In Nov 2014, the National Institutes of Health (NIH) published a notice of proposed rulemaking that would expand the clinicaltrials.gov registration and results reporting for clinical trials, requiring posting of results for clinical trials of unapproved and uncleared products. This action follows the October 2014 release of the European Medicines Agency’s (EMA’s) policy on the publication of clinical trial data.
There are now in excess of 180,000 trials registered on ClinicalTrials.gov. While reporting of results has improved, less than 16,000 registered trials posted results in 2014.
It has been argued that lack of access to clinical data has harmed patients, led to additional cost, and has inhibited progress in many therapeutic areas. Reproducibility in research is key. The availability of (extra) clinical trial data via the recently announced transparency measures will undoubtedly aid this endeavour.
The benefits of data sharing include cost savings, by eliminating duplicative efforts, and perhaps stimulating further ideas for research. Secondary analyses have sometimes changed clinical practices or shown that interventions are ineffective or unsafe. Most important is patient safety—if you can access data from prior trials on similar study drugs or interventions, researchers may redesign their trial in a way that avoids unnecessary burdens on participants.
Data transparency also offers the opportunity to increase both researcher and public trust in clinical research and the Biopharmaceutical Industry.
It will come at a cost though and a balance will need to be struck to ensure the ongoing economic sustainability of pharmaceutical R&D that is becoming more hobbled in administrative burden. It will also raise new issues and questions, particularly in relation to how research findings and outputs from this increased access should be managed and published.
In addition, some industry leaders have legitimate concerns about issues of patient privacy, potential misuse of data and loss of proprietary advantage.
At the end of the day, what matters most is the correct and optimum treatment of patients. Increased clinical trial transparency moves us closer to this aim and will lessen the fog in what has become a rather murky Looking Glass.
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This article was written by Ric DeGaris from our Clinical Development team.