Clinical Trial Basics
Scroll down for details.
Author: Johan PE Karlberg
Editors: Johan PE Karlberg and Marjorie A Speers
Although the publication is entitled Reviewing Clinical Trials: A Guide for the Ethics Committee, it was developed mindfully to be relevant and useful to all other categories of professionals entering the clinical trial research area. We highly recommend anyone, whether a novice in the clinical trials research area or experienced, wishing to learn more about the basic modern concepts of human research ethics and clinical trial research methodology to study this manual. The audience can equally be professionals acting as investigators, research nurses, research support staff, ethics committee administrators, contract and budget development administrative staff, monitors, project managers, biostatisticians, clinical data managers, regulators or inspectors.
We must stress that nothing in this manual overrules local laws, regulations and guidance. It was developed to provide an overall, theoretical background of clinical trials following the general principles spelt out in the Declaration of Helsinki and the ICH GCP E6 Guideline. The final chapter includes 48 ethics committee scenarios covering most ethical areas in human research. Many of those scenarios have been utilized in educational activities for ethics committee members and have proven exceptionally helpful in translating theory into practice, especially for novice clinical trial research professionals.
The book has been translated to Chinese, Spanish and Portuguese.
Pfizer, New York, USA supported the development of this book with an unconditional research grant.
A group of international human research protection experts mostly working in non-profit institutions or organizations reviewed and provided important comments on the contents and final draft.
Tips and suggestions
- ❶ Download the book.
- ❷ Ask you supervisor if the contents is appropriate.
- ❸ Try to organize a reading group.
- ❹ Identify a senior staff as a tutor.
- ❺ Read some pages of the book.
- ❻ Meet the group and discuss, etc.
- ❼ Repeat 5-6 until Chapters 1-3 have been completed.
- ❽ Watch a few video scenarios - see below.
- ❾ Meet the group and discuss want you have learnt.
- ❿ Repeat 8-9 until all videos has been reviewed.
Research Ethics Scenarios
In this site, you can find YouTube videos corresponding to 48 research ethics scenarios: Ethics Scenarios
Book Chapter 4. Scenarios of Ethics Committee Review. The last chapter of the book includes several specifically themed sets of EC scenarios that cover a wide range of topics in relation to ethics in human research, from expedited or full EC review to clinical trials registry.
Most of the scenarios have been utilized in educational activities for EC members and have proven helpful in translating theory to practice, especially for novice EC members.
Exam - test your knowledge
The book formed a module in a Master’s Degree program – Master of Medical Sciences in Clinical Trial Research Methodology.
Test your knowledge now by an online Short Exam: Short Exam
There will come a full online exam based on the book. All CTM Members will be informed by email when the exam is available online.
Commentaries by the international advisors
Mark Barnes - USA “This guide provides to the 'learned layperson' a wealth of information about clinical trials – what they are and how they are designed and conducted – to allow such laypersons to become confident members of research ethics committees and IRBs. Such a publication, learned and yet accessible, is, in my experience, unprecedented.
”Ames Dhai - South Africa “The Manual will complement other readings in the field.”
David G Forster - USA “It is a good manual in that it is widely applicable to IRB review and is not wed to one country's regulatory requirements.”
Edwin C Hui - Hong Kong “This guide is comprehensive and condense enough to be read in an afternoon.”
Juntra Karbwang - Switzerland “ I believe that this Manual is a better choice over other similar books, since the EC members should have at least an overview of product R&D and different study designs to do a better risk assessment and better identify the ethics issues within different study designs.”
Boleslav L Lichterman - Russia “The book is concise, clearly written and has many visual aids - tables and figures - and a chapter on typical EC scenarios. These are evident advantages over other numerous publications on research ethics and GCP.”
Ulf Malmqvist - Sweden “This manual is a good introduction to practical ethics in clinical trials and is a complement to books covering ethics or good clinical practice.”
Carlo Petrini - Italy “I think that the Manual is clear, complete and provides a synthetic overview.”
Mildred Z Solomon - USA “This Ethics Guide is a comprehensive introduction to the conduct of clinical trials, and will be very useful to investigators new to clinical research methods and the complicated web of ethical and regulatory issues that guide that research.”
Marc B Wilenzick - USA “This ethics manual should be an invaluable resource for many ethics committees, across both high resource and low resource regions”
John R Williams - Canada “This Guide fills a niche between short statements and book-length treatments of research ethics.”