Become familiar with documents that are prepared
before, after and during clinical trials
Understand the importance of clinical trials in
the health industry and why thalidomide made them so important
Understand the role of the clinical investigator
Workshop 3
Overview of clinical trials and clinical trial documentation;
protocol, IND, investigator brochure, CRF
A clinical trial needs a site, a blueprint (a protocol), a
description of how data will be analyzed when the trial is complete (a
statistical analysis plan), study subjects who either have the disease
of interest (phase 2, phase 3 or phase 4 trials, and can be phase 1
trials) or do not have any disease (phase 1 trials). Read an article on clinical trials published in MJoTA.
Two great web-sites to get you started, one is the National Cancer Institute,
which carefully explains the differences between clinical trials, and
clinical trial phases, and walks patients through options for enrolling
in clinical trials themselves. The other website is the main website
for the United States, http://www.clinicaltrials.gov,
which is supposed to list all clinical trials that will results in a
drug approved (or not) by the US Food and Drug Administration.
Clinical study reports are written to compile data from clinical
trials. The FDA needs to know about every patient who took any amount
of drug, every patient who enrolled in the trial. The ICH E3 was
compiled by a committee as a guideline of how to prepare a clinical
study report. It was published in 1996 and is still the reference
guideline. Some drug companies use this guideline as a template. Download from http://www.mjota.org/images/ICH_E3.pdf
The essay by Dr Stephen de Looze was written after he served on the
ICH3 committee. He is a very senior medical writing director at
Sanofi-Aventis in Germany. He is British, went to Germany to do a PhD
in insect biology. He lives in Frankfurt with his family,
Read through the first 5 chapters of Fossati and Foote, at least to become familiar with what is in the textbook. They explain how to write the regulatory documents. If you want to become a regulatory writer, you need to understand this textbook. Chapters in this book are source documents for topics to come. It is the only comprehensive textbook written by medical writer managers about clinical documents.
Summarize the trial process in
a list. List all the documents needed to start a clinical trial.
Write a protocol for a clinical trial of a malaria drug that has been developed from the neem tree. Make sure you define the phase of trial, how it will be conducted, the demographics, safety and efficacy. Make sure you have included the informed consent document. Where will you hold the clinical trial? How do you know the area you have chosen has the facilities to run the trial? What resources are needed to run the trial?
MJoTA has been published since 2006 by Emerald Pademelon Press LLC. PO Box 381 Haddonfield, NJ 08033, USA. MJoTA.org and drsusanna.org hosts MJoTA, and the Medical Writing Institute, which is a New Jersey nonprofit corporation. All inquiries for the Medical Writing Institute or Emerald Pademelon Press LLC: 01-609-792-1571; publisher@mjota.org. Contact the publisher directly through Facebook click here