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Investigation: Early Clinical Trials

Final report: PCM Report – Early clinical trials

Investigator: Luigi De Petris

Background

The PCM program requires a well-structured and affordable clinical trial constellation to translate preliminary discoveries into robust clinical wins for patients. The ‘one-size-fits-all’ approach that delivers minimal benefit does not fit into a PCM concept. Molecular stratification strategies aiming at matching the trial to the patient rather than finding the right patient for the trial are to be pursued. Clinical trials must increasingly be more cooperative (bridging the academia-industry intersect) and deliver benefit from a health, innovation, economic and societal perspective. In order for this to be achieved, the integration and alignment of multiple stakeholders across the health care system must be established at en early stage to ensure that innovation and ‘real’ benefit is rewarded.

Objectives

This investigation aims at outlining the current status of early clinical trials in Stockholm, focusing on investigator-initiated studies. The purpose is to provide an overview on what are the challenges and possibilities to conduct trials with innovative designs and in depth translational components.