Clinical Trial Management – an Overview

By Editor IJSMI

Clinical Trials word became a buzz word during this pandemic situation. It played a crucial role in developing vaccine to fight the pandemic.

Experts from different fields contribute to the development of vaccine which includes (not limited) clinical researchers, health care providers, pharmaceutical industry, data managers, biostatisticians, data scientist and clinical trial programmers. Data collection, management, analysis and reporting also play an important role in helping decision makers in approving and rejecting the vaccine.  

This book provides an overview of clinical trial management process including protocol development, subject recruitment, professionals and organizations involved in clinical trial, data collection, analysis and reporting. It also covers the models related to Clinical Data Interchange Standards Consortium (CDSIC) standards such as Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

This book is the second book in the clinical trials series written by the author. Readers are encouraged to refer to the author's book on Essentials of Biostatistics – An overview with the help of Software for biostatistics related contents.

This book is intended for Clinical Trial Managers and clinical research professionals.

Editor IJSMI

International Journal of Statistics and Medical Informatics

• Language: English
• Publisher: IJSMI
• Release date: Jan 2, 2021
• ISBN: 9781393155997

Editor IJSMI

Editor, International Journal of Statistics and Medical Informatics www.ijsmi.com/book.php [e-mail]

Book preview

Chapter-1: Introduction

Clinical trials are experiments conducted in a controlled setting in search of answers to the disease related problem or in general health related issues faced by human beings. 

Several stakeholders are involved in the process namely clinical researchers, pharmaceutical organizations, human participants, academic researchers, regulatory authorities and government authorities at the local and national level.

Though the clinical trials started long ago, International Conference on Harmonization’s (ICH) guidelines and standards had greater impact on how the clinical trials should be conducted, most importantly in an ethical manner while ensuring the safety of the clinical trial participants. ICH provides standards for designing, conducting, reporting and recording clinical trials which involve human participants.

Clinical trials are normally conducted in 4 phases apart from the preclinical phase where in the drug or interventions are formulated in the labs. Phase-I emphasizes on safety of the drugs with fewer human subjects (around 20), Phase-II emphasis on safety and efficacy with little more number of human participants than Phase I (around 100). Phase III clinical trials are conducted among large number of participants. It confirms the safety, efficacy and dosage of the drugs or interventions. After the Phase III clinical trials the intervention or drug will be sent for approval for mass distribution. Phase IV will involve post surveillance focusing on any adverse events.   

With the introduction of technological tools it is now possible to plan, design and conduct clinical trials in a systematic and cost effective manner. The vast amount information in the form clinical literature and Electronic Medical Records(EMR) helps the clinical research professionals to identify the root cause of the problem quickly and design their clinical trial strategies to overcome the issues faced by the human population. Data Science and Machine learning tools helps to analyze and create meaningful reports for the clinical decision makers.

References

https://ichgcp.net/

https://www.clinicaltrials.gov/

https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies

https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Ratitch, B., Goel, N., Mallinckrodt, C., Bell, J., Bartlett, J. W., Molenberghs, G., ... & O’Kelly, M. (2020). Defining efficacy estimands in clinical trials: examples illustrating ICH E9 (R1) Guidelines. Therapeutic innovation & regulatory science, 54(2), 370-384.

Liu, X., Rivera, S. C., Moher, D., Calvert, M. J., & Denniston, A. K. (2020). Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. bmj, 370.

Hill, A. B. (1952). The clinical trial. New England Journal of Medicine, 247(4), 113-119.

Schafer, A. (1982). The ethics of the randomized clinical trial. New England Journal of Medicine, 307(12), 719-724.

Mann, H. (2002). Research ethics committees and public dissemination of clinical trial results. The Lancet, 360(9330), 406-408.

Chapter 2 – Clinical trial protocol development

Protocol Development is the main important task in the clinical trial process. It is a blueprint of what we are planning to do in each stage of the clinical trial process. It ensures the smooth flow of processes, data integrity, reduces noncompliance and also ensures safety of the participants in the trial.

The following section provides the summary of the following components of a normal protocol mainly applicable for Randomized Control Trials as it was the widely used study type. Some of the components will be discussed in details separately.