Testimony on Comparative Effectiveness Research
John Lewis, Association of Clinical Research Organizations
Oral Testimony of John Lewis, Vice President of Public Affairs,
Association of Clinical Research Organizations
AHRQ National Advisory Council
April 3, 2009
Members of the Council, thank you for the opportunity to speak with you today.
My name is John Lewis. I am Vice President of Public Affairs for the Association of Clinical Research Organizations, ACRO. Our members have 70,000 employees are involved in research in more than 60 countries around the world. Working primarily for pharmaceutical and biotechnology companies that sponsor clinical trials, ACRO companies perform a wide range of activities, from providing assistance with study design through regulatory submission, across the spectrum of clinical trials, from phase I first-in-human studies through phase IV post-market evaluations. In addition to clinical trials, our members' expertise includes: health services research; patient registries; safety surveillance and other public health activities; data management, analysis and reporting, biostatistics; and the topic at hand today, comparative effectiveness research.
I would like to make three points:
First, to generate the maximum impact from the research dollars allocated by the American Recovery and Reinvestment Act (ARRA), we should use as much currently available data as possible as the basis for comparisons between alternative treatments. This includes Phase IIIb and Phase IV studies, that use active comparators, and are reported to the FDA today, as well as a wide range of other data sources; from electronic health record systems to health care claims databases. Head-to-head comparisons of treatment alternatives can be greatly extended and illuminated by these additional data sources, if study designs include appropriate mechanisms for including and analyzing such additional data.
Second, regarding research methods, we recognize that in implementing new trial designs and combining disparate data sources, there is a need for the development of rigorous methodologies and standards. As research organizations that specialize in complex trial design and that commonly aggregate and analyze large amounts of data and report conclusions to regulatory authorities, we would be pleased to be part of the process for establishing those methodologies and standards. We currently participate in the FDA's Clinical Trials Transformation Initiative, the NIH Biomarkers Consortium and several other similar collaborations.
Third, because expertise on CER resides in both public and private entities, every effort should be made to encourage public-private collaboration in the design, conduct, analysis, and reporting of CER. We believe such collaboration should extend to include patients, providers and other stakeholders. We are disappointed, for example, that neither the Federal Coordinating Council nor the IOM Committee includes any industry representation.
As global leaders in clinical research, ACRO members are well suited to aid in the design, conduct and analysis of CER. We stand ready to work with all the stakeholders—pharmaceutical and biotechnology companies, academic and other researchers, patient groups, prescribers, payers, and government agencies—in shaping and executing a CER portfolio that will promote continued innovation in drug development rather than limit it.
The Association of Clinical Research Organizations (ACRO) is the professional organization of companies whose focus is clinical research. The association provides an active voice for the CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. ACRO helps its members improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more than 70,000 professionals worldwide. For more information, please visit http://www.acrohealth.org.