Global clinical trials: Calling the hype to task

The results of two recent studies suggest that the dispersion of clinical trials is not nearly as global as commonly believed. The promise of conducting clinical trials in emerging regions, gaining access to well-trained investigators and a large volume of treatment-naïve patients, and the realization of economic and efficiency advantages has been hyped. Clinical trials regulated by the FDA remain predominantly in mature global markets. The Tufts Center for the Study of Drug Development (Tufts CSDD) recently evaluated FDA data on Form 1572 filings.

Advisory boards amplify patients’ voices

A strong and growing desire to solicit feedback directly from patients, experienced participants and their support network is prompting many sponsors and CROs to assess, plan and implement patient advisory panels. This feedback is providing valuable new insight into protocol feasibility, ways to improve study positioning and patient recruitment and retention communications, and clinical trial medicine kits.

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