Photograph by Jonah Comstock

“Any day now” is today: Pfizer pioneers individual data sharing for US clinical trial participants

At DPHARM 2023 in Boston, Pfizer announced that it has taken the first steps towards sharing clinical trial participants’ own data with them – something participants have sought for years.

In healthcare, there are a few problems that everyone from – hospitals to insurers to pharma – can relate to, and one of those problems is data silos. There’s a huge amount of data on patients locked away in the vaults of each of those stakeholders, and for reasons that range from business competition to patient protection, it’s often not possible to share that data, even when doing so might help patients.

And, ironically, the people with the least access to data are often the patients themselves. After long campaigns, patients are starting to have the right to access clinical notes about them and to download their EHR data, but there’s still a lot of data out there that defies the cry of the patient advocate, “Nothing about me without me!”

“Our clinical trial participants have been demanding it of us, and they have been doing it for years,”

This lack of access to one’s own data is especially egregious for patients who choose to give their time and energy to participate in a clinical trial, yet might never know something as basic as whether they were in the placebo group, much less have access to the data collected at study visits, which could be useful to their primary and specialty care providers.

“Our clinical trial participants have been demanding it of us, and they have been doing it for years,” Pfizer’s enterprise clinical trial data sharing lead, David Leventhal, said recently at DPHARM 2023 in Boston. “And it’s been a story of ‘any day now’.”

At the event, Leventhal announced that Pfizer is making individual clinical trial data available to patients in the United States 12 months after their study completion date, starting this past July.

“We have allyship with our clinical trial participants,” he said. “How can we reject their demand that they have to access their data, to be able to take that data with them, so that they can have a discussion with their treating physician, so that they can continue their care? That’s what they’re asking of us. And we have to answer.”

Mock up courtesy of Pfizer

A matter of trust

For Pfizer, giving clinical trial data back to patients is not just about convenience but also about their overall relationship with participants.

“Trust is everything when it comes to clinical trials and trust is important to the 100,000 participants who have volunteered for our trials and the 6,000 investigative sites that we work with each and every day,” Judy Sewards, head of clinical trial experience at Pfizer, said in another DPHARM presentation. “And so when we start to think about building an experience through trust, it really starts with walking in the shoes of our participants and really listening and learning from their experiences.”

Leventhal also sees patient data sharing as part of a larger, important relationship between Pfizer and its participants.

“This is how we build trust, right?” he said. “How is anyone going to want to be a clinical trial participant if there’s no trust, if there’s no sense that these individuals are looking out for me? Their primary interface is the principal investigator. That person feels like they care about me. But does the sponsor of the study care about me? This is our chance to show that we can, and we do.”

“Our participants want to know what happened, how  what they did contributed to make a difference; what was learned, how they potentially contributed to a new breakthrough.”

The company also recently launched Pfizerlink, a clinical trial registry that makes it easier for participants to find and enrol in a study in the first place. But Seward believes building trust and providing strong patient experience needs to extend through the whole trial journey.

“We make every effort as we begin a trial and end a trial to welcome participants, but also thank those participants who have volunteered because, without them, new medicines and vaccines are not possible. One example that we really are proud of is the commemorative booklet that we brought forward for the tens of thousands of volunteers for our Pfizer clinical trial for COVID vaccine. Much like the polio pioneers back in the day who received a pin for a token of their appreciation and a remembrance of that, we put together something quite similar,” she shared.

But a token of gratitude can seem an empty gesture if a company isn’t also willing to share what it has learned from a trial with the patients who helped them learn it.

“Our participants want to know what happened, how  what they did contributed to make a difference; what was learned, how they potentially contributed to a new breakthrough.” Sewards said.

So, this new offering brings the process and the relationship full circle.

“Ultimately, what we want our trial participants to feel is acknowledged for their participation, understood as they go through the process, safe, and that we’ve done everything that we can do to ensure that they are considered and taken care of,” Sewards said.

The latest step in a long journey

As Leventhal noted, participants have been asking for their data for a long time. But Pfizer hasn’t simply been dragging its feet. The company rolled out its alumni portal in 2015 to establish a way to track and keep in touch with past participants. In 2021, it started making plain language summaries available through that portal, and shortly thereafter moved the summaries out from behind the portal to, where anyone can access them.

“And we do all of this while preserving their privacy and confidentiality.”

“We started this journey ten years ago when we were working around, well, how do we return aggregate results back to participants? Could we return individual data back to participants?” Leventhal said. “We heard about this thing called Blue Button. We played around with that a little bit, and we couldn’t do it because we didn’t have the right investments made in the organisation. Our clinical systems weren’t up to snuff. We didn’t have the infrastructure for a participant to be able to securely gain access to their data. And what we’ve been doing is chipping away and chipping away and chipping away.”

It was important to go slowly in order to maintain trial integrity and protect sensitive health data. But now the company is ready to make the leap, Leventhal said.

“We now can write an R script and extract the data from thousands of patients and load them into individual PDF documents and make them available to clinical trial participants in the alumni community,” he said. “And we do all of this while preserving their privacy and confidentiality. We never know who they are. It’s their participant ID, their site ID, their study ID, and that’s how we match their data up and make sure that the right individual is getting the data. We’re now returning data for every US participant who’s in a Pfizer clinical trial. But this does not mean that we’re doing it for the whole world and that’s what’s coming next.”

Photograph by Jonah Comstock

And a long way still to go

What else is coming next? Well, Leventhal doesn’t believe Pfizer should stop at PDFs.

“PDFs are what participants ask for because that would be the easiest for them,” he said. “But we understand that there’s technology at play and that machine readable formats are requirements to return data in other localities, like in Europe, for example. So we want to return things in the FHIR standard.”

In fact, he wants the data to be available in any format a patient might ask for.

“This is a moral and ethical obligation that we believe that we have.”

“We want to return things in a comma-separated value formula format for those participants who want to actually put their data in the spreadsheet and track it. There was a patient who wanted to do that. He was an engineer and said, ‘I wanted an Excel format, so [I can], you know, track it over time. And graph.’ I was like, ‘Cool, you got it’. And of course, we want to integrate with all the best tools, right? That means Apple HealthKit and the ResearchKit.”

And, finally, this is one area where Pfizer does not want to stand out from the competition. They continue to work with larger organisations, like TransCelerate, the Innovative Medicines Initiative, and the Harvard Multiregional Center for Clinical Trials, to build standards and processes that allow any trial sponsor to make this data available.

“The ultimate goal is that we have to get every sponsor to do this, and we have to do it really, really well. Because, if one of us does a bad job, then we’ve all done a bad job,” he said. “This is a moral and ethical obligation that we believe that we have. But it’s not going to be enough until we’re all doing it and that every participant knows that this is available to them.”

About the author

Jonah Comstock

Jonah Comstock is a veteran health tech and digital health reporter. In addition to covering the industry for nearly a decade through articles and podcasts, he is also an oft-seen face at digital health events and on digital health Twitter.

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