intentions and design.
- Public reporting of results, including clinical study reports — prevents unnecessary duplication and maximises researchers’ ability to learn from one another.
- Sharing of underlying, analysable data (eg individual patient data) — exposes study findings to scrutiny from independent researchers and also enables inclusion in systematic reviews and meta-analyses.
The free exchange of reliable data between researchers is essential for the continuous progress of clinical research. Yale suggests that this white paper offers a “roadmap” for researchers, regulators, policy makers, and clinicians, to facilitate improvements in the prospective registration of clinical trials, results reporting, and data sharing.