On Pfizer’s initiative to return clinical trial data to patients

The average dropout rate in clinical trials hovers at about 30%. Among the most common reasons for dropping out, patients cite a lack of communication about the trial, and feeling their sacrifices of the time and energy required to participate – especially when they face serious health issues – are not appreciated. Keeping patients informed and educated can go a long way towards improving retention rates and keeping studies on track.

Which is why I say 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 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, recognising, and appreciating the effort, time, and sacrifice patients extend when they take part in studies. It is essential that patients are viewed and treated as active participants, moving away from outdated terminology and viewpoints, which made people mere “subjects”. This ethos is key for the future of truly patient-centric research, and something many in the industry have been talking about for years.

But can we take the data-return approach further? To provide even greater benefits to participants? This is 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?

Real-time data: On pain and weather patterns

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, participants were able to see 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 a 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 personalised data summary, participants felt appreciated and recognised for their participation.

A community ethos for patient centricity

Sensitively sharing data during the trial can be of huge benefit in engaging and retaining participants, and making patients feel part of the wider research community. The sense of community presents another exciting way to make trials more patient-centric – by inviting participants to become part of something bigger, beyond the trial.

One example of such a community is the patient-led “Our Brain Bank” initiative, founded by the late Jessica Morris, to turn glioblastoma from terminal to treatable. From Jessica’s inception, Our Brain Bank combined a patient-led research study with a wider community for those suffering this rare and aggressive form of cancer.

Sharing data and feeling part of a community can help engage and retain participation during the trial. But what about the results of the trial, which many patients never receive? As with the Pfizer approach, participants in the Cloudy study appreciated receiving information about the results of the study. By feeding back to participants on the eventual outcome, sponsors can close the loop of participation and put their valuable contribution into context. Patients often comment that they want to know what happened – whether the trial was positive or negative. It’s an opportunity to say ‘thank you’, and to encourage participation in future research – making today’s participants the recruits of tomorrow’s trials.

The results of Cloudy were published in Nature journal in October 2019, which for the first time demonstrated at scale 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 catalyse patient-centric approaches to every aspect of a trial, which can spread beyond the US and be embraced by sponsors around the globe.