MedCity Influencers, BioPharma

Should Patients Have the Right to Own Their Clinical Trial Data?

Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm. It fits in amongst the goal of running nimble and patient-centered studies. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill.

Participants in clinical trials donate their health information so researchers can learn more about the risks and benefits of new treatments. During a clinical study, all kinds of personal information are collected: from genetic sequencing to cholesterol measurements, CT scans to IQ results. This data is then analyzed by researchers to answer specific research questions. But what happens to a patient’s individual data? More specifically, do participants have the right to own their own clinical research data?

The current state of data ownership for patients 

Patients sometimes attempt to obtain data from studies they participated in, but are usually told that the data cannot be shared. Data collected during clinical trials are usually owned by the study sponsors who paid for the study to be conducted—typically pharmaceutical companies or universities.

In the US, federal rules don’t actually block study participants from getting their test results. Still, the entire topic of patient access to data is usually avoided or just not up for negotiation. Recently, however, there has been some traction in patients getting access to their own data. In 2014, the FDA amended the Clinical Laboratory Improvement Amendment of 1988 to give patients direct access to data when requested, instead of going through physicians. For example, the 1 million American volunteers taking part in the Precision Medicine Initiative will get access to everything scientists learn about them, from gut bacteria to DNA readouts. “To encourage open data sharing,” says the National Library of Medicine, “Participants can access their health information, as well as research that uses their data, during the study.”

Currently, there are several legislations, such as the new European General Data Protection Regulation, which state that patients do in principle have the right to receive their raw data. But there’s a catch. The procedural implementation of this right, and whether it involves genetic counseling, is done at the discretion of the Member States. In their 2017 peer review summary Returning genome sequences to research participants: Policy and practice, Wright et al. stated that the UK 100,000 Genomes Project Protocol warrants patients the right to request that their whole genome sequencing data be made available to them.

As next-generation sequencing (NGS)—used to determine the order of nucleotides in targeted regions of DNA or RNA or entire genomes—is used more in clinical research, it’s likely that even more study participants will want access to their data. But what does this mean in practice?

Varying opinions

There is a wide range of opinions on whether patients have the right to their clinical data, including their genomic data. As clinical research moves toward open science, not everyone agrees on where patients’ rights to their data fit in. Fortunately, there is a growing amount of support for research participants to have easier access to their raw genomic data in research contexts.

The risks of patients owning their data

It’s important to understand the end goals of clinical researchers and study participants might be at odds. Researchers may have their own reasons to keep data locked up—perhaps to protect grants, publications, or intellectual property. Meanwhile, study participants are usually looking to improve their own health or further medical science.

Other risks include accidental “unblinding” of a study. Sponsor pharma companies may fear jeopardizing a study by sharing individual data since participants could theoretically share it with each other, and figure out who is on the active drug arm versus placebo. This is especially true for rare disease groups where support groups and information sharing (e.g., Facebook patient support group) is common among patients on the quest for a cure.

But this alone isn’t a reason to restrict participant access to their own data. Instead, sponsors could place some terms and conditions around access, including a measure of participant accountability to protect trial integrity. In fact, it may be best to share individual data with participants only after the outcome of the study. Of course, patients may not be keen to wait until after publication—especially if there is a sense of urgency in solving their health crisis. However, participants would need to agree to a time-limited non-disclosure agreement to prevent divulging their data to avoid risking bias, influencing regulatory authorities, and jeopardizing the integrity of the trial.

Participants as partners, not subjects in studies 

The clinical research industry needs to re-examine participant data access under the context of increased data sharing, interoperability, and transparency. Because clinical research is done with willing participants, they should be treated as partners. This includes proactively informing them of trial results and offering access to a subset of their own data. This can pave the way for participants to become partners within clinical research and take ownership of their clinical research data. In the near future, each citizen could have their own personal, digital health record, to which they control access. From there, individuals could choose to anonymously expose some or all of their health metadata and receive invitations for relevant clinical trials.

Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm. It fits in amongst the goal of running nimble and patient-centered studies. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill. And as we see more business models built on monetizing patient data, however, it becomes ever more important that clinical research participants are compensated with access to their own data. Withholding this data may actually deter patients from participating in future trials—and we need more willing clinical research participants, not less. It’s up to us to create safe and effective ways to share this critical data with participants who want it.


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Derk Arts

Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform, that helps them maximize the impact of research data on patient lives.

Dr. Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. 

Over the past 12 months, Castor provided pro-bono support to over 300 Covid-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.

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