Historically, our industry has struggled to embrace the idea of transparency, citing the need to remain competitive. Increasingly, however, we see that physicians, patients, policy makers, and the general public expect our industry to lift its veil — especially on clinical research. And, in our opinion, being transparent is not a path to failure — it is a source of strength.
Letting the light in
We took on the challenge to be more transparent over a decade ago and have led the industry since. In 2004, we were the first pharmaceutical company to develop a study registry to post study information and we have progressively added study documents over the course of a decade. In 2013, we were the first to publically post our Clinical Study Reports (these documents are part of regulatory submissions) for studies going back to the formation of GSK in 2000.
Further, we developed a data-sharing platform which has expanded to include 12 other sponsors from our industry. This platform enables us to provide access to the underlying patient level data from our trials so researchers can conduct further analysis, either to validate the results or test new theories. To protect privacy of research participants we provide access to anonymized data after an independent panel approves the research proposal and a data use agreement is signed.
To date, we have posted nearly 2000 clinical study reports and more than 6000 scientific results summaries. Regarding our data sharing platform, we have data from more than 2000 trials available on www.clinicalstudydatarequest.com and dozens of research teams are already using our data to further science and ultimately improve patient care.
Putting it plainly
We always ask what else we can do, what more we can share, and then move quickly to figure out how best to do it. In 2016, we began to develop plain language summaries for our clinical trials to help make the results understandable to a general audience. We will use these summaries to help communicate the results of our clinical research to those who participated. Clinical study participants are the reason we are able to bring novel medicines to market so it is important for us to ensure they understand the results of their participation.
Jessica leads GSK’s global team that develops plain language summaries for our studies.
“As a practicing physician for over a decade and a lawyer committed to improving health policy, I understand patients want to see the results of studies they contributed to, sometimes to see if a medicine might benefit them, but often times because they want to help the next patient. Developing plain language summaries is a way to show our appreciation to patients who made important contributions to our studies and helps take GSK another step forward in our transparency journey.”
This article is part of a series on our responsible business in the US.