GCP Clinical Trials: Understand the Matter of GCP Standards

Abstract

“Good Clinical Practise” (GCP) is a worldwide ethical and scientific quality standard for clinical trial design, conduct, performance, monitoring, auditing, recording, analysis, and reporting. It also helps to protect the privacy, dignity, and rights of test participants. Understanding the history of the ICH-GCP principles is important since it offers reason for their use. In this article, we will look at the historical backdrop and events that led to the formation of these proposals. Today, the fundamental purpose of implementing ICH-GCP principles in clinical trials is to protect and preserve human rights.

DEFINITION

“Good Clinical Practise” (GCP) is a worldwide ethical and scientific quality standard for clinical trial design, conduct, performance, monitoring, auditing, recording, analysis, and reporting. GCP clinical trials provide confidence that the rights, integrity, and confidentiality of trial participants are preserved and maintained, and that the data and reported conclusions are trustworthy and accurate [1]. Despite the fact that it was finished in 1996 and put into effect in 1997, no law was in place to implement it at the time. The European Union (EU) Directive on Good Clinical Practise and the Medicines for Human Use (Clinical Studies) Regulations 2004 changed the global perspective, and GCP compliance is now mandatory in the UK and Europe for all studies including the inspection of medicinal products [2].

HISTORICAL CONTEXT

Understanding the history of the ICH-GCP standards is important because it demonstrates the motives and need for doing so ((Table 1)). The Hippocratic Oath (460 BC) demonstrates that the concept of a “good doctor” has been around since antiquity. The Food and Drugs Act of 1906 established drug regulation in the United States. This was caused by harmful and lethal pharmaceuticals that could be acquired over-the-counter like any other consumer commodity. Grandma’s Secret, Kopp’s Baby’s Friend, Dr. King’s Consumption Cure, and Dr. Bull’s Cough Syrup are just a few instances of items containing large amounts of morphine as well as morphine and chloroform [3]. In 1938, the Food and Drug Administration (FDA) approved the Federal Food, Drug, and Cosmetic Act, which for the first time required manufacturers to test their goods for safety before releasing them to the public [3].

German physicians who performed unethical and terrible experiments in Nazi concentration camps during WWII were eventually convicted and punished before the Nuremberg Military Tribunal, which resulted in the Nuremberg Code being created in 1947. This regulation specifies the requirement for a scientific basis for human subjects research, as well as participant protection and free consent [4,5]. Following the tragedies of WWII, the United Nations also ratified and proclaimed the Universal Declaration of Human Rights (December 10th, 1948), which reinforced the human aspect in medical research.

In 1964, the World Medical Association issued the Helsinki Declaration, which served as the basis for the ethical principles that support the present ICH GCP clinical trials guidelines. The introduction of this proclamation makes it clear that the protection of human rights is its primary focus [6]:

The World Medical Association produced the statement of Helsinki, a statement of ethical norms, to serve as guidance for physicians and other participants in human-centered medical research. The role of the physician is to promote and defend the public’s health. The doctor’s expertise and conscience are dedicated to completing this duty.

In 1962, the world was astonished by severe limb malformations in foetuses linked to maternal thalidomide use. In fact, 10,000 infants were born in over 20 countries before this pharmaceutical interaction was discovered. In response, the Kefauver-Harris Amendments were passed, which required the FDA to evaluate all new drugs for safety and efficacy [3].

The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research’s Belmont Report, issued in April 1979, was another key turning point in the establishment of the ICH-GCP standards [7]. The report’s guiding concepts are as follows:

Respect for Individuals: This principle appreciates each individual’s intrinsic worth and independence. It requires the informed consent of research participants (or their officially chosen representatives).

Beneficence: This concept holds that researchers must maximise the good consequences of their work while reducing the bad ones. Risks associated with research must be reasonable in light of the expected gains.

According to this concept, study subjects must be treated properly and be chosen and recruited in an equal way.
The World Health Organisation (WHO) and the Council for International Organisations of Medical Sciences (CIOMS) published ‘International Guidelines for Biomedical Research Involving Human Subjects’ in 1982. This guidance was created to help developing countries apply the Nuremberg Code and the Helsinki Declaration [3]. Several institutions and committees throughout the globe issued papers and recommendations on the same subject. All of these recommendations were determined to be combined into a single, globally applicable standard.

The ICH Recommendations: The International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued Topic E6 GCP Guidelines in an effort to overcome national disparities in GCP. On July 17, 1996, this suggestion was adopted, and it became effective for clinical investigations on January 17, 1997. Participants in the preparation of these suggestions included officials and representatives from the EU, Japan, the United States, Australia, Canada, the Nordic countries, and WHO [8].

ICH-GCP

The ICH-GCP is a unified standard that protects human subjects’ rights, safety, and welfare, limits the amount of time people are exposed to investigational items, improves data quality, expedites the marketing of novel pharmaceuticals, and reduces costs for sponsors and the general public. By adhering to this criteria, the public may be guaranteed that the rights, safety, and welfare of trial participants are protected in accordance with the precepts of the Declaration of Helsinki, and that clinical trial data is credible [8]. Table 2 offers a historical context for the goals and importance of GCP.

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