Clinical trial participants donate their health information so researchers can learn more about the risks and benefits of new treatments. All kinds of personal information are collected during a clinical trial: from genetic sequencing to cholesterol measurements, CT scans to IQ scores. These data are then analyzed by researchers to answer specific research questions. But what happens to individual patient data? Specifically, do participants have the right to own their own clinical research data?
The current state of patient data ownership
Patients sometimes try to obtain data from studies they have 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 – usually pharmaceutical companies or universities.
In the US, federal rules don’t actually block study participants from getting their test results. However, the whole topic of patient access to data is usually avoided or simply non-negotiable. Recently, however, there has been a trend towards patients gaining 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, rather than going through doctors. For example, the 1 million American volunteers participating in the Precision Medicine Initiative will have access to everything scientists learn about them, from gut bacteria to DNA reading. “To promote open data sharing,” says the National Library of Medicine“Participants have access to their health information, as well as to research that uses their data, during the study.”
There are currently several pieces of legislation, such as the new European General Data Protection Regulation, which state that patients generally have the right to receive their raw data. But there is a catch. The procedural application of this right and whether it includes genetic counseling is at the discretion of Member States. In the 2017 peer review summary Return of genomic sequences to research participants: Policy and practice, Wright et al. stated that the UK’s 100,000 Genomes Project protocol guarantees 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 target regions of DNA or RNA or entire genomes — is used more in clinical research, it is likely that even more study participants will want access to their data. But what does this mean in practice?
There is a wide range of opinions on whether patients have a right to their clinical data, including their genomic data. As clinical research moves toward open science, not everyone agrees where patients’ rights to their data fit. Fortunately, there is a growing amount of support for research participants to more easily access their raw genomic data in a research context.
The risks of patients owning their data
It is important to understand the ultimate goals of clinical investigators and study participants may be at odds. Researchers may have their own reasons for keeping data locked away—perhaps to protect grants, publications, or intellectual property. Meanwhile, study participants are usually looking to improve their own health or improve medical science.
Other risks include accidental “disclosure” of research. Sponsoring pharmaceutical companies may fear jeopardizing a study by sharing individual data, since participants could theoretically share it with each other and find out who is in the active drug versus placebo group. This is particularly true for rare disease groups, where support groups and information sharing (eg, patient support group on Facebook) are common among patients in search of a cure.
But this in itself is not a reason to restrict participants’ access to their own data. Instead, sponsors could place some rules and conditions around access, including a measure of participant accountability, to protect the integrity of the trial. In fact, it may be best to share individual data with participants only after the survey results. Of course, patients may be reluctant to wait until publication—especially if there is a sense of urgency in resolving their health crisis. However, participants will be required to agree to a time-limited non-disclosure agreement to prevent their data from being disclosed to avoid risk of bias, influencing regulatory authorities and jeopardizing the integrity of the process.
Participants as partners, not subjects, in studies
The clinical research industry needs to rethink access to participant data in 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 communicating trial results and offering access to a subset of their own data. This can pave the way for participants to become partners in clinical research and take ownership of their clinical research data. In the near future, every citizen may have their own personal, digital health record to which they can control access. From there, people can choose to anonymize some or all of their health metadata and receive invitations to the relevant clinical trials.
Putting data in the hands of participants is an important step in changing the traditional paradigm of clinical trials. It fits in with the goal of conducting agile and patient-centered studies. But without legislation, it’s doubtful that drug companies will give up ownership of participants’ data out of sheer goodwill. And as we see more and more business models built on monetizing patient data, it becomes increasingly 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 participants in clinical trials, not fewer. It is up to us to create safe and effective ways to share this critical data with participants who want it.