Clinical trials are an important part of medical research and these investigations help determine how new treatments will work in human patients and also in collecting valuable data about the effects of new drugs, medical approaches, and procedures.
This ebook gives an overview of the clinical trials process, the ethical requirements, latest trends, and the importance of a clinical trials database. Our goal for this ebook is to provide young clinical researchers with comprehensive information regarding the various processes involved. We’ve included specific pointers which researchers can adopt while conducting clinical trials and also while publishing their trials in journals.
Whether you’re a researcher, student, or both here’s what you can expect from “Clinical Trials: The Fundamentals”.
Conducting Clinical Trials
Clinical trials are carried out with stringent research standards that help ensure patients’ interests are protected whilst also establishing reliable study results. Authors and researchers can learn the importance of conducting such trials in adherence to these guidelines. Researchers will get an insight into the various phases of clinical trial studies. In the opening part of this ebook, we look at:
- The basics of clinical trials
- Learn about trial protocol
- Learn about the various types of clinical studies: Interventional and Observational and the various phases involved
Clinical Trials Process
Registration is usually also mandatory for journal publication. In this section of the e-book, you can learn more about:
- How to go about preparing a clinical trial
- Various checklists required for journal publication
- Informed consent
- Institutional review board
- Learn how to register and publish a clinical trial
Ethical Requirements
Monitoring clinical trials is essential to ensure that clinical studies maintain scientific integrity and do not violate ethical standards. This is done both at the institutional level as well as regulated by the governments. In order to ensure that the clinical research meets both a scientific standard and an ethical standard, the World Health Organization (WHO) suggests a “recommended format for a research protocol.” In this section, we learn about:
- Declaration of Helsinki
- ICH Good Clinical Practice
- Codes of Ethics
OpenTrials: Open Database for Clinical Trials
OpenTrials is an open database for clinical trial research that has an aim to increase access to trials data and also improve transparency in the various clinical trial processes. This database is developed by Open Knowledge International and it is an open access, online database of materials from clinical trials worldwide. In this section, we learn about how OpenTrials works and also gain insights into:
- Funding and data sources
- Challenges involved in OpenTrials
This free e-book is full of comprehensive insights that will help researchers learn about the clinical trial development process and the ethical requirements involved in order to conduct and publish clinical research.
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