By Richard Chin, Menghis Bairu
This e-book will discover the good possibilities and demanding situations which exist in undertaking medical trials in constructing nations. by means of exploring some of the rules particular to the main gamers and offering perception into the logistical demanding situations together with language obstacles, this booklet presents a operating instrument for scientific researchers and directors to navigate the intricacies of medical trials in constructing international locations. vital issues resembling moral concerns can be dealt with very rigorously to focus on the numerous adjustments of accomplishing this paintings in a number of jurisdictions. total, it's going to current a transparent and entire consultant to the ins-and-outs of medical trials in a number of international locations to help in layout, improvement, and effectiveness of those trials.
- Contributors comprise high-profile, revered figures who've prepared the ground for medical trials in constructing countries
- Provides hands-on instruments for regulatory and criminal necessities and qualification, layout, administration, and reporting
- Case reports define successes, mess ups, classes realized and customers for destiny collaboration
- Includes country-specific guidance for the main applied countries
- Foreword through David Feigel, former Head of CDRH at FDA
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Additional info for Global clinical trials : effective implementation and management
Extrinsic differences include environmental differences, such as climate and weather; cultural differences, such as languages and diet; medical treatment differences, such as treatment patterns and diagnosis; and population differences, such as prevalence of smoking. Intrinsic factors include genetic factors, such as polymorphisms in drug metabolism and genetic diseases; and physiological differences, such as size and cardiovascular function. While E5 classifies diseases as an intrinsic factor, in many cases it can be an extrinsic factor, such as prevalence of tuberculosis in the general population.
Of published clinical trials conducted in China in 2004, 90 percent proceeded without a prior ethical review of protocols. Eighteen percent satisfied the requirements for obtaining subjects’ informed consent . • In 1991, the US Department of Health and Human Services issued a set of guidelines (“Federal Policy for the Protection of Human Subjects”), referred to as the “Common Rule”, incorporating standards for IRB membership, function, operations, review, and record-keeping in trials funded or regulated by federal agencies and the FDA.
Reproductive toxicity studies assess the effects of the compound on fertility, reproduction, and fetal toxicity; they involve repeated administration of the compound to the animals before, during, and after a gestational period. These studies must be completed before submitting a New Drug Application (NDA) to the FDA. All the studies must be conducted under the ICH good laboratory practice (GLP) guidelines  (the toxicology equivalent of GCPs). 4. Regulatory Agencies Involved in the Regulation of Drugs and Devices The FDA is an agency within the Department of Health and Human Services and consists of centers and offices that regulate various aspects of foods, drugs, and cosmetics.