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Clinical data Transparency

As the date for legislation approaches, each week brings more debate regarding the issue of clinical data transparency
As the date for legislation approaches, each week brings more debate regarding the issue of clinical data transparency. Amidst extensive criticism the pharmaceutical industry has called for more carrot as an incentive for companies to begin releasing their data; and in the face of two lawsuits even the European Medicines Agency (EMA) has had to defend its position on data transparency.

Within the industry there appears to an appetite for increased transparency, with recognition of the scientific and patient benefits. But despite simplistic reporting, the issue of increasing the transparency of data from clinical trials contains complexities not often addressed. Few critics would dispute the benefit of data availability for healthcare professionals and researchers but the issue of wider access does require some thought. The danger of increased access for patients and the general public is the potential harm that may be caused by self-diagnosis. Already the surge of web based health information and the drive for more educated patients means that many are now comfortable with reading up about their conditions and managing their medicines. But there are also clear and known risks associated with self-diagnosis. 

While both healthcare professionals and patients need to be able to make informed and educated choices about treatment it would be of great concern if a time-poor GP had to spend the first five minutes of a ten minute consultation calming down a patient who may have misinterpreted complex data and assumed an unfounded fear about their current treatment.
A second worry is the potential for patients to be identified through personal information. Although providers will endeavour to provide information that has been anonymised, it’s important to remember that in the case of rare diseases there may only be 100 people or fewer in the country with a particular disease. We must ensure that potential trials subjects are not discouraged from future participation because they are worried about their private information being accessible, so data must be methodically and logically analysed with all identifying elelments removed as appropriate.

Transparency of clinical trials data and other research is an important issue and it is therefore critical that all stakeholders, including campaigners and pharmaceutical companies, work closely together. To ensure timely and complete transparency, pharma companies should not be pilloried into releasing data too quickly and at the same time they themselves should put aside rivalry and competitive issues to work together for the ultimate good of the patient. All involved need to look at the scientific, academic, patient and societal benefits and realise that done well, increased access to clinical data could benefit all, but if mistakes are made the consequences could be far reaching.       

8th November 2013

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