Print“Increasing use of new analytical tools 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.”
Five drugmakers have launched a new online database to provide independent researchers access to anonymized, patient-level clinical trial data under a voluntary data-sharing plan drafted by leading pharmaceutical industry trade groups in the United States and Europe.
The new site, ClinicalStudyDataRequest.com, provides access to data from trials conducted by Boehringer Ingelheim, GlaxoSmithKline, Roche, Sanofi, and ViiV Healthcare. Its creation comes in large part due to pressure from the ongoing AllTrials campaign, an advocacy effort by medical journals, research institutions, patient groups, and some in industry seeking the registration of all clinical trials and the availability of all data recorded in those trials.
Most medicines used today have been tested in clinical trials over the last few decades, but around half the trials of those medicines have not reported results on what was found in the trials, according to AllTrials.
Industry officials say the new site will provide new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and incentives for companies to make long-term investments in biomedical research.
Researchers can submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines created by the five participating companies and approved in the United States and European Union. An independent panel decides whether research proposals to access data should be granted.
Despite the new disclosure, exceptions to what study sponsors are willing to share remain. Most sponsors are excepting clinical studies of rare diseases or single center studies from their data, saying that shielding the identities of patients involved in those studies is too difficult. Others, such as Boehringer Ingelheim, are excluding data and reports for pharmaceutical formulation studies and associated analytical methods, and studies “pertinent to pharmacokinetics using human biomaterials, since we believe that the reports and data for such studies primarily contain commercially confidential information and intellectual property.”
In addition to research proposals to request data from clinical trials already listed on the site, researchers can also submit inquiries to some study sponsors to ask about the availability of data from studies not yet listed.
One participant in the new data-sharing site, Sanofi, says it will continue to submit for publication the results from all company-sponsored clinical studies, regardless of the study outcome. In addition, the company noted in a statement about the plan, the industry is working with regulators to adopt mechanisms so that clinical study sponsors will be able to provide “lay language” summary results directly to people who participate in their trials.
Pfizer has also pledged greater transparency. In December 2013, the company expanded its clinical trial data access policy to simplify and broaden access to information gathered in Pfizer-sponsored trials.
"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,” said Freda Lewis-Hall, Pfizer’s executive vice president and CMO. “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."
January 03, 2014
http://www.burrillreport.com/article-drugmakers_launch_data_sharing_site.html
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