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Data Interoperability in Clinical Trials Will Help Put Patients First

The FDA wants to improve diversity in clinical trials as it outlined in new draft guidance open for public comment.

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Curtis Minor is taking part in the SPRINT study at Downtown Health Plaza, an outpatient clinic of North Carolina Baptist Hospital in Winston-Salem. Photo Credit: Photo Credit: Wake Forest School of Medicine

The Food and Drug Administration (FDA)’s newest diversity action plans for drug and device manufacturers announced a draft guidance prioritizes diversity in the later stages of clinical trials, a first step toward fulfilling requirements in the Congress’ Food and Drug Omnibus Reform Act (FDORA) passed in December 2022.

According to the guidance, the plans must include the sponsor’s goals for enrollment in the clinical study, disaggregated by race, ethnicity, sex and age group of the relevant study populations. Farid Vig, CEO and founder of Citizen Health, said the relationships between sponsors, patients, researchers and clinicians need consistent collaboration.

“There’s such promising technology, but you need years and years of follow-up after the study. Sponsors say we have no idea how to do that, and they drop the program,” Vig said.

Clinical trial sponsors must also give a rationale for the goals of the trials and explain how they intend to meet them. ARPA-H director Renee Wegrzyn described how her agency plays a role in clinical trials, despite not being a traditional partner. The agency, she said, will act as a voice for the customer and advocate for better customer experience and health outcomes in research.

Wegrzyn pointed to the ADvanced Analysis for Precision cancer Therapy (ADAPT) program as an example of advocating for customers to be heard. Patients’ tumors change or become resistant to treatment over time, but changes to the treatment plan are not commonly driven by tumor biology data.

“[ADAPT allows] rethinking of how you have a clinical trial that adapts along with the patient as their tumors adapt. You would think that would be a common practice, but it isn’t,” Wegrzyn said.

National Coordinator for Health Information Technology and Department of Health and Human Services Acting CAIO Micky Tripathi said public-private partnerships will be crucial to data interoperability. Tripathi also noted that a final rule related to information blocking made June 24 in the 21st Century Cures Act requires provider organizations “to share all electronic health information with other authorized parties, including for research.”

“We can’t do this without public-private engagement. That’s in everything from the standards that we work on together … to the nationwide interoperability networks that require private participation,” Tripathi said.

Wegrzyn also highlighted the importance of maintaining partnerships between patients, clinical trial centers and others. Wegrzyn said building relationships can help leave an infrastructure for the future.

“We may work with one center for an osteoarthritis trial, but the next time we work with that center might be for a cancer trial,” Wegrzyn said. “By really planting those seeds to create a routed network we, as an agency, can use well into the future after my term limit is up.”

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