Commentary: RECORD response

Studies such as RECORD1 highlight the difficulties of assessing the safety profile of medicines for the treatment of long term conditions. Our response should be measured and recognise the complex issues involved in the design, conduct, and evaluation of studies that explore risks and benefits of treatments. It is too simplistic to assert that collusion between sponsors, investigators, authors, and data and safety monitoring boards is the root cause.

With regards to Steinbrook and Kassirer’s (doi:10.1136/bmj.c5391) first criterion, it is hard to imagine any institution—whether academic, industry, or governmental—allowing unfettered analyses of their research data. Many institutions support data release for exploratory research and meta-analyses, protected by formal agreements for …