Under its transparency plan, next year Pfizer will open up its books to "qualified researchers," handing over anonymized, patient-level data from both successes and failures that have been wrapped up for 24 months. Just what qualifies a researcher remains a little unclear, however, and Pfizer said only that it will look for "scientific rationale for the research, a well-documented and rigorous statistical analysis plan and a commitment to publish any resulting findings."
But it's not all so subjective. If Pfizer rejects or only partially approves a request for data, researchers can go to an external independent review panel which will have final say, according to the company.
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| Pfizer's Freda Lewis-Hall |
In its announcement, Pfizer takes pains to highlight its respect for patient privacy but doesn't rule out lending its years of data to would-be competitors, provided the recipients are willing to share alike, as Executive Vice President Freda Lewis-Hall said.
"Increasing use of new analytical tools and processes to better understand patient outcomes suggests that broadening access to information from clinical trials, including patient-level data, when done responsibly, may benefit medical research and public health," Lewis-Hall said in a statement. "Pfizer's expanded policy is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient privacy, respect the regulatory process and maintain incentives to conduct new research."
Last year, GlaxoSmithKline ($GSK) enacted a similar effort, emptying its tuberculosis research coffers for any and all but, for patient-level data on other disease, employing an independent panel of experts to "ensure that this information will be used for (a) valid scientific endeavor."
- read Pfizer's statement