Industry group calls for FDA guidance on use of wearables in clinical trials
May 11, 2016 – WASHINGTON. A rapid increase in the use of wearable technology and an upsurge in social media for patient recruitment are two of the more prevalent clinical trial technology trends, according to a new survey from the Association of Clinical Research Organizations (ACRO).
“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. We thank the FDA for requesting input on this issue.”
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. 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. ACRO’s members have invested in developing a variety of real-time clinical trial data analytics platforms which are supporting risk-based monitoring, adaptive trial designs and other innovations.
“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.”
The 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.
Source: Association of Clinical Research Organizations (ACRO)