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News From Around The Industry

CWWeekly Features

CTTI: Instituting Quality Measures Early in Trial Design Pays Off in the Long Run

At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency.

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Principal Investigator Eligibility – GCP Questions, FDA Answers

FDA regulations provide that sponsors select principal investigators (PIs) qualified by training and experience. The regulations do not, however, provide answers for every possible contingency sponsors face in PI selection or management.

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Trial Results & Briefs

EMA Draft ‘Strengthens’ Guidance on Safety Follow-Up for Advanced Therapies

The EMA published a draft revision to its guideline for clinical trials follow up of advanced therapy medicinal products, including gene therapies, cell therapies and tissue engineered products. The draft strengthens and clarifies the EMA’s 2008 guideline, and includes more details on designing post-authorization safety and efficacy follow-up studies.

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Phase III PROSPER Trial Shows positive results for XTANDI

Astellas Pharma and Pfizer announced results from the Phase III PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The Phase III randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with M0 CRPC.

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