Clinical Trial Protocol for Public Reference!!!

A clinical trial is an examination of one (or more than one) therapeutic product commenced
with a particular description when administered to a patient or number of patients. The
investigations evaluated are based on numerous factors such as; clinical, pharmacological,
pharmacodynamics (beneficial or harmful effects) and etc. The importance of clinical trials has
increased over time as the progression and the occurrence of new diseases. According to the
European Commission Directive 2001/20/EC; clinical trial is the way of development of new
medicines, further improvement in the existing medicines and facts based improvement of
treatments with medicines.

The clinical trial of a study starts with the development of a clinical trial protocol that
pronounces all the details of the clinical trial such as; how the clinical trial will be conducted,
its objectives, design, methodology, statistical analysis and etc.
The NIH, FDA recently released the rationalised clinical trial protocol template (can be
found at http://osp.od.nih.gov/sites/default/files/Protocol_Template_05Feb2016_508.pdf) to
enhance the efficiency of clinical trials possibly by saving the development time and money.
This newly released template developed by the joint efforts of the National Institute of Health
(NIH) and by the Food and Drug Administration (FDA). The clinical trial protocol has been
released for the Phase II and Phase III investigational new drug (IND) studies. The important
points that enhance the reliability of the clinical trial protocol template are presented in
Figure 1.
The main aim of releasing the protocol is to make it easier for the investigators while writing
a clinical trial protocol.
The protocol covers instructions, sample text (arranged in a controlled fashion) that covers
all the information that are essentially required for the trial to be properly reviewed.
The protocol aims the safety of the trial subjects involved and the integrity of results
collected during the clinical trial.
The template of a clinical trial follows the International Conference on Harmonisation
(ICH) E6 Good Clinical Practice: Consolidated Guidance.
On the same way, for medical devices, the guidelines have been according to International
Organization for Standardization (ISO) Clinical Investigation of Medical Devices for
Human Subjects- Good Clinical Practice (ISO 14155:2011).
According to Peter Marks (the director of the Centre for Biologics Evaluation and Research
(CBER) at FDA), there are approximately 85 percent of the investigators who have not
participated in more than one clinical trial in their whole career. Indeed, these investigators will
lack in their momentous experience of protocol development.
However, the release of the clinical trial protocol template will benefit these investigators
mostly by providing additional guidance during a clinical trial. Now, the FDA and NIH is
seeking public comments and advice after its release for further improvement of drafted
template.