Designing and Conducting Clinical Trials — An overview
Clinical trials can be defined as an experiment which is conducted in a controlled environment to test the efficacy drugs, procedures, methodology before bringing into the public domain. The clinical trial started in 2nd century BC by Daniel & King Nebuchadnezzar and first formal recorded therapeutic clinical trial started way back in 1537 AD by a Surgeon. It progressed over time in terms of clear guidelines for conducting trails, ensuring adherence to regulatory requirements, getting consent from the patients, ensuring safety of the patients, adopting ethical practices, close monitoring the trials, using advanced statistical tools to analyze and report the findings of the trial.
Advancement in technology such as cloud computing, big data analytics, machine learning algorithms, data base management and advanced statistical software helped to transform the different parts of clinical trials — the data collection, data storage, data monitoring, data management and data analysis.
This book provides an overview of clinical trials, different phases & types of clinical trial, randomization, blinding, allocation, ethical issues, protocol, data collection forms, data management, data analysis, different roles involved in conducting the clinical trial.
https://www.amazon.com/dp/B07RCB917 — E-book
https://www.amazon.com/dp/1096489082 — Paper back
ISBN — 978–1096489085
It is recommended to refer author’s book on Application of Statistical Tools in Biomedical Domain: An Overview with Help of Software (https://www.amazon.com/dp/1986988554) and Essentials of Bio-Statistics: An overview with the help of Software https://www.amazon.com/dp/B07GRBXX7D if you need to familiarize yourself with the basic statistical knowledge.
Editor
International Journal of Statistics and Medical Informatics
