Featuring the lack of transparency across clinical trials in French hospitals, the introduction of Registered Reports, the data detective who protects patients and one patient advocate’s experience with the medical publishing process
Over the past few years, pharma has vastly improved the transparency of its clinical trials. However, can the same be said for all clinical trial sponsors? Recent data compiled by Hospimedia, using the EU Trials Tracker, revealed that only 10% of French university hospital centres have uploaded any results to the European trial registry. The authors of this article, in line with European Union transparency rules, argue that publishing clinical trial findings as a polished overview in academic journals is not an alternative to uploading trial results to online repositories. Journal publications are often behind paywalls, but registry records are freely accessible to all. With industry so frequently under scrutiny to report all clinical trial findings, it is disappointing to see such a low performance in reporting by university hospital centres.
Failure to replicate study results has been well documented across numerous disciplines. This may in part be a result of publication bias, whereby authors and publishers favour positive results over negative results and failed studies. However, not sharing negative study results is detrimental to future research endeavours, wasting both time and money in futile pursuits. As discussed in last week’s Open Pharma digest, the way in which researchers communicate their findings needs to be updated. Registered Reports are research plans or protocols that are submitted by authors to their journal of choice before data collection for their study has begun. The research questions, methodology and analysis plan are subject to peer review and, if the journal is satisfied with the overall report, the study is accepted for publication before obtaining any results. Approximately 200 journals now accept Registered Reports, with the aim to publish good-quality studies irrespective of their results.
The article tells the story of John Carlisle, anaesthetist and cat enthusiast, who investigates suspicious data in clinical trials in his spare time. Although some publishers have questioned John’s methods, his work has led to the correction of hundreds of research papers and, in some cases, retractions. In 2017, John published data claiming that, over a 16-year period, 90 out of more than 5000 published clinical trials contained suspect data. John suggests that journals and institutions, as the gatekeepers of science, could and should be doing more to spot mistakes and fraudulent data.
The story of one patient advocate via The Publication Plan
This week, The Publication Plan interviewed award-winning patient advocate, consultant and researcher Simon Stones about his experience, as a patient, in the medical publishing process. Having started out as a patient representative in a paediatric rheumatology group, Simon shared how his experience of working as an advocate has allowed him to take control of his own health. “If we’re talking about patients, why aren’t they involved?” Like many others, Simon believes that patients should be involved at each stage of the research process and hopes that current models of research design and communication will continue to adapt accordingly.