Chasing clinical trial data

doctor silencedA recent issue of BMJ highlighted the problem of missing clinical trial data from medical research, exploring both the causes and consequences of unpublished evidence.  One of the articles, from Andrew Prayle and colleagues [1], examined compliance with the US Food and Drug Administration’s ostensibly mandatory requirement that clinical trials report their results in, as required by the the FDA Amendments Act (FDAAA) of 2007. Alarmingly, they found that only 22% of trials that should have reported results had actually done so.  Interestingly, industry-funded trials reported results at a higher frequency than other funders.  They conclude:

If the reporting rate does not increase, the laudable FDAAA legislation will not achieve its goal of improving the accessibility of trial results.

Fortunately for those interested in this research, the authors have ensured that their own data are available by depositing them in Dryad, where they have already been downloaded by over 100 users.

For more on the disturbing state of affairs in reporting of clinical trial data, we offer the irrepressible Ben Goldacre speaking at the Strata 2012 conference in February.

[1] Prayle AP, Hurley MN, Smyth AR (2012) Compliance with mandatory reporting of clinical trial results on cross sectional study. BMJ 343: d7373. doi:10.1136/bmj.d7373

BMJ Open: a new partner and an expanded scope

Dryad is pleased to welcome BMJ Open as a new partner journal, reflecting the recently expanded scope of repository to be inclusive of all of basic and applied biosciences, including medicine. BMJ Open is a new online-only, open access journal from the esteemed London-based BMJ Group.  It is dedicated to publishing medical research from all disciplines and therapeutic areas, utilizing fully open peer review and immediate online publication.

BMJ Open authors are now being strongly encouraged to deposit the data underlying their articles in Dryad or a more specialized repository, as appropriate.  Authors submitting articles to the journal will benefit from Dryad’s journal submission integration, the process by which data deposit is streamlined for authors through behind-the-scenes communication between the journal and the repository.

An extremely important issue with archiving medical data is, of course, the need to protect patient privacy. To assist its authors, BMJ Open is providing special guidance on data sharing.  Authors must be able to release data to the public domain as with all data in Dryad, and the repository will err on the side of caution by turning back any data that may compromise patient privacy.

To quote from the BMJ Group press release:

Data sharing aims to help scientists and doctors validate and scrutinise researchers’ findings in a bid to prevent fraud and eradicate the kind of selective reporting that has enabled some treatments to acquire regulatory approval, based on incomplete and biased data. In some cases this lack of transparency has prompted the subsequent restriction or withdrawal of certain treatments because of patient safety or effectiveness concerns, which were already evident in the unpublished data.  Data repositories also allow researchers to develop new methods of analysis and use the data to answer questions that the original researchers have not thought of. They also facilitate the acquisition of data for meta analysis (more in-depth comparative reviews).

Commenting on the move, Dr Trish Groves, editor in chief of BMJ Open, said: “Since launch, BMJ Open has championed transparency in medical research through open peer review, open access, and full reporting of studies’ methods and results, all exemplified by last week’s paper on the safety (or not) of medical devices (doi:10.5061/dryad.585t4)…”

This data package in Dryad, which illustrates the tremendous value of medical data for informing medical policy and practice without compromising patient privacy, is available at:

  • Heneghan C, Thompson M, Billingsley M, Cohen D (2011) Data from: Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. Dryad Digital Repository. doi:10.5061/dryad.585t4

Groves goes on to say

We strongly encourage authors to share their datasets, and now we’re delighted to be making that easier to do, with the help of DryadUK.

Kudos to the Dryad UK project team, based at the British Library, for facilitating this pioneering partnership.