In an effort to deflect criticism that information gathered in clinical trials is rarely released, GlaxoSmithKline plans to open the door on much of its drug research data. GlaxoSmithKline will open its clinical trial data once a drug has completed the approval process or been abandoned. An independent panel of experts will review requests submitted by researchers and if the requests are deemed to have scientific merit, the company’s data will be made available to the researchers via a secure website. The new policy applies to global clinical trials since 2007 and all clinical trials starting in 2013.
Researchers expressed a mix of enthusiasm and skepticism for the plan. Some of the researchers said that the company is taking a step in the right direction and might set a precedent in an industry that could use more transparency. Dr. Harlan M. Krumholz, a cardiologist at the Yale School of Medicine, said, “This is a reason to celebrate a company stepping forward to make a public commitment to sharing their data at the individual patient level and fostering open science. The hope is that it would make it untenable for other companies not to follow suit.”
After experimenting with disclosure for treatments for tropical diseases like malaria, Glaxo has found those efforts to be successful and is ready to move forward with more disclosures. The company also plans to release information about 200 of its experimental drug compounds that have shown signs of fighting tuberculosis. Joshua M. Sharfstein, Maryland’s health secretary, said, “Making data available, particularly on the products that didn’t succeed, could avoid others having to learn the same lessons.”
Whether more disclosure will lead to more effective, safer drugs remains to be seen. Dr. Patrick Vallance, president of pharmaceuticals research and development at GlaxoSmithKline, said, “We’re increasingly realizing that the more you can make this an open enterprise, the more likely you are to be able to get an advance which allows you to make a medicine. I think we recognize that you learn as much about the medicine after it’s launched as you knew before.”