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Trials. 2016 Feb 11;17:78. doi: 10.1186/s13063-016-1194-7.

Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency.

Author information

1
Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, 220 Arch St, Floor 12, Rm. 01-228, Baltimore, MD, 21201, USA. pdoshi@rx.umaryland.edu.
2
Cochrane Acute Respiratory Infections Group, 00187, Rome, Italy. jefferson.tom@gmail.com.

Abstract

BACKGROUND:

Clinical trial (and other) data from the European Medicines Agency (EMA) offers the best available opportunity to address the extensive reporting bias in pharmaceutical trial literature. Data are requested via freedom of information requests, but 5 years on, little is known about how the system is working.

METHODS:

Case series of 12 requests for regulatory data (clinical study reports and other regulatory data) relating to 29 different compounds. We logged start and end dates for correspondence with and data releases from the EMA, the need for additional correspondence and appeal of initial negative decisions, and inspected data releases for redaction. We measured: time from initial request to first substantive response from the EMA, to final decision from the EMA (in case of appeal), to initial receipt of documents, and to completion of request; number of data transmission batches generated; number of pages received for each request; average number of pages per batch over time (for releases in multiple batches); judgment as to whether the request was satisfied.

RESULTS:

We found great variability in time to receive an initial decision from the EMA (1 to 13 weeks). Additional correspondence with the EMA was necessary in 10 of 12 requests. Four of 12 were initially refused but 3 of 4 were allowed on appeal after 3 to 33 additional weeks. One request was denied despite appeal. Time to final decision was 1 to 43 weeks. We received data for 11 of 12 requests in 98 batches. While two requests remain outstanding as at June 2015 the remaining nine requests took a median 43 weeks to completion (range: 17 to 186 weeks). Despite redaction in 10 of 11 releases (mainly of researcher and participant identifying information), 8 requested were wholly satisfied.

CONCLUSIONS:

The EMA is the only regulator in the world that is routinely releasing original clinical trial data, but release can take considerable time to occur and often only after a lengthy correspondence. Given its importance for research and significance for transparency we suggest ways in which the process could be made more efficient.

PMID:
26865363
PMCID:
PMC4750208
DOI:
10.1186/s13063-016-1194-7
[Indexed for MEDLINE]
Free PMC Article

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