In 2017, I was drafting the first manuscript for a phase I clinical trial. I was familiar with the consolidated standards of reporting trials (Consort) for randomised parallel group trials, so I was surprised by the absence of Consort reporting guidance tailored for early phase dose finding trials.
After searching top medical journals for published dose finding trials to assess how they had been reported, I found huge variation in what was being reported and their quality. This presented some big problems for medical research poor reporting in clinical trials jeopardises patient safety, erodes public trust, wastes vital resources, and hinders medical progress. Despite the pivotal role of these trials in shaping future clinical development, the importance of quality reporting had arguably been overlooked. It’s undeniable: we need robust reporting guidelines to enhance transparency and ensure reproducibility.
Serendipitously, …