Johnson & Johnson have recently signed an agreement with Yale University giving the university access to company's clinical trial data as well as the liberty to choose the researchers who will have access to this information.
This move is considered as one of the bravest effort by a pharmaceutical company and it was done to restore trust in the data showed by clinical trials. Over the years, pharmaceutical companies have been involved in controversies regarding their published trials which were suspected to exaggerate the benefits of the drugs and downplay the risks and negative effects associated to it.
"The medical scientific community and population at large want to have more transparency on what we do," said J&J's chief scientific officer Paul Stoffels to the Wall Street Journal. "To get really credible, we took the leap" to come up with an "independent way to make sure people get access to the data."
Under this new agreement, Yale will have the power to solicit proposals from researchers who want to participate in clinical drug trials. Without intervention from J&J, the university will also be able to choose which of these researchers will be given access to the data from clinical trials.
The data which will be given to the chosen researchers will include clinical trials for pharmaceutical products which are made available in the U.S and Europe. The chosen researchers won't be able to identify the patients as all data that may lead to identification of the research participants will be excluded. J&J is also taking several steps to make the data for trials of over the counter drugs and medical devices available to researchers as well.
Cardiologist and head of the Yale Open Data Access (YODA) Project, Harlan Krumholz said to WSJ, "They are sharing their entire trove of clinical trial data assets and they have given us complete authority and jurisdiction over all decisions regarding data access."
J&J's initiative for allowing greater access for clinical trials started when their chief medical officer, Joanne Waldstreicher, heard Dr. Krumholz's lecture about the importance of open access to clinical trial data.
