New FDA Platform Criticized for Lack of Demographic Information

The new FDA platform Project Patient Voice, is a public database of patient-reported outcomes for clinical trials of cancer treatments intended to give patients with cancer and their physicians a way to access these data for decision making. Launched in June, there is only one study published on the project’s pilot website, but as health care experts noted in STAT, the interface does not allow users to access demographic information about trial participants. The website also lacks the capability to break down the data according to characteristics like age, gender, or race.

Vishal Bhatnagar, MD, an oncologist at the FDA who worked on the platform, said the agency decided against including demographic breakdowns to avoid redundancy since that information is available on Drug Trial Snapshots, another FDA platform that provides clinical trial data.

According to Rob Carlson, MD, Chief Executive Officer of the National Comprehensive Cancer Network, leaving demographic information off of the platform may avoid redundancy, but also makes the website less usable for the patients.

“It’s ‘Patient Voice’ but it’s not in patient language,” said Dr. Carlson. “This is information from patients for patients to patients, but it’s not written in that way.” He added that patient-reported outcomes are expected to differ by ethnic group, age, employment status, and other demographic factors – information that will be important in interpreting trial data.

Dr. Bhatnagar confirmed that the FDA is continuing to develop Project Patient Voice and will host a public workshop in mid-July to discuss feedback on the site.

Sources: STAT, July 1, 2020.