Clinical Trial Clarity
Drug makers and regulators are taking steps towards transparency, but is it enough?
Pressure is mounting to expand reporting of clinical trials. The AllTrials initiative (www.alltrials.net) – a coalition of 600-plus publishers, charities and funding bodies – is calling for “all past and present clinical trials to be registered and their full methods and summary results reported.” Recently joined by a group of 85 asset managers and pension funds, the initiative is lobbying drug makers to make more data available. New European legislation will make it mandatory to report new trial data in a public database, following the example of clinicaltrials.gov in the US.
Pharma companies are not the only ones guilty of failing to report data – particularly negative data – from clinical trials. A recent study in PLOS One concluded that the number of null results reported in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased significantly since trials started being registered at clinicaltrials.gov. The authors largely attribute the finding to better reporting (1).
Clinical trials registries are crucial because a significant bias against publication of negative trial results remains in STM journals, with up to half of all clinical trials never published (2). However, AllTrials argue that registries are only useful when their use is enforced, citing a 2012 report revealing that only 22 percent of trials subject to mandatory reporting had submitted the results within 12 months of completion (3). While the FDA has the power to fine organizations for failing to submit data, AllTrials claim they have never done so. They also want to see data from past trials made freely available.
To their credit, pharma companies are themselves getting on board with data transparency. Indeed, with drug makers now publically disclosing details of their research pipeline to reassure investors, it would be hard to conceal failures. GSK spearheaded the development of a website allowing researchers to request detailed study results from 12 drug companies.
It seems that we are heading for a new era of openness in clinical trial reporting, and that can only be good news for science, for patients, and for the hundreds of thousands of people who take part in clinical trials, who especially have the right to know the outcome.
Charlotte Barker
Editor
- R. M. Kaplan and V. L. Irvin, “Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time,” PLoS ONE 10(8), e0132382 (2015).
- C. Riveros et al., “Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals,” PLoS Med 10(12), e1001566 (2013).
- A. P. Prayle, M. N. Hurley and A. R. Smyth, “Compliance With Mandatory Reporting of Clinical Trial Results on Clinicaltrials.Gov: Cross Sectional Study,” BMJ 344, d7373 (2012).
As an Editor at Texere, I’m working closely with our audience to create vibrant, engaging content that reflects the hard work and passion that goes into bringing new medicines to market. I got my start in biomedical publishing as a commissioning editor for healthcare journals and have spent my career covering everything from early-stage research to clinical medicine, so I know my way around. And I can’t think of a more interesting, challenging or important area to be working in.
