Abstract
The Clinical Trial Protoc ol is the foundation upon which the study design is built. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary goal of a trial is to generate new knowledge about a potential medicine so that regulatory authorities can determine whether the medicine is safe and effective and the primary purpose of clinical trial is to advance the knowledge of researchers and regulators so that new treatments and cures can be developed. A guide to an effective Clinical Trial Protocol in CGMP & CGCP as a tool for sustenance of Ethical Principles and Regulatory requirements in the Pharmaceutical and Research Industry is a contemporary perspective on how professionals in the medical, pharmaceutical and research industries can utilize available resources in developing their clinical trial protocol based on sound scientific and ethical doctrines or principles with the primary intention of protecting research subjects or participants while adding meaning to the necessity for the continuation of research practices in our society. Additionally, a well-articulated clinical trial protocol and subsequent amendment(s) in practice, as the case may be, will further enhance professionals’ understanding and limitation(s) with greater emphasis on risk management, continuation of the study and importantly when to stop if it is deemed necessary or if the risk/benefit ratio becomes high enough to compromise either the study participants and or compromise ethical principles as enunciated in the Declaration of Helsinki, the Belmont report and the GCP principles contained in the International Conference on Harmonization (ICH).
Highlights
The Clinical Trial Protocol is the foundation upon which the study design is built
According to the Pharmaceutical Research and Manufacturers of America (PhRMA) [1], the primary goal of a trial is to generate new knowledge about a potential medicine so that regulatory authorities can determine whether the medicine is safe and effective and the primary purpose of clinical trial is to advance the knowledge of researchers and regulators so that new treatments and cures can be developed
The protection of human subjects in line with the ethical principles as enumerated in the Belmont Report and in the Declaration of Helsinki, and that integrated into the good clinical practices as contained in the International Conference on harmonization (ICH) [2], and the conduct of clinical trials which must be based on scientifically sound study design can only be achieve by adhering to the approved clinical trial protocol
Summary
The Clinical Trial Protocol is the foundation upon which the study design is built. According to the Pharmaceutical Research and Manufacturers of America (PhRMA) [1], the primary goal of a trial is to generate new knowledge about a potential medicine so that regulatory authorities can determine whether the medicine is safe and effective and the primary purpose of clinical trial is to advance the knowledge of researchers and regulators so that new treatments and cures can be developed. The protocol is the basic tool of clinical trials and if well written and the study design is sound, the study will have the capacity to generate valid date that are acceptable to the scientific community including especially the Food and Drug Administration (FDA) and other regulated bodies as the case may be. In order to receive favorable response from the scientific and regulatory communities especially the FDA in terms of clinical research conducted within the USA, every protocol must attempt to satisfy and provide sound, scientific and ethical answers to regulatory requirements by the FDA through the Code of Federal Regulations among others.
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