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FDA Program to Share Patient-Reported Data from Cancer Trials

June 23, 2020, 11:57 PM

The U.S. Food and Drug Administration announced a new pilot program Tuesday to share information on symptoms patients report while undergoing clinical cancer drug trials.

Project Patient Voice, an initiative from the FDA’s Oncology Center for Excellence, will feature a public website making available the data from patients taking part in cancer trials. The information will be voluntary submitted by companies that conduct the trials, according to a press release from the agency.

“The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development. Where patient-reported symptom information is collected rigorously, this information should be readily available to patients,” said FDA Principal Deputy Commissioner Amy Abernethy in the release.

Patient-reported outcome (PRO) data is gathered using questionnaires that patients complete during clinical trials, capturing information related to the frequency, and the severity of symptoms when undergoing treatment.

Accessible Information

While patient-reported data has been historically analyzed by the FDA, it is not generally included as part of product labeling and is mostly inaccessible to the public.

The website will have information related to symptoms prior to the start of treatment and into the first six months of the clinical trial, according to the agency.

It will provide awareness into side effects not currently available in the FDA safety tables. It will also identify a subset of patients without a specific symptom prior to the clinical trial.

AstraZeneca PLC is the first company to provide this type of information for their approved products, the FDA said.

“We encourage sponsors to collect this data systematically and look forward to welcoming additional sponsor collaboration as we work to help further serve the patient community,” said Paul Kluetz, deputy director of the OCE, in a statement.

The FDA will co-host a virtual workshop along with the American Society of Clinical Oncology on July 17 to seek feedback regarding the project.

To contact the reporter on this story: Ralph Chapoco in Washington at

To contact the editors responsible for this story: JoAnn Goslin at; Meghashyam Mali at