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 of drugs, procedures, methodology before bringing into the public domain. The clinical trials started in 2nd century BC by Daniel & King Nebuchadnezzar. Formal recorded therapeutic clinical trial was started way back in 1537 AD by a Surgeon. Current clinical trials include clear guidelines, adhering to regulatory requirements, getting consent from the patients, ensuring safety of the patients, adopting ethical practices, close monitoring of the trials and using advanced statistical tools to analyze and report the findings. 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 stages 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 and reporting of the clinical trial. 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. EditorInternational Journal of Statistics and Medical Informatics