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Push for greater trial data transparency grows
January 12th, 2015
In light of growing pressure from critics urging companies to make clinical trial data accessible to the public, Pfizer announced plans to open up its data to both researchers and trial participants.
Starting next year, Pfizer will make clinical research data available to trial participants in an understandable, jargon-less format. Participants will also be able to access their personal clinical data from the trial, going beyond just the patient’s response to the study drug. Investigators can submit requests for de-identified trial data as part of what Pfizer considers “high-quality scientific reviews.”
The move comes on the heels of a greater push this year to make clinical trial data more accessible. Starting next year, regulators in Europe will begin publishing data from pharmaceutical companies seeking drug approval. Over the summer, I wrote about a group of researchers urging clinical trial sponsors to publish lost or abandoned trial data in the name of transparency, or make the data available for others to publish. This information should be published, the authors say, “because abandonment can lead to false conclusions about effectiveness and safety, we believe that it should be tackled through independent publication and republication of trials.”
And a recent study published in BMJ found that nearly one-third of registered clinical trials go unpublished five years after completion, despite requirements from the Food and Drug Administration Amendments Act. Trial registration, the authors say, discourages trial sponsors from giving publication preference to statistically significant outcomes, and can increase awareness of publication bias by allowing citizens to compare journal-published results with the reports on ClinicalTrials.gov.
Pfizer isn’t the only pharma company to provide access to trial data. Last year, GlaxoSmithKline announced its own intentions to make clinical trial reports and other data accessible to researchers and investigators.