A patient view of clinical trial transparency

A Patient View of Data Transparency in Clinical Trials

Medical research could not advance without the many people who volunteer and participate in clinical trials. Regardless of their reason for participating, the majority want to know what information we learned from their trial. It seems a common courtesy to provide that information.

And we have been providing that trial data but not in language easily understood by most patients. I’m proud to say that is beginning to change and I hope readers will take a look: https://www.gsk-clinicalstudyregister.com/search/pls.

In the past, we have shared trial data that could be as complex as something we would submit to the US Food and Drug Administration. There are endpoints, ratios and numbers enough to confuse anyone but an informed scientist or physician.

But GSK has been striving to lead the way in data transparency. That means being transparent in a way that can be understood by our most important group of stakeholders: patients. We are moving to the next step in data transparency by providing plain language summaries of our clinical studies.

This is in addition to the technical summary results of our clinical studies also posted on our webpage (https://www.gsk-clinicalstudyregister.com/) and in addition to the patient-level data available to investigators or interested physicians through the data request site (https://clinicalstudydatarequest.com/).  The plain language summary closes the gap for the patients and the general public.

By sharing the plain language summaries, we hope to encourage better sharing of results with study participants. GSK has posted an initial set of plain language summaries already this year and we are progressively scaling up, gaining experience and feedback as we increase the number of summaries that we post.

These are not translations but are simplified information written at a 12-14 year-old reading level. We seek to have a plain language summary sit beside each scientific summary on our study register but the plain language summary also will include links to scientific summaries for readers who want more detailed information.

We will encourage investigators to share the plain language summaries with trial participants. Feedback is welcome and already has helped us shape the summaries to be more patient friendly. Regulators have advised on appropriate content to include in these high-level summaries.  

We encourage readers to consult their physician before making any changes in their own treatment but hopefully, this next step in transparency will be more helpful to patients and will facilitate deeper discussions by patients with their doctors.