In a move toward scientific transparency, Johnson & Johnson will share some of its clinical trial data under an agreement with Yale School of Medicine’s Open Data Access (YODA) Project. This is the first time a company has ceded all decision-making authority over the release of its data to an independent third party. “By establishing this fair and independent process to release data, Johnson & Johnson has taken a leadership position in this emerging era of open science,” said Dr. Harlan Krumholz, director of the YODA Project and professor at Yale School of Medicine.
Janssen Research and Development, the J&J pharmaceutical subsidiary that signed the agreement with YODA, will not only share pharmaceutical data, but also information from medical device and consumer product trials. Researchers will submit proposals to review data from studies of products that are being sold, and YODA will be responsible for reviewing all requests and deciding the terms of access. Any identifying details will be redacted so that individual participants in scientific studies remain anonymous. All data will be free of charge.
“We are pleased to collaborate with YODA to ensure that each and every request for access to our pharmaceutical clinical data is reviewed objectively and independently,” said Dr. Joanne Waldstreicher, chief medical officer at Johnson & Johnson. “This represents a new standard for responsible, independent clinical data sharing.” Janssen has launched a web-based tool to assist researchers in their requests for access. Submitted proposals will be posted publicly and registered at clinicaltrials.gov.
Although J&J has chosen YODA to mediate its new transparency, this is not a first in terms of data sharing within the pharmaceutical sector. This past December, Pfizer updated its clinical trial data access policy and as of the first of this year began the process of sharing with researchers anonymized patient-level data from trials of already approved products. The company will also share data and results with study participants in trials going forward. The actions of both Pfizer and J&J reflect an industry-wide trend toward open science.
Though the risks may be considerable — a breach of intellectual property here, mistaken analysis that leads to unwarranted litigation there — it is difficult to believe there will be no rewards for these goliaths of industry. Under its new policy, Pfizer requires those who want access to sign a data-sharing agreement. Any science conducted by others, then, will likely benefit the company. Ultimately, how this new trend plays out is anyone’s guess, but considering both big business and big academia have put their heads together on it, the gains should be profound. Of course, one can hope the patients benefit above all others.