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In this interview, we speak to Dr. Joanne Waldstreicher, Chief Medical Officer of J&J’s Office of the Chief Medical Officer (OCMO), to discuss its data sharing program via the Yale University Open Data Access (YODA) Project.
Clinical trial data sharing has been growing in the biopharmaceutical industry, as non-profit organizations, such as Project Datasphere and BioCelerate, have initiated data sharing programs. Other enterprises, such as GSK and Johnson & Johnson (J&J), have taken data sharing into their own hands to engage researchers directly. In this interview, we speak to Dr. Joanne Waldstreicher, Chief Medical Officer of J&J’s Office of the Chief Medical Officer (OCMO), to discuss its data sharing program via the Yale University Open Data Access (YODA) Project.
Moe Alsumidaie: Tell me more about your role and the role of the OCMO at J&J.
Joanne Waldstreicher: Since 2013, I have been the Chief Medical Officer of J&J and leading the group that is called the Office of the Chief Medical Officer. Our group is responsible for the assessment of the safety of all our products around the world including pharmaceuticals, medical devices, and consumer products. We are working on clinical trial regulatory operations transformation and we also work on the policies that have an ethical, moral, or R&D component to them. We always keep the best interests of patients and consumers at the center of all our decisions.
MA: Why is data sharing important?
JW: At J&J, we believe that sharing clinical trial data advances the science that is the foundation of medicine and gives the data a second life. The data were developed to answer certain questions, but there are other questions that can be answered by generating more hypotheses. For example, looking at different tools or ways of validating tools within our database.
MA: Why does data sharing matter for patients? Is data sharing limited to researchers, or can patients also access their study data?
JW: Data sharing is important to the patients who volunteer to participate in clinical trials by giving us their time, their efforts, and their bodies to help advance research. We believe that we honor these patients by responsibly sharing their clinical trial data with other researchers around the world in an effort to help science and to help other patients in the future. At J&J, patients can access their data with the investigator once the study is complete. We are working in partnerships with other organizations, like the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, to look at different ways of sharing data summaries or individual patient data.
In our experience, we understand that patients want to be able to access their own data, and we believe it is good for them to be able to own their health records, even when generated in clinical trial settings. Patients are our partners in research, and as partners we should be able to engage them and share the data with them. It also helps them better control their health. We can’t advance science without patient participation. The more engaged they are, the more feedback they will be able to give us, the better it will be for science and for patients.
MA: How did you come up with the idea of the YODA Project?
JW: The YODA Project is run by the Principal Investigator Harlan Krumholz, MD, who has been an advocate for responsible data sharing and was a classmate of mine from medical school. While I had been advocating for responsible data sharing inside of J&J, he had been trying to make data sharing work on a much broader scale from the outside, in academia. Our paths crossed again at an Institute of Medicineconference, and when we met, we realized our shared interest in making a clinical data sharing project possible-with Dr. Krumholz adding the academia perspective, and mine from the industry. We forged a partnership between Janssen Pharmaceuticals and the YODA Project that launched in 2014. In doing so, J&J became the first company to partner with an independent external academic group like Yale. Several other companies now have followed suit. YODA independently evaluates all of the research requests that it gets from external investigators to access our data, and they have final and full decision rights on data requests. Today we share with researchers our clinical trial data from across the J&J enterprise, including pharmaceuticals, medical devices, and consumer products. We are the only large device and consumer company that shares clinical trial data.
MA: How can researchers apply to access the shared data? What is the process?
JW: The YODA Project has a website where researchers can access a list of clinical trials that have data available. In addition, researchers can visit www.clinicaltrials.gov, look up any clinical trials from J&J that they are interested in, and then go on the YODA Project website and request access to a specific dataset. When initiating applications, researchers need to have a scientific hypothesis and submit a data analysis plan. Applicants submit proposals directly to the YODA Project, which is responsible for all communication with applicants. YODA Project scientists conduct a review of proposals to ensure that the scientific purpose is clearly described, that the data requested will be used to create or materially enhance scientific knowledge and public health and that the proposed research can be reasonably addressed using the requested data. The J&J teams review the blinded research proposal in parallel to answer the factual question of whether the data being requested are able to answer the question being asked. They give their feedback to the YODA Project who makes the decision. Then J&J is notified of the decision.
J&J then puts the dataset on a secure analytic environment that the YODA Project will then give the researcher access to. The system for sharing data was designed to ensure cooperation with the data owner in promoting secure, responsible access, but independence with regard to data-sharing decisions. Every once in a while, we may get a request for a clinical trial that is not ours or a request for data from a clinical trial that we participated in but we do not own the data.
MA: What has been the experience with the YODA Project to date-do you consider it a success?
JW: As of May of this year, we have had 73 proposals that request data from more than 150 clinical trials. So far, 63 of those proposals have been approved, six of them have been closed or withdrawn before they were finalized and some are still being reviewed by the YODA Project. Most of the requests are from academic investigators. Some looked at new hypotheses for the data such as gender differences, or sub group analyses, and then several have done comparative analyses. Researchers have requested our data as well as data from other companies and looked across products. They have done either pooled or meta analyses across products to look for comparative effectiveness and safety. We have also received interest from organizations such as the World Health Organization to access data in order to assist with the development of clinical guidelines. The majority of the requests for data have been looking at the development or validation of new tools or looking at verifying new types of measurements. So far, five manuscripts have been submitted for publication and two have been published. We are quite happy with the experience. Data sharing is new, and it is already contributing to scientific literature.