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To date, Quintiles has been the only CRO with representations at events hosted by the House of Representatives Energy & Commerce Subcommittee on Health's 21st Century Cures initiative.
To date, Quintiles has been the only CRO with representations at events hosted by the House of Representatives Energy & Commerce Subcommittee on Health’s 21st Century Cures initiative, focusing on gaps between the science of cures and the way the therapies are regulated. The full background—white papers, videos, meetings, and more—can be found here.
In July, Paula Brown Stafford, MPH President, Clinical Development Quintiles presented at the Modernizing Clinical Trials part of the committees exploration. Today, Rep. Renee Ellmers (R-NC) is hosting a 21st Century Cures Round Table, specifically on the topic of vaccines in Research Triangle Park. At this event, Oren Cohen, MD, Senior Vice President and Global Head of Early Clinical Development at Quintiles, is presenting his recommendations around the gaps in vaccine development and what can be done.
Both Stafford’s and Cohen’s remarks to the subcommittee point to parts of the clinical trials process that have been discussed among industry experts for some time—including IRB delays; technology improvements in data sharing and standardization; and pre-competitive collaborations.
In his remarks today, Cohen specifically takes on IRBs. He states: “Our experience indicates that there is wide variability in the review timelines of among IRBs. Some IRBs review a protocol within days, whereas others take weeks if not months to perform the same task. While IRBs must have the time and experience to properly review protocols, the variability that is observed needlessly delays the initiation of studies.” To address this, Cohen recommends that the FDA require sponsors, when seeking to develop a new product under the Breakthrough Designation, to agree to use only research sites that will either 1) accept mutual recognition for central IRB review of multi-site trials or 2) commit to IRB review within a stipulated period of time, e.g., 30 days.
Cohen also gave a boost to eSource, and specifically speaks to the January 2012 FDA Guidance on Electronic Source Data in Clinical Investigations. He recommends that Congress could encourage eSource Data Capture adoption of by requiring its use in federally funded or supported studies for vaccines. He states that in Quintiles experience, eSource Data Capture in vaccine trials could save time and costs by up to 15%-20%.
With the state of bipartisan politics in this country not exactly showing a record of success, a political focus on discussion of how to improve the conditions of clinical research may not inspire the jaded. But it is interesting to see the discussions and observations of those close to the topic enlightening others about the specific constraints of clinical trials practice.