Clinical trial - WikipediaPrinciples and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Individuals engaged in clinical research, including both students and scientific researchers as well as physicians and members of allied health professions. Ethical Principles in Clinical Research 3. Institutional Review Boards 5. International Regulation of Drugs and Biological Products 7.
Enter Id of the course to which this question should be moved. Manmeet Kaur Guide-Level Hi Akshay, Shiksha is an education portal and provides guidance regarding education and career sector only. If you have any concern then you may post any query regarding that. Wish you Luck! Clinical research is a specialized field that requires specific training to carry out various job functions. With the increasing number of clinical trials there is a projection of the requirement of trained manpower in big numbers.
The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of legumes in biblical times to the first randomized controlled of trial of streptomycin in , the history of clinical trial covers a wide variety of challenges - scientific, ethical and regulatory. The famous scurvy trial conducted by James Lind contained most elements of a controlled trial. This paved the way for the first randomized control trial of streptomycin in pulmonary tuberculosis carried out in by MRC of the UK. This landmark trial was a model of meticulousness in design and implementation, with systematic enrolment criteria and data collection compared with the ad hoc nature of other contemporary research.
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Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments such as novel vaccines , drugs , dietary choices , dietary supplements , and medical devices and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies , and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers , in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.