Updated on 11 February 2016
A three-part video series focusing on the role of data in clinical trials has been released by the Washington-headquartered Association of Clinical Research Organizations (ACRO) that examines the definitions and uses of ‘real world ACRO slated the release of the videos to coincide with a national health policy conversation revolving more and more around ‘the cancer moon-shot', personalized medicine, ‘big data', innovation, and the search for 21st Century Cures.
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics, and medical devices. The Association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more than 110,000 professionals worldwide and conduct research in 142 countries.
"Clinical research organizations are uniquely positioned to discuss the topic of real world data because our members are increasingly involved in the drug development process from the very early stages all the way through the approval process, reimbursement strategies and the post-approval monitoring of drug safety and effectiveness," said John Lewis, Senior Vice President of Policy & Public Affairs at ACRO. "We certainly hope to inform the Senate as it begins serious deliberations on its Innovation for Healthier Americans initiative, but recognize that the topic of real world data has global implications for healthcare."
The three-video series examines:
The sources and uses of real world data, including registries, electronic health records (EHRs) and claims data; How real-world data influences market access and reimbursement strategies;
Regulatory uses of real-world data in areas such as product approvals, adaptive licensing, and drug safety The videos feature several subject matter experts from ACRO member companies, such as: Michael Pollock, Vice President of Real World Outcomes at PPD; Stella Blackburn, Vice President of Real World and Late Phase Research at Quintiles; Mukhtar Ahmed, President of eClinical Solutions at Bioclinica; Michael Brooks, Executive Vice President at PRA Health Sciences; and Nayan Nanavati, President of Post Approval Services at Bioclinica.