The Association of Clinical Research Organizations is asking the FDA to take every possible opportunity to encourage adoption of new clinical trials technologies, including through public statements, guidance documents, position statements and regulations.
They specifically singled out risk-based monitoring, eConsent, wearables, social media for patient recruitment and real-time trial data analytics, after a new survey showed these areas would be playing a critical part in the future of clinical trials.
"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 Vice President, Policy & Public Affairs at ACRO. "But the biopharmaceutical industry is heavily regulated so there are several areas where we are requesting that the Food and Drug Administration consult with stakeholders and provide additional guidance to encourage the adoption of these exciting technologies."
Lewis said in a press release that the FDA has already provided guidance on risk-based monitoring and eConsent and the industry has been actively implementing these tools and technologies.
The association's survey, which formed the basis of ACRO’s comment to the FDA’s public docket, “Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs,” was administered by Industry Standard Research.