“This is our vision of the future—that individuals will always be at the center of their data.”

That’s the conclusion of Sharon Terry, MA, president and CEO of Genetic Alliance in Washington, DC, who spoke at a National Cancer Policy Forum Workshop, Contemporary Issues for Protecting Patients in Cancer Research, in Washington, DC, in February, the proceedings of which have just been published.1

Data is a single word that encompasses a wealth of information. The collection and analysis of data is a critical component of cancer research, but data collection can come with a price. One of the goals of the workshop was to discuss the best ways to protect patients enrolled in clinical trials and their data.

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Federal regulations to protect “human subjects” participating in research were first implemented nearly 40 years ago, largely “because something awful happened,” said Susan Ellenberg, PhD, professor of biostatistics and associate dean for clinical research at the University of Pennsylvania School of Medicine in Philadelphia, Pennsylvania, said during the workshop.

This included the Tuskegee trial, where some patients with syphilis remained untreated so the natural history of the disease could be documented. Such ethical lapses led to the development of institutional review board review of clinical studies and to requiring patients provide inform consent to research participation.

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Since that time, the landscape has changed: trials are more complex, the use of archived biospecimens and genomics data has increased, electronic health records support “Big Data” collection and mining and, most importantly, patients now have a wide range of views on sharing their data for health research.

The “protection for participants in research” is a phrase preferred to “human subjects protection.” The workshop explored the goal of this protection while highlighting the patient perspective. Discussion centered on perceived shortcomings, including the balance of risks and benefits and the evolution of patient consent forms that now protect institutions and “view patients as liabilities,” according to the workshop report.

“Our goal is to avoid unjustifiable risks, but to allow for uncertainty in order to let patients have access to what they need and what they might benefit from in treating their cancer,” said John Mendelsohn, MD, Director of the Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center in Houston, Texas. “All of us need to do a better job at this and recognize there is no perfection. Perfection is often the enemy of the excellent.”

Deborah Collyar, founder and president of Patient Advocates in Research in San Francisco, California, said patients want individual, understandable results and want to share their data; “however,” she explained “the regulations we have actually thwart that process.”

Currently, registries focus primarily on investigators, institutions, and research sponsors—not patients, Terry said. One proposed solution is to use online, participant-centric registries such as Platform for Engaging Everyone Responsibly (PEER), which gives patients the ability to manage the right to access their health data. PEER is currently used by institutions and organizations that are part of the National Patient-Centered Clinical Research Network of the U.S. Food and Drug Administration’s Patient-Focused Drug Development initiative.

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According to Terry, “PEER not only meets the privacy standards of HIPAA but exceeds them.” Another bonus: clinical trials can search and find individuals registered in PEER. This is timely in that “growing emphasis on targeted cancer therapy requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented,” the workshop report acknowledged.

To help match patients with the 10,000-plus enrolling clinical trials in the United States, a forensic toxicologist and a cancer survivor recently founded CureLauncher.com, a free website for patients, caregivers, and health professionals. Based on a patient’s goal and medical condition, relationship managers can use this website to help find trials and make appointments on a patient’s behalf. Their mission: “that no family will ever lose a loved one without knowing all their new treatment options.”


  1. Institute of Medicine of the National Academies. Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary. Washington, DC: The National Academies Press; 2014.