ACRO wants updated FDA guidance on wearables, SM use in trials

FDA sign

The Association of Clinical Research Organizations (ACRO) has asked the FDA to update its official guidelines to help CROs and other sponsors make better use of new tech and sharing platforms in clinical trials.

This comes after ACRO, which represents major contract research groups, released a survey showing that the increase in the use of wearable technology (with a focus on health monitoring) and an upsurge in social media for patient recruitment are “two of the more prevalent clinical trial technology trends.” The FDA had asked ACRO for its input on these issues.

Based on the survey of stakeholders in the industry, ACRO is now asking that the U.S. regulator to:

  • Issue a public statement that the use of new technologies is encouraged in clinical trial conduct
  • Create a task force to work with sponsors, CROs, patient groups and technology providers and healthcare providers to learn first-hand the barriers and benefits
  • Plan to adjust current guidance documents to allow for use of these technologies, as many guidance documents were written for a paper process, not technology-driven solutions.

On top of this, ACRO said that the FDA “needs to provide clear guidance in terms of how to proceed related to security and monitoring requirements related to these new technologies,” as well being willing to share the progress being made in the industry, and provide feedback on the use of new technologies and inspection results.  

"ACRO members are at the forefront of developing and implementing new clinical trial technologies to enhance efficiency and improve the patient experience," said John Lewis, senior VP of policy and public affairs at ACRO.

"But the biopharmaceutical industry is heavily regulated so there are several areas where we are requesting that the FDA consult with stakeholders and provide additional guidance to encourage the adoption of these exciting technologies.”

Other areas where ACRO members identified substantial benefit/increase in adoption were: risk-based monitoring; electronic informed consent (eConsent); and the use of near real-time trial data analytics, according to the survey.

Lewis noted that the FDA has already provided guidance on risk-based monitoring and eConsent and the industry has been actively implementing these tools and technologies.

"Individually, these technologies will have a positive impact on clinical trial efficiency," said Lewis. "But collectively they can help bring about a much more productive process for research sponsors, CROs, sites and patients."

- check out the release