Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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5 Building an Infrastructure to Support Clinical Trials
5 Building an Infrastructure to Support Clinical Trials
Pages 53-62
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From page 53... ...
In previous and ongoing Forum discus sions, many participants in Forum activities have suggested that efforts to develop a consistent and reliable clinical trials infrastructure that lived beyond the single trial could increase the efficiency and effective ness of the entire CTE. Individual workshop participants described major infrastructure deficits and practical ideas for shoring it up and converting weaknesses into strengths.
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From page 54... ...
; Ellen Sigal, Friends of Cancer Research; and Janet Woodcock, Center for Drug Evaluation and Research, FDA Clinical trials in the United States have become too expensive, difficult to enroll, inefficient to implement, and ineffective to support the development of new medical products, or the clinical effectiveness of these products, under modern scientific standards of evidence. This critique is expressed in the Discussion Paper prepared by Paul Eisenberg, Amgen Inc.; Petra Kaufmann, Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS)
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From page 55... ...
In the study, at least five organizations -- a pharmaceutical manufacturer, the Cystic Fibrosis Foundation Therapeutic Development Center, NIH, and two British entities -- funded a multisite RCT of a drug that increases the effectiveness of the CF transmembrane conductance regulator protein; the study found substantial improvements in weeks 2 through 48 (Ramsey et al., 2011)
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From page 56... ...
. Issues currently under consideration in review of the Common Rule include mandating a central IRB for multisite domestic studies; informed consent for future use of bio-specimens for research purposes (along with harmonization of Common Rule and HIPAA requirements on this subject)
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In short, too often there is no rational business model for developing evidence to support clinical guidelines, utilizing the dedicated services of a stable cadre of researchers within a single institution. Fiore, Jolly, and Margolis described the evolving and promising research capacity, built around large patient populations, of the VA, PACeR, and HMO (health maintenance organization)
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Other VA advantages in conducting research include a large and stable patient population; a model EHR system, coupled with secondary use of data to identify patients meeting particular research criteria; and a secure clinical data warehouse (VA Informatics and Computing Infrastructure, or VINCI)
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From page 59... ...
SOURCE: Jolly, 2011. Presentation at IOM workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda R02159 for 2020.
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During the discussion following panelist presentations, Marissa Miller, NHLBI, NIH, noted the success of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) , a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure.
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From page 61... ...
. Insufficient • esign clinical trials that are appropriate and attractive from D engagement and a patient's perspective -- consider outcomes meaningful to participation in the patient population and society; clinical trials by • ecruit participants through online networks; R community health • rovide patients with standardized information on clinical P care providers and trials, and develop a participation card similar to organ the public donation cards; • eb-based clinical trials that facilitate participation W nationwide; • lert clinicians when a patient meets criteria for A participation in a trial, using EHRs and clinical trial identifiers; and • ncreased encouragement and advocacy of participation in I research by professional medical societies.
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From page 62... ...
SOURCE: This table is based on comments made by individuals participating in workshop discussions and the presentation of the Discussion Paper: Eisenberg et al, 2012. Developing a Clinical Trials Infrastructure.
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