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 ClinicalTrials.gov 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.
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