Adaptive Trial Design: Could We Use This Approach to Improve Clinical Trials in the Field of Global Health?
Open Access
- 1 December 2011
- journal article
- Published by American Society of Tropical Medicine and Hygiene in The American Journal of Tropical Medicine and Hygiene
- Vol. 85 (6), 967-970
- https://doi.org/10.4269/ajtmh.2011.11-0151
Abstract
We need more clinical trials in the world's poorest regions to evaluate new drugs and vaccines, and also to find better ways to manage health issues. Clinical trials are expensive, time consuming, and cumbersome. However, in wealthier regions these limiting factors are being addressed to make trials less administrative and improve the designs. A good example is adaptive trial design. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to reduce product development times and costs. If this approach makes trials easier and less expensive surely we should be implementing this approach in the field of tropical medicine and international health? As yet this has rarely been proposed and there are few examples. There is a need for raising the awareness of these design approaches because they could be used to make dramatic improvements to clinical research in developing countries.This publication has 24 references indexed in Scilit:
- Adaptive Clinical Trial Design: Has Its Time Come?JNCI Journal of the National Cancer Institute, 2010
- Clinical Research in Resource-Limited Settings: Enhancing Research Capacity and Working Together to Make Trials Less ComplicatedPLoS Neglected Tropical Diseases, 2010
- Adaptive Designs for Randomized Trials in Public HealthAnnual Review of Public Health, 2009
- Adaptive trial design: A general methodology for censored time to event dataContemporary Clinical Trials, 2009
- La información en tiempo real. Una herramienta necesaria en vigilancia epidemiologicaGaceta Sanitaria, 2008
- Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?PLoS Medicine, 2008
- Building Clinical Trials Capacity for Tuberculosis Drugs in High-Burden CountriesPLoS Medicine, 2007
- A Regulatory View on Adaptive/Flexible Clinical Trial DesignBiometrical Journal, 2006
- Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working GroupJournal of Biopharmaceutical Statistics, 2006
- A Unified Theory of Two-Stage Adaptive DesignsJournal of the American Statistical Association, 2002