Public Engagement and Partnership

•      Recognize patients as partners in transforming clinical trials. Consider virtual clinical trial models that use mobile and web-based technologies to conduct clinical trials so that participation in a clinical trial is not dictated by geographic proximity to a trial site.

•      Engage the public in order to obtain sufficient and sustained support of the CTE, through both participation in trials and general recognition of the value of clinical research.

•      The public and policy makers often do not see how research leads to better out comes and savings. Creating national awareness of the linkages between clinical research, medical breakthroughs, and ultimately improvements in patient care will require effective communication strategies developed in partnership with the clinical research community and the public.

•      Consider implementation of a default consent or “opt-out” process for participation in some types of clinical research. Default consent would create a legal presumption that the patient agrees to allow use of his or her deidentified record for research purposes.

•      Undertake communication efforts to the public by the research community to pave the way for direct-to-patient research and the use of social media to recruit individuals into community-based models of research, perhaps eventually supplanting the traditional academic model of Phase III clinical trials.

•      Involve patients, the public, practitioners, and payers (including, for example, pharmacy benefit managers) more heavily in conversations about CTE transformation. A new lexicon may be needed to facilitate communication between researchers and the public.

Regulatory Environment

•      Improve understanding and communication between government regulators and research organizations.

•      Ease the regulatory environment when appropriate, in order to reduce the duration and cost of trials and make them more feasible, especially in domestic settings.

•      Update the Common Rule to facilitate fit-for-purpose, patient-friendly repositories of patient data and randomized research projects, especially involving biomarkers and the development of personalized medicine.

Cultural and Financial Incentives

•      Undertake the “creative destruction” of old clinical trial business models in favor of newer business models that complement advances in technology.

•      Encourage academic health and science centers and research organizations to move beyond provincial systems in favor of greater efficiency for the CTE (e.g., legacy systems, such as site-specific IRBs in favor of using a centralized IRB model).

•      Create template contracts to streamline collaborations and subcontracts.

•      Consider the role of CMS in CTE transformation. Should tasks associated with bridging the divide between clinical research and clinical practice become a component of Accountable Care Organizations (ACOs)? Should new incentives be created to spur the sustained and collaborative participation of ACOs in research?

•      Correct disincentives for research, by using more coverage under evidence development (by private payers as well as Medicare) and reimbursing the routine care costs of research participants.

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