Clinical trial data transparency is the right thing to do

By Dr. Murray Stewart, Chief Medical Officer, GSK

At times, there can be a huge gulf between principle and practice. For example, eating healthy foods and getting lots of exercise are clearly beneficial, but they require commitment and hard work and are not sustained by many people.

Expanding access to clinical trial information is another principle that attracts widespread support, but in practice, it takes a lot of commitment and hard work by many across the health care network. Despite the challenges, there have been significant strides made by the biopharmaceutical industry in putting this principle into practice.

Researchers can now access detailed trial data from many companies to support their own research and, hopefully, benefit medical science and patients. GSK and 11 other companies provide access to data through a common online website (www.clinicalstudydatarequest.com). Other companies have created their own systems consistent with the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing.

The move from making promises to changing practices is best demonstrated by the metrics: At GSK we offer the very detailed, anonymized patient-level data from more than 1,500 of our trials and that number is growing. More than 100 requests have been made for data since the system’s launch in 2013, and we have already provided over 50 research teams with access to data.

One or two requests have been to re-analyze data from old trials – which we support when carried out with appropriate scientific rigor – but the majority have been from researchers armed with a fresh perspective, using new research methods or trying to identify factors that predict disease progression or outcome. This research is an opportunity to advance medical science and improve patient care.

Like the person who encounters obstacles to following their own diet and exercise plan, we can and should stay the course because it is the right thing to do for patients. Achieving this important goal has required our industry to dedicate resource to find sustainable solutions and address legitimate concerns, like how to protect patient privacy and encourage appropriate scientific use of data.

Opening access to our data has not been a quick or easy journey – and it’s a journey we’ve been on for more than a decade. But, with 50 research teams around the world using GSK’s data, the effort is a success –and there is still more work to be done.

The biopharmaceutical and scientific communities must continue to work together on this journey. There is surprising reluctance among academic groups to share data – perhaps over concerns about the complexity of the process, costs and realities of implementation. But these concerns can be overcome.

At GSK, we would like to see a broad, independent data-sharing portal to provide access to data from across all of industry and academia. This concept is being developed by groups such as the Harvard- Multi-Regional Clinical Trials Center (MRCT), the Wellcome Trust and the Arnold Foundation in partnership with the Institute of Medicine. We’re excited to be involved in these discussions.

Data transparency is not an easy principle to put into practice, but we are seeing positive results.  We still need new treatments for diseases and there are still many scientific unknowns that stand in the way of developing those treatments, though our motivating hope is that by sharing knowledge and data, we can help solve some of the world’s trickiest scientific questions.

Murray joined GSK in 2000 as Associate Director for Clinical Research & Development in the UK and since then has held a variety of positions in GSK mainly in R&D. He was clinical head of the biopharmaceuticals unit and then therapy area head for the Cardiovascular and Metabolic therapy area.

Currently he is Chief Medical Officer for GSK and as such has global responsibility for patient well being across the vaccines, pharmaceutical and consumer business units.   He has had extensive clinical development experience and worldwide regulatory interactions.