Protocol Design

Managing a successful Phase III global oncology trial presents one of the most complex challenges drug companies face within the development cycle.

Incorporating original study design accelerates better development decisions.

An insightful review of Remedica's 2005 Clinical Trials: A Practical Guide to Design, Analysis, and Reporting

The protocol should describe the minimization process and processes to minimize systematic bias, as this can influence practical aspects of the study.

FDA plans to rewrite rules governing electronic records while offering new policies to encourage risk-based regulatory approaches to application review and inspections.

Pharmaceutical companies and contract research organizations are setting up an increasing number of clinical trials in Central and Eastern Europe. The region offers attractive opportunities for sponsors to accelerate subject recruitment and to carry out clinical trials according to harmonized international standards and regulations. Recent concerns about data quality and cost-efficiency at CEE investigational sites, however, have led to regular evaluation of sites' clinical research performance and capacity. Now it is essential to introduce benchmarking and performance measurement to the conduct of clinical trials to identify best practices and to continually improve clinical research.

Pediatrics and geriatrics are the latest hot topics in the EU, so the CPMP is at least starting to help companies develop new clinical trials for children.

The agency is shifting regulation of biotech therapies to its drug center, a streamlining initiative to be implemented by a new FDA commissioner.

Both personal health considerations and altruism helped keep this subject in a long-term study.

A review of Edyta J. Frackiewicz, Thomas M. Shiovitz, and Stanford S. Jhee's clinical trial book.

A new guideline details basic requirements for submitting a successful application for a proposed orphan drug in the European Union.

José Biller and Julien Bogousslavsky, Eds.

The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.

The EMEA updates its positions on placebos, Crohn?s disease trials, and postmarketing surveillance of drugs used by pregnant women.