Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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4 Creating a New Business Model for Clinical Trials
4 Creating a New Business Model for Clinical Trials
Pages 43-52
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From page 43... ...
, Duke Translational Medicine Institute; and Kevin Schulman, Professor of Medicine, Duke University Medical Center, and Gregory Mario and Jeremy Mario Professor of Business Administration, Fuqua School of Business. (See Appendix F for the Discussion Paper "Transforming the Economics of Clinical Trials.")
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From page 44... ...
Increasing costs stem in part from obstacles that exist within regulatory pathways or stem from administrative inefficiencies, including increasingly complex clinical trial protocols, abundant requirements issued by various levels of government and different governments and not harmonized to ensure consistency, and excessively risk-averse interpretations of regulations by trial sponsors. An example of the last is 100 percent source documentation of all clinical trial data even though regulators -- both FDA and the European Medicines Agency (EMA)
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From page 45... ...
The research agenda would be reassessed every 2 to 5 years to ensure that business and regulatory mechanisms keep pace with technologic advances and other changes in the economic, scientific, and health care environment surrounding the CTE. Suggested pathways and opportunities for moving research business models forward would therefore reflect findings that emanate from a forward-looking research agenda that considers the seamless integration of technology into research.
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From page 46... ...
The adoption of new business models could be facilitated by the engagement of all sectors in the conceptualization of business transformation.2 The uptake of new clinical trial business models could increase return on investment and introduce greater predictability and efficiency as a consistent attribute of the CTE. 2 For example, currently, the CTTI, a collaboration between Duke University and FDA, is undertaking to combine the perspectives of more than 50 stakeholder organizations to develop new approaches and begin to point the way toward a new model for clinical trials.
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From page 47... ...
Thus, large-molecule products in development might require syringes or other devices to be developed simultaneously so that individuals can benefit from these novel therapeutics; • the evolving and somewhat confusing mechanism for reporting adverse events experienced by clinical trial participants (including immediate reporting of "serious" and unexpected events experi enced by participants) ; 3 This section is based on remarks made by Paul Eisenberg, Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc., and the Discussion Paper "Developing a Clinical Trials Infrastructure" (see Appendix G)
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From page 48... ...
Participants included session chair, Arthur Rubenstein, Professor of Medicine, Division of Endocri nology, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania; Richard Rudick, Professor of Medicine and Hazel Prior Hostetler Chair of Neurology, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Christopher Beardmore, CEO, Translational Research Management; and Scott Steele, Director of Research Alliances, University of Rochester. This section provides an integrated summary of their remarks and should not be construed as reflecting consensus or endorsement by the workshop participants, the planning committee, the Forum, or the National Academies.
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From page 49... ...
Patients in trials can incur costs greater than patients in routine health care. Also, rational budgeting of clinical trials by sponsors is impossible without knowing which expenses are research administrative costs, to be paid by sponsors, and which are routine care costs, which may be required to be paid by insurers or patients.
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From page 50... ...
of the Patient Pro tection and Affordable Care Act requires coverage of routine patient care costs associated with clinical trials, with no discrimination against clinical trial participants, by the beginning of 2014. An additional dimension of the reimbursement landscape is the frag mented nature of the U.S.
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From page 51... ...
Dif ferent academic institutions have their own systems, and little interoperability exists. While federal regulators, health care providers, and the IT industry focus primarily on the "meaningful use"4 of EHRs, according to a workshop participant they are not sufficiently investing in connectivity and the use of EHRs in the health care setting for clinical trials.
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From page 52... ...
, is developing common adaptive trial designs. The CTSAs and academic medical centers share training programs, improve common understanding about regulatory requirements, improve informatics, develop model clinical trial agreements, and achieve other infrastructure enhancements across the CTSA institutions.
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