Patient Data Return: Do the Benefits Outweigh the Barriers?

Applied Clinical TrialsApplied Clinical Trials-06-01-2023
Volume 32
Issue 6

Experts explore potential paths to achieving buy-in from pharma and regulators.

What follows is a bulleted list that outlines why pharmaceutical company sponsors should not consider returning clinical trial data to patient participants. In short, it will:

  • take time
  • demand additional people resources
  • call for additional planning
  • require that pharma assume a new mien

In other words, the effort would cost more money, and demand a whole new way of thinking.

What follows is why sponsors should return clinical trial data to patient participants:

  • It is the right thing to do.

This slowly emerging idea of returning trial participants their own data is not ephemeral or whimsical. A few pharma houses are seriously considering eschewing the top four bullets in favor of that stand-alone bullet. One, Pfizer, is just about ready to roll out its own return-the-data program. Another, Janssen, is “actively pursuing” its own version of a patient data-return, a spokesperson said. A few others, all members of the nonprofit collaborative TransCelerate BioPharma, are seriously talking about the matter.

“It is a natural next step for a clinical trial patient,” says Sylvia Baedorf Kassis, program director, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard. Patients, she adds, will want to know, ‘“what can I learn from participating in this study?”’

Sponsors are becoming more comfortable with the idea, according Baedorf Kassis, and for some people, it will make all the difference.

However, she cautioned—like others interviewed for this story—every patient is different, every patient’s need is different, every trial is different. So along with the possible regulatory hurdles that await attention and the significant buy-in from pharma that needs attainment, the data-return supporters have continued working on tools for sponsors to use. The MRCT Center has produced case studies and a patient-friendly glossary of clinical research terms; TransCelerate has made publicly available its resource pack to advise sponsors on returning data; a European consortium has its own project. And, yes, these groups cooperate with one another. (Baedorf Kassis said the glossary has been adopted as a global Clinical Data Interchange Standards Consortium standard.)

A potential selling point to pharma is possible improvement in the historically low trial participant recruitment and retention numbers. In its 2023 omnibus bill, Congress told FDA it wants a diversity action plan with each trial submitted for its review.1 Those interviewed said data return would help in these areas.

At one time, says Christine Lemke, cofounder and CEO, Evidation, “I used to think [the idea] was paternalistic but now I think it is the right decision. Returning the data will take more time.” She adds doing so won’t be easy, but believes it is worth it. “The participants deserve respect.”

Why now

“It was maybe 10 years ago when we started saying there’s something here we have to think about, even though it’s not required” by regulators, Jean Sposaro, director, Global Clinical Trial Industry Collaborations at Bristol Myers Squibb (BMS), tells Applied Clinical Trials. However, not all pharma companies are ready to “take the leap” due to the lack of those requirements.

So why the effort now to create patient data-return plans? “Patient participants are louder than ever,” says Baedorf Kassis. Providing participants with the aggregated results from their trial has not been enough, she argues.

The COVID-19 pandemic, adds Sposaro, put a light on an industry; up until then, pharma had been working behind a curtain, in essence. “Now we’re not,” points out Sposaro. “People know what pharmaceutical companies do and they know that we can’t do it without patients.”

While there always has been a handful of trial participants who wanted their data, “there has absolutely been an uptick in requests for data since the pandemic,” adds Sposaro. “The group of people that I meet with a couple of times a week [regarding patient data return] are all saying the same thing.”

Besides the patients’ desire and appreciation for the value of patient data, “We have the digital capabilities we didn’t have before,” says Sposaro. “So, do we just ignore it or do we start to plan and think ahead?”

Additional hurdles

While the temptation to ask “what happens if this patient wants this or if a genomic test shows that?” is ever present, an interviewer soon learns those kinds of questions are moot. “We’re just beginning to really scratch the surface,” says Sposaro.

“We haven’t gotten there yet, it is so specific,” adds Baedorf Kassis. The MRCT Center, and other data-return advocates, are going with or recommending a phased-in approach, starting with the easiest data to return and thereby gaining experience with the process.

A ‘what happens if’ scenario is discussed anyway. Imagine, says Lemke, that a patient-participant experiences unintended consequences of a data return. Someone needs to walk through the results with them. “You wouldn’t want someone to get that without context,” she notes.

That scenario is exactly what happened to a patient advocate in an MRCT Center case study.2 The woman, a patient with multiple sclerosis, learned that she was at high risk of developing Alzheimer’s disease, but no genomic counselor was provided to help her, and the institutional review board (IRB) said the clinical trial researchers met their contractual obligations.

At this point, these groups are taking the 30,000-feet view. TransCelerate is creating a patient infographic for patient advocacy groups. It is also creating a sponsor-directed considerations guide that will detail “why they should and how that patient data-return could happen,” says Sposaro, explaining that pharma executives aren’t convinced that patients want their data. “What I get a lot from senior leaders is, ‘Do you think patients really want their data?’”

In Europe, a group called Facilitate–which lists 29 pharma houses, academic institutions, patient groups as well third parties–has formed to devise a model plan for patient data return and for the reuse of study data. No two organizations, says Sposaro, have the same goals.

The plan at Pfizer, according to a MRCT hosted webinar3, is to allow patients to receive their data at the end of the trial, which, of course, could take years. The program will begin in US-centered trials for now. Participants interested in getting some data–no imaging files or genomic data just yet–will create an account via a portal.

A few years ago, says Sposaro, BMS ran a pilot study on data return, but at a specific point–when patients failed admission to the trial.

Those failures still result in a lot of data, including blood draws, potential specimens, or imaging results. BMS gave the data back to those patients. She says BMS is now reviewing the outcomes of that data give-back.

Sposaro counted off the benefits to these patients: It lets them move to the next place for their treatment options.

Pharma reduces the burden on the patient, the participant, “but we also reduce the burden on the healthcare system because somebody has to pay for this,” she says. “For me, this is one of the low-hanging fruits. I’m not telling you pharma is doing it yet. I can tell you that we have started to think about it and people are starting to pilot it because that’s just one example of ‘why not.’”

The regulators

Lauren Wu, head of privacy and senior director of legal for regulatory and compliance, Evidation, says sponsors who are interested in returning patient data need to move cautiously from a regulatory perspective. “I would be concerned how this would be interpreted by regulators,” Wu tells Applied Clinical Trials.

Despite the good intentions, regulatory agencies might consider the data returns when accompanied with insights that would make the information understandable to patients as getting “close to practice of medicine considerations or CLIA testing requirements,” says Wu. There are, the attorney adds, “juxtaposed insights, considerations, and conflicts.”

The discussion to return patient data follows a long history of similar efforts by regulators, the government, and others, to share data that emerges from interventional clinical data. At the NIH, its final policy on data sharing among scientists went into effect in January.

The agency wants to see a data-sharing plan before it considers extending a grant–including from its own investigators.4

For the past five years, authors of manuscripts reporting clinical trial results who submitted to a member journal of the International Committee of Medical Journal Editors have been required to include a data-sharing statement.5

But pharma hasn’t exactly embraced the “let’s-share” momentum. One study published last year found that of 61 published trials, nine were considered eligible for sharing data–two years after publication. A study was considered ineligible if it lacked a data-sharing policy or involved an ongoing investigation.6

As for who owns clinical trials data, that argument has multiple sides. It seems that cases can be made for those who funded it, and also for those who provided it.

“Ultimately,” wrote the National Academies of Sciences in 2015, “the question of who owns the data is less important than the question of the rights and responsibilities of data holders.”7

Sposaro says data-return advocates aren’t looking for regulators to tell them what to do, “but what we would like to know is what are the areas that they’d be concerned about.”

The kinks

Lemke highlighted a study Evidation was part of in 2014 with Brigham Women’s Hospital and Atrius Health that demonstrated the good and the questionable regarding patients’ access to their data. The two-arm study involved 411 patients at risk or already diagnosed with high blood pressure.8 Patients used a blood pressure cuff at home. Researchers wanted to see how adherent they would be in taking their medications and using a smartphone app to record their numbers. The upshot: there was some improvement among those patients using the app. These patients were consistent witnesses to their data.

“This is part of the trickiness of sharing,” Lemke tells Applied Clinical Trials. Sharing outcome results could be a confounder that contributes to the
actual intervention.

Other complications, she adds, would be sharing data after an observation period. Those results need to be stored away until they are analyzed.

“People want to lock up data until it is time for statistical analysis and in the hands of regulators for decision-making,” asserts Lemke. “These are complications that pharma hasn’t worked out in order to make [data sharing] a fluid process.”

The trust issue

The public is of two minds regarding their data. A 2018 NEJM study found that of 771 former and current trial participants, fewer than 8% thought the negative reasons of data sharing with scientists outweighed the good reasons.9 The main concerns with sharing data with professionals, the respondents said, was that it would discourage would-be participants in joining a trial (37% “very’ or “somewhat” concerned) and would be used for marketing purposes (34%.)

On the other hand, when the UK’s National Health Service proposed in 2021 that its members’ personal data be shared among various healthcare providers, more than one million people said,
no thanks.10

Returning patient data, says Sposaro, is trust-building. How, she questioned, can industry refer to itself as patient-centered if it doesn’t return the data generated by those people who are helping in the first place?

“We know big pharma is a machine,” she notes. “We’re asking the machine to do something very different.”

Christine Bahls is a freelance writer for medical, clinical trials, and pharma information


  1. Baumann J. Diversity in Clinical Trials at FDA Gets a Boost from New Law. Bloomberg Law. January 19, 2023.
  2. Case Study: Supporting Participant Decision-Making in Genetic Testing Studies. MRCT Center. 2023.
  3. Returning Individual Research Results and Data to Participants: Experience from the Field (Webinar). Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. May 2, 2023.
  4. NIH, Final NIH Policy for Data Management and Sharing (January 25, 2003). Effective date January 25, 2023.
  5. Taichman, D.B.; Sahni, P.; Peiperl, L.; et al. Data Sharing Statements for Clinical trials. BMJ. 2017, 357, 2372.
  6. Siebert, M.; Gaba, J;, Renault, A; et al. Data-sharing and Re-analysis for Main Studies Assessed by the European Medicines Agency—a Cross-sectional Study on European Public Assessment Reports. BMC Med. 2022. 20 (5), 177.
  7. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Committee on Strategies for Responsible Sharing of Clinical Trial Data; Board on Health Sciences Policy; Institute of Medicine. Washington (DC): National Academies Press (US). April 20, 2015.
  8. Morawski, K; Ghazinouri, R; Krumme, A; et al. Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial. JAMA Intern Med. 2018. 178 (6), 802-809.
  9. Mello, M.M.; Van Lieou, B.S.; Goodman, S.N. Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing. N Engl J Med 2018. 378 (6), 2202-2211.
  10. Devaney, S. Research Shows Patients Want More Control Over How their Health Data are Shared. University of Manchester press release. February 2, 2023.
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