Clinical Trial Volunteers Gain Access to Their Own Test Results: A Blessing or a Burden?

Generally speaking, if you volunteer to participate in a clinical trial, your body will be subjected to various pokes, pricks, scans, and analyses. Yet, after undergoing this process, it is highly unlikely that you will receive any of your test results.

A small yet highly influential team has been working to change this status quo and is beginning to attract widespread attention.

GeneralThe research institution opposes granting volunteers access to their test result data., although volunteers participating in clinical trials should be considered part of the trial. Some people worry that many volunteers are laypersons who may easily misinterpret or overinterpret test results, while others believe that allowing these volunteers to access the data independently is a waste of resources.

But now there has been a significant shift in the industry, as two global pharmaceutical manufacturers recently agreed to allow clinical trial participants to access data derived from their own bodies. This July, the federal agency responsible for overseeing human research recommended that data sharing in clinical trials become the norm rather than the exception.

Therefore, it is expected that tens of thousands of people will sign up for the large-scale federal research initiative known as the “Precision Medicine Initiative,” as participants will receive access to all information at the same level available to scientists, including DNA records and data on the billions of bacteria residing in the human gut.

Dr. Eric Topol, a cardiologist and director of the Scripps Translational Science Institute, said, “This is a shift in power,” but it remains to be seen how volunteers will use these data, or even whether they want to know their own data.

In two diabetes clinical trials in 2013,Pfizer has established online accounts for U.S. volunteers, primarily to enable them to freely download their electrocardiogram (ECG) charts, laboratory reports, and vital signs measurement data after the study concludes.. The statistical results indicate that fewer than 15% of the volunteers downloaded the relevant data.

Craig Lipset, Head of Clinical Innovation at Pfizer, stated, “We have found that while patients generally express a desire to access their own data, the final click-through and download rates indicate that few actually do so. Therefore, I am uncertain whether these patients have sufficient time and capability to leverage this data for meaningful purposes.”

However, Craig Lipset believes that companies can boost volunteers’ interest in understanding the data by adjusting when and how they access it, as well as what information they are exposed to.

Janssen Pharmaceuticals is currently conducting research on experimental drugs for rheumatoid arthritis. Volunteers can access real-time laboratory data and decide whether to upload it to their electronic health records. At the trial sites, 24% of volunteers chose to upload their data, with 38% of them regularly using the system.

Dr. Koester, Vice President of Research and Development at Janssen Pharmaceuticals, regarded the aforementioned incident as a low-probability event; nevertheless, he did not intervene to prevent it, with the aim of facilitating the collection of post-use feedback from volunteers for such systems.

The message this sends to the industry is: “This is a black box. If patients provide us with all their information, but we cannot share any feedback with them, such an approach will be unsustainable.”

Proponents of this initiative argue that returning data to volunteers can enhance public trust in such scientific research and increase participation. Furthermore, it can reduce the redundancy of medical testing, empower participants to proactively manage their health data, and encourage greater data sharing among scientists.

Jack Whelan, 67, has a clearer objective in this regard: he believes that access to his own data is crucial to his survival.

Over the past eight years, Jack Whelan has participated in seven clinical drug trials aimed at finding treatments for blood cancers. This month, he began his eighth clinical drug trial following a new diagnosis of advanced prostate cancer.

From the outset of his first trial, Whelan told his research physician, “I want all the data you collect.” He then organized the acquired data into a spreadsheet to track his body’s response to each experimental drug. Although Whelan lacked a medical background, his prior experience as a research analyst made him highly attuned to data.

He quickly learned how to determine whether an experimental drug was effective for him, generally by observing changes in his blood levels of creatinine, bilirubin, and other markers. Participants in clinical trials are not supposed to know whether the drugs are working for them. However, Whelan’s condition necessitated assessing the trial’s efficacy through data. “If after two or three injections I see no positive effect, I think I would stop the trial,” said Jack Whelan.

Such stories have kept researchers cautious; if volunteers conclude, based on their own data, that the drug trial they are participating in is ineffective, they may choose to withdraw, thereby compromising the reliability of clinical trials. This issue is also significant for Jack Whelan, although he is more concerned about his own life. He believes that analyzing his personal health data has been particularly useful; otherwise, it would have been impossible for him to sustain his life for so long while battling such a fatal disease.

Therefore, to enable others to receive similar assistance, Jack Whelan and his collaborators developed an application and information service platform to help patients manage their health records, including clinical trial data. The team sold this platform to ERT, a clinical trial software company, which is currently integrating it with its own systems. Meanwhile, Jack Whelan now resides in Andover, Massachusetts, where he serves as a patient advocate, receiving compensation from various pharmaceutical companies for his services.

Others believe that providing volunteers with their own data is the right approach. Laura Kolaczkowski, a 62-year-old patient residing in Ohio and currently a co-principal investigator of iConquerMS—an initiative that enables multiple sclerosis patients to share their data for research—stated, “It is highly unreasonable that this trial requires me to invest my time, contribute my body, and help advance treatment development under circumstances that may compromise my health, yet I still do not have access to my own data.”

Kolaczkowski volunteered to participate in a study on baclofen, a muscle relaxant, but was never informed whether the trial ultimately succeeded or failed. “When this study ended,” she said, “the sponsor of the trial owed something to the participating volunteers.”

In the United States,There is no federal law prohibiting the provision of test results to these volunteers, provided that the tests are ultimately determined to be lawful.。

In fact, the Advisory Committee on Human Research Protections of the U.S. Department of Health and Human Services recently proposed a so-called “rebuttable presumption,” suggesting that researchers should provide study participants with their individual trial results after the conclusion of the research, at least for certain routine tests such as hepatitis viral load and IQ scores. This information need not be demonstrated to be medically significant; the mere curiosity of the participating individuals constitutes sufficient justification for data sharing.

Access to data is typically stipulated in the protocols of participating instruments and detailed in the documents signed by participants at the outset.

Among the research volunteers surveyed in 2014, only 9% received a summary of the study results. Additionally, a survey conducted by a non-profit clinical research organization among 1,072 volunteers participating in information and research centers found that only 4% ultimately learned whether they had been administered an active drug or a placebo.

Some scientists, and even some volunteers, support keeping the vast majority of clinical trial participants blinded.

“I used to think that patients needed all the data, but my thinking has changed,” said Deborah Collyar, a breast cancer survivor, Chair of Patient Advocates in Research, and member of the Research Advisory Committee. “Data is not knowledge. You must first understand the data before you can interpret it. Without proper context, this information is useless.”

Another issue concerning data sharing: Dr. Ellen Wright Clayton, Professor of Biomedical Ethics and Society at Vanderbilt University Center, stated that encouraging volunteers to provide their datasets with the expectation of participating in clinical trials is not an act of pure altruism. This practice blurs the line between research and healthcare, she said, and constitutes a misuse of limited research funds. This is because, after accessing their data, volunteers may misinterpret test results and seek unnecessary treatments or request further testing.

Therefore, Clayton supports strict limitations on returning data to volunteers, arguing that research participants should only be informed of results with potentially serious implications, such as suspicious shadows on MRI (magnetic resonance imaging) scans.

On the other hand, some researchers are attempting to make it easier for study participants to access their own data, thereby empowering them to decide whether they wish to share such data with scientists.

A recent project enables families with rare, undiagnosed genetic disorders to participate in research through the Center for Mendelian Genomics at the University of Washington.Through this study, participants can obtain their genome sequencing results, including the raw data, along with corresponding reports and tools for data analysis.All of these services cost just $825, rather than the $5,000 to $7,000 typically required for hospital-based gene sequencing. Additionally, participants may choose to publicly share this data along with their own medical records if they wish.

Jason Bobe, an associate professor of genetics at the Icahn School of Medicine at Mount Sinai in New York, said thatReturning these data directly to people’s hands is a key step in redesigning the entire medical research system, with the goal of making the research process faster, more equitable, and more accurate in curing diseases.Bobe pointed out that academic researchers, companies, and non-profit organizations have stronger incentives to keep data in their own hands, whether to protect intellectual property, comply with grant requirements, or facilitate publication. In contrast, most research volunteers participate simply to improve their own health or to advance medical science.

Jason Bobe said, “These volunteers do not care about tenure like academic researchers, nor do they care about stock prices like research companies; they genuinely care about the trial results—because these data represent their health and the health of their families.”