Johnson & Johnson recently struck a deal with Yale to allow the esteemed institution access to the company’s clinical trial data. With Yale University Open Data Access (YODA) Project forming an agreement with the renowned pharmaceutical and medical device manufacturer, it is hoped the move will encourage a more transparent, “open science” approach.
Pharmaceutical companies are renowned for their secrecy, shrouding the results collected from negative trials and clinical data on medical devices and drugs – something the industry has been heavily criticized for. The partnership will introduce an “independent process” that will ensure promotion of data sharing and allow researchers to exploit previous research investments, in a bid to, hopefully, yield new information. The clinical trial data will be released in separate stages, beginning with the unveiling of pharmaceutical trial data; this includes previously unpublished studies. Subsequently, trial data for medical appliances and retail products will also become available to enquiring physicians.
According to Forbes, Joanne Waldstreicher – the chief medical officer at Johnson and Johnson – emphasized the company’s principal ambitions in granting Yale access to its clinical trial data assets. Waldstreicher explains that the company wanted to further medical science by adopting a “broad approach.” Meanwhile, during a prepared press statement, Johnson & Johnson’s chief scientific officer, Paul Stoffels, described their ultimate goal in developing a more open access ethos:
“Responsible sharing of clinical trial data advances science and medicine and is part of Johnson & Johnson’s commitment to the doctors, nurses, patients, mothers, and fathers and all others who use our products.”
Essentially, Johnson & Johnson is set to allow The Yale School of Medicine’s Open Data Access Project the ability to independently review requests from medical physicians and researchers, who submit requests for acquisition of research data on the company’s products; Johnson and Johnson will aid in developing the protocols for assessing these scientific reviews. Once YODA approves a request, the information will be presented to the requesting physician, in a raw, anonymized format. The overall results and conclusions drawn from the study will be passed on, along with the data for each study participant. This radical new approach should ensure researchers are given the opportunity to re-assess and re-assimilate study data sets and combine the information, for utility in other research endeavors.
Once the company has Introduced a fair and balanced means of assessing data requests, the company will allow researchers to submit applications, free of charge. In turn, it is suggested that YODA will reduce barriers to data access, helping to improve research into the positive and negative health impact of specific medical products and drugs. This will ensure both physicians and patients can make informed healthcare decisions, using the latest, most comprehensive evidence at their disposal.
Harlan Krumholz, who heads the Yale University Open Data Access project, recently explained how the move would “usher in a new era of science.” Krumholz explains that he had previously approached other pharmaceutical companies, who were less enthusiastic about the “open science” proposal. However, in light of Johnson & Johnson’s embrace of the new scheme, he hopes that other pharmaceutical companies will take note and follow suit.
By James Fenner