Pfizer’s initiative to return clinical trial data to patients recognizes participant contributions and sets the pace for the industry

By Bruce Hellman

Chief Patient Officer and Co-founder of uMotif

Well done Pfizer!  I was delighted to read the recent news from Pfizer announcing the launch of their Participant Data Return, which will return individual data to patients at scale. This approach is welcome. It will mean that patients from the US will receive a summary of their data, in a visual, easily understood format, approximately 12 months after study completion.

Providing participants’ data back to them is one way of thanking, recognizing, and appreciating the effort, time, and sacrifice that patients extend when taking part in studies. It is essential that patients are viewed and treated as active participants, moving away from out-dated terminology and viewpoints, which made people mere “subjects.” This ethos is key for the future of truly patient-centric research – something our CEO Steve Rosenberg has talked about in this recent article.

But, can we take the data-return approach further to provide even greater benefits to participants – an idea that becomes even more profound when one considers the rapid growth in real-world studies?  How about sharing data in real-time to support a participant’s personal healthcare journey during the study, not just afterwards?

In some clinical trials, the answer will clearly be “no” to real-time data sharing, as this could introduce bias or affect the scientific validity of the trial. However, in some trials or real-world studies, it’s likely that providing some types of data to patients during the trial could both benefit the person, while also maintaining study rigor.

For example, during the University of Manchester-sponsored Cloudy With a Chance of Pain study, we used the uMotif platform to present participants their data in real-time. In this real-world study involving over 12,500 participants, researchers explored the relationship between pain and the weather. Participants used their own devices to capture daily patient-reported outcomes (PROs) including pain and other symptoms, as well as the local weather sourced from the UK Met Office. In addition, participants who had wearable devices could also track daily step counts and other objective data.

To maintain scientific rigor, the research team was happy for participants to view graphs of their pain levels, step counts, and the local weather pressure. However, to ensure participants were not biased, the data related to local temperature and precipitation were not available to view.  Participants commented that the ability to review real-time data helped maintain engagement  – leading to over 5 million data points being captured.

This experience has informed our philosophy of aiming to share data with patients if and when it does not affect the scientific rigor of the study. Aligned with Pfizer’s summary data reports, each Cloudy with a Chance of Pain study participant was able to receive an intuitively designed postcard summary of their data. By thoughtfully designing a personalized data summary, participants felt appreciated and recognized for their participation.

Many participants also appreciated receiving information about the results of the study, published in Nature. Here’s the link if you want to check out the results. Spoiler alert – there were associations between certain aspects of the weather and people’s self-reported pain.

Again, well done Pfizer. I am hopeful that this development will further catalyze patient-centric approaches to every aspect of a trial, which can spread beyond the US and be embraced by sponsors around the globe.