voluntary reporting

A Look at Voluntary Reporting Practices

It’s standard practice for governments around the world to impose reporting requirements on clinical trials conducted in their countries. And while the regulatory apparatus of one country may differ from that of another, there is a common thread throughout the West: the occasional failure of clinical trials to report their results is well-publicized. While media coverage of the issue often gives voice to both sides of the argument–that of the government and the drug developers–it often creates the sense that government requirements are the only reason clinical trial data is shared at all.

This portrayal is not entirely fair. The research industry is well-aware that one of the functions of clinical trial data is to contribute to a knowledge base for future research, and industry innovators have created numerous platforms, independent of ClinicalTrials.gov or any other government database, for voluntary reporting of clinical trial results.

A few of many reporting platforms

One such platform is Clinical Study Data Request, an online resource on which, as of late last year, a dozen pharma companies and research organizations had posted data related to over two thousand clinical trials1. CSDF is built to address two fundamental concerns at opposite ends of the reporting debate: that reporting clinical trial data can compromise patient privacy, and that not doing so can stifle medical progress by making it difficult for researchers to build on previous findings. First, the platform protects patient privacy by posting data anonymously. And as for the second concern, those who wish to access trial data must first submit a request justifying their research-related purpose in seeking that data2. This latter point both ensures those with a legitimate research interest can access valuable information, and quells concerns that offering trial results to anyone who asks can compromise competitive advantage.

Other platforms for voluntary data sharing are disease-specific. Project Data Sphere hosts the results of only cancer-related clinical trials, and is limited to Phase III. It’s also smaller than CSDF, with data from only 55 clinical trials hosted as of this writing. Its services, however, are broad: anyone, from life science companies to hospitals, pharma companies to academic institutions, is eligible for access to the platform3. There is also the recent announcement of a platform for sharing data related to tuberculosis clinical trials. As a number of developing countries are still significantly afflicted by TB4, platforms such as this could be an important boon to medical research in these regions.

Platforms for sharing clinical data on a voluntary basis are valuable resources to medical science. But while the ones listed above may be a good start, there is doubt as to whether they go far enough, or are developed enough to meet the data sharing needs of the clinical research industry. An article published in BioMed Central argues that the process for gaining access to data through some of the platforms that currently exist is too time-consuming, and that the platforms must become more user-friendly if they are to be viable1. Perhaps time will tell: just as these platforms aim to further empower researchers to build upon the findings of earlier trials, we can hope that they themselves serve as the basis for the development of more comprehensive and user-friendly databases down the road.

1 Geifman, Nophar; Bollyky, Jennifer; Bhattacharya, Sanchita; Butte, Atul J.; Opening clinical trial data: are the voluntary data-sharing portals enough?; BioMed Central; 30 September 2015
2 https://clinicalstudydatarequest.com/Default.aspx
3 https://www.projectdatasphere.org/projectdatasphere/html/home
4 http://www.who.int/mediacentre/factsheets/fs104/en/

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