Applied Clinical Trials, Sep 1, 2003 - Applied Clinical Trials

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Applied Clinical Trials, Sep 1, 2003

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From the Editor

Clinical Trials and the Multicultural Society

By Toby Jane Hindin, EdD

Considerations for diverse cultural and societal norms

View from Washington

Research and Access Issues Challenge Policymakers

By Jill Weschler

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

View from Brussels

EU to Put the IT into Clinical Trials

By Peter O'Donnell

As information technology becomes more important to clinical trials, the EU is discussing how IT should be included in clinical trials legislation.

Feature Article

Multinational Clinical Trials: Breaking Language and Cultural Barriers

By Mary Stober

It is increasingly important for clinical trial personnel to break through the obstacles that language and culture present when conducting trials away from their home countries.

Bridging Strategies May Help Put Western Drugs on the Japanese Market

By Edyta J. Frackiewicz , Stanford S. Jhee

Restrictive regulations and cultural differences make regulatory approval in Japan elusive, but adopting new strategies may make that lucrative pharmaceutical market more accessible to non-Japanese companies.

Pediatric Subjects and Their Parents

By John P. Niles

Pediatric trials got a good report card from a survey that explored the motivators and experiences of young subjects and their parents.

Practical and Ethical Issues in Pediatric Clinical Trials

By Ronald Kurz , Dennis Gill

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

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