Applied Clinical Trials-11-01-2013

Policies to widen access to patient level data from clinical trials are gaining traction, despite strong opposition from research sponsors that such initiatives will undermine patient privacy and incentives for new drug development.

Planning for ethnic sensitivity from a scientific and regulatory perspective.

IMS Health

Pharmacometrics optimizes the use of Phase II data to support Phase III success.

The European Forum for Good Clinical Practice has a vital role to play in bringing together all stakeholders to work out how to discharge their responsibilities in the framework of the clinical trial protocol for the protection of each consenting participant

Compromise is going to play a key role as the clinical trial rules update debate rages on.

Bring Your Own Device (BYOD) makes sense economically and socially and is the future of clinical trials.

Industry news focusing on the people and organizations who work in the clinical trials profession.

Adaptive trial designs have the potential to transform success rates, but require new operating strategies and practices.

Regulatory: Successful Phase III Trial Monitoring Trial Design: Multi-regional Trials Data Evaluation Also in this issue: Compromise in Europe's Rule Debate True Potential of Adaptive Trial Designs Bring Your Own Device