In a major but expected change, pharmaceutical manufacturing giant Pfizer has announced that it will expand the ability of outside researchers and patients enrolled in its clinical trials to access results and other clinical data.
Transparency advocates have for years been pushing for greater access to the data, saying outside researchers should be permitted to validate study results and dig into data to find unreported safety or efficacy issues. And for years, industry has resisted, arguing that public reporting raised the risks of public panic over inconsequential adverse event reports and that competitors could mine the data to support new patents.
But in July, pharmaceutical trade groups PhRMA and EFPIA, together representing the majority of pharmaceutical companies in the US and EU, announced the launch of a new clinical data transparency framework meant to allow companies to establish their own respective policies.
The framework, entitled "Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers," permits "qualified" researchers to access patient and study-level clinical data so long as they are conducting "legitimate" research.
[Read Focus' analysis of the PhRMA/EFPIA framework here.]
Pfizer's New Policy
At the time, the groups said each company would be responsible for formulating and publishing its own policy, which Pfizer has now done.
In a 4 December 2013 announcement, the company said that it will take two approaches toward data transparency: One aimed at providing access for outside researchers, and the other aimed at giving patients participating in its clinical trials access to their personal data.
With respect to outside research, the company will set up a public web portal to offer "qualified" researchers a process to request anonymized patient-level data that have been completed for at least two years. Trials for both approved and discontinued products will be made available, Pfizer said.
Those requests will in turn be vetted by an "external independent review panel" charged with approving or denying requests.
"All research proposals will be assessed to ensure there is scientific rationale for the research, a well-documented and rigorous statistical analysis plan, and a commitment to publish any resulting findings," Pfizer wrote. "Any proposals not fully approved by Pfizer will go to an Independent Review Panel for review and final decision."
Some data will also be provided to the public without requiring them to go through the review panel, Pfizer said.
"Pfizer will publish, on Pfizer.com, synopses of clinical study reports (CSRs) filed with regulatory agencies for approved products for which basic results are posted in the clinicaltrials.gov registry (dating back to September 2007)," the company wrote in a statement. "These CSR synopses will include summary results for all primary and secondary endpoints; any data that could be used to identify individual patients will be removed."
Pfizer said it was also recommitting to publishing the results of all interventional trials, regardless of their outcome, within 18 months of study completion.
Access to Patients
Patients enrolled in its clinical trials will also benefit under the new policy, the company said. Pfizer plans to produce "lay-language" summaries of clinical trial results for any patient who wants to receive it so long as the regulations of the country permit its release.
More importantly, patients will be able to download their own data through the use of a "Blue Button" developed by the US Department of Veterans Affairs and the US Department of Health and Human Services.
It remains to be seen whether Pfizer's model of transparency will in turn influence the models used by other PhRMA and EFPIA members, or if other companies-not all of which are as large as Pfizer-will adopt a phased-in approach. Pfizer's policy is effective as of 1 January 2014, it said.
Other companies are expected to announce their own policies soon, as PhRMA and EFPIA's policy framework is intended to go into effect on 1 January 2014.