GlaxoSmithKline Plc (GSK) plans to disclose more individual patient data from its clinical trials to increase transparency in how it reports drug-study results.
Since May, qualified researchers can request access to findings on individual patients whose identities are concealed and confidentiality protected. The drugmaker will double the number of studies to 400 available by year’s end to researchers seeking data of approved medicines and of therapies that have been terminated from development, Perry Nisen, senior vice president of science and innovation at Glaxo, said in a report published yesterday in the New England Journal of Medicine.
The initiative is among the ways the industry is trying to address the fact that thousands of clinical trials that can help improve patient care haven’t been published, according to Ben Goldacre, a doctor and author of “Bad Pharma.” Enabling access to patient information can also help improve research.
“Risks regarding data privacy and irresponsible use cannot be totally eliminated, and it will be a challenge to accommodate diverse expectations across the scientific and medical community,” Nisen said in the report. “However, the opportunity to benefit the health of individuals and the public must outweigh these concerns.”
The GlaxoSmithKline Clinical Study Requests website, introduced May 7, lists studies started from Jan. 1, 2007. Researchers with “scientific credibility” can submit proposals for use of the data, with a panel of external experts providing a decision within 30 days, Nisen said. The London-based drugmaker has said it plans over the next two years to add all global studies back to December 2000.
The European Medicines Agency last month released a draft policy on publication of clinical trial data, a step designed to improve transparency that affects all drugmakers seeking permission to sell their medicines in Europe. The move has sparked debate throughout the pharmaceutical industry.
To address concerns raised, the EMA has separated clinical data into three categories: commercially confidential information; open-access data that doesn’t contain patients’ personal information; and controlled-access data that will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement.
Historically, each proposed increase in trial transparency has elicited concerns, including the possible loss of competitive or commercial advantage and the potentially negative implications of increased public access, including the possibility of invalid secondary analyses, said Deborah Zarin, the director of ClinicalTrials.gov, an international registry and results reporting system for studies.
“We have to learn as much as we can from these experiments about the benefits, risks, costs and appropriate role of disclosing participant-level data,” she said in a comment accompanying the report in the medical journal.
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