FDA and Clinical Trials Industry Experts Focus New Attention on Rare Disease Studies

With the recent launch of the U.S. Food and Drug Administration’s Rare Disease Endpoint Advancement Pilot Program, the clinical research enterprise gains new support for efforts aimed at efficacy endpoint (or clinical outcome) development and the timely approval of drugs and biological products that treat rare diseases, including rare diseases in children.

More Than Just the Right Words: The Importance of Translations in Clinical Research

In recognition of National Hispanic Heritage Month and the importance of clear communications between study teams and participants in clinical trials, no matter what their native languages may be, ACRP reached out to Emi Pell, Head of Sales and Marketing (Global) at Conversis, and Cassandra Andrade, Director of Strategic Accounts - Trial Interactive at TransPerfect and Brand Ambassador for Latinos in Clinical Research, to discuss careers and challenges related to translating study documents for patients.

Decentralized Clinical Trials in a Post-Pandemic Era

Decentralized clinical trials represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. During the COVID-19 pandemic, the clinical industry experienced significant disruption to traditional practices. To mitigate the spread of coronavirus, officials executed temporary guidance that limited person-to-person contact and forced many on-site physical clinical trials to a halt.

It’s Time to Pay More Attention to Pain Research and Management

As stakeholders in pain research and pain management across the U.S. observe Pain Awareness Month this September, an ACRP Fellow and long-time volunteer is among the voices calling for more attention to be aimed at this vital but often-overlooked area of healthcare.