Friday, March 22, 2013

Open Access to Clinical Trials Data?

In a potentially revolutionary development the European Medicines Agency (EMA) plans to begin broad public access to clinical trials data, including company reports. The exact format remains under discussion, but clearly this new approach will be radically different from former practices at the EMA and current practice at the FDA wherein commercially generated data is available only to the regulators but not the public.

There are clearly many positive aspects of the EMA’s plan. Thus it will allow unbiased academic investigators and other knowledgeable individuals to evaluate the entire clinical data set and not just limited material selected for publication or for posting on the US site. It also seems likely that early availability of clinical data will reduce the number (and immense cost) of essentially redundant trials of similar drugs done by different companies.

Some in the pharmaceutical industry have expressed strong concerns about the EMA plan. One potential problem involves intellectual property; open access to clinical data may prematurely reveal key IP and provide advantages to competitors. Another issue is that full access by the general public may result in health scares as data is misinterpreted by laymen. Perhaps the greatest concern regards patient privacy. Although the data would be anonymized, it is possible that security could be penetrated.

Likely the optimum resolution of these issues will involve some sort of ‘gatekeeper’ that will allow parties with legitimate interests to view the full data while screening out more frivolous requests. However, setting up a fair gatekeeping process will no doubt be challenging.

Despite some problematic issues, the EMA thrust is clearly a step forward in providing greater openness, rationality and productivity in the drug development process. 

No comments:

Post a Comment