FDA Official Reviews “Challenges and Obstacles” to Decentralized Trials

Calling it a “timely conversation,” Eric Pittman, director of the Bioresearch Monitoring Division at the U.S. Food and Drug Administration (FDA), told attendees of the second day of the ACRP 2021 virtual conference’s opening block of sessions yesterday (January 13) that the agency is enthusiastic about how decentralized clinical trials (DCTs)—in one form or another—may increase patient participation even as they reduce costs.

However, Pittman’s weather report wasn’t all blue skies and sunshine. “There are definitely challenges” when it comes to implementing and regulating DCTs, he added.

Noting that the COVID-19 pandemic had accelerated usage of DCT components, Pittman listed several “perceived and/or actual benefits” of DCTs, including:

  • More efficient clinical trials at lower costs
  • Accelerated enrollment and increased diversity
  • More frequent measurement
  • Reduced time and travel burdens for participants

At the same time, Pittman warned there were still issues to be worked on regarding DCTs, including:

  • Immature digital infrastructure in some parts of the U.S.
  • Perception of regulatory barriers
  • Highly varied state laws and regulations
  • Consistency in protocol execution
  • Data reliability and integrity

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Pittman told sponsors they should “establish processes, procedures, and training communications” for handling DCTs, and should conduct “timely review of critical data and follow-up of potential compliance concerns.”

He offered sponsors other tips to successfully leverage DCTs, including:

  • Ensure key parties are included in site initiation and training
  • Use a risk-based approach to monitoring
  • Leverage central monitoring
  • Involve monitors, data management staff, and statisticians to review and analyze data early and often
  • Communicate across sites effectively
  • Establish the process and procedures for review and handling of source data

At a separate ACRP 2021 session later in the day, ACRP Executive Director Jim Kremidas moderated a panel of thought leaders who shared their in-the-trenches experiences leading clinical trial teams last year through a global pandemic.

“Change management is still an issue,” said panelist Jennifer Sheller, regional head of North American Clinical Trial Country Operations at Merck. Thinking back to early 2020, Sheller noted many on her team and elsewhere were “overwhelmed and struggling to keep up.”

Merck leaders responded by holding numerous informational meetings for staff, and offered up subject matter experts with regular office hours so staff could reach out with questions about how the company was pivoting to maintain its trials under the duress of COVID-19. “The meetings were effective and well attended,” Sheller said.

For Asha Collins, head of U.S. Country Clinical Operations at Genentech, 2020 was the year that demonstrated the need for Genentech to be able to handle projects asynchronously to adapt to personnel’s evolving schedules and at-home demands in the unchartered territory of working mostly from home. “I think the pandemic has shown the need for clinical trial professionals to be comfortable with technology,” she said.

Looking ahead, Collins believes clinical trial workforce roles will become more fluid, job titles will change, and there will be a demand for practitioners to become better at data analytics.

Author: Michael Causey