Uncertainties and risk in planning translational trials

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How do stakeholders define scientific significance and clinical relevance in planning early phase trials? What factors drive decision-making? What are the effects of scientific controversy on trial decision-making? This project examines these questions in the translational medical arenas: cell therapies for Parkinson’s disease and drugs targeting cancer stem cells.

Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this project we direct our attention to the practices involved in translational medical research and especially how various stakeholders implement their work. We look at decision-making among key stakeholders by performing interviews with preclinical researchers, early phase trial investigators and independent expert researchers in two translational medical arenas: cell therapy for Parkinson’s disease and drugs targeting cancer stem cells.

By investigating how various stakeholders describe, reason about, approach, and resolve questions about ethics and study validity, guidance can be established on a design and review principles for trial launch.

This project is financed by FORTE and it began i January 2013.



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