GCP In The Global Perspective Samples †MyAssignmenthelp.com

Question: Discuss about the GCP In The Global Perspective. Answer: Introduction The simple definition of Good clinical practice (GCP) would be the guidelines covering areas such as design, research, conduct, analysis, audit, documentation, termination and, reporting of various studies relating to the biomedical field[1]. The major concept of the GCP guidelines is that when researching on human beings, the well being of the subject under study needs to be of more concern than the interests of science or society[2]. GCP aims at ensuring both the scientific as well as the ethical validity of studies and that the research concerning the various clinical properties of medical substances is efficiently documented. GCP in the global perspective The history of the GCP can be traced back to The Hippocratic Oath which is one of the most ancient traditions in the history of medical sciences. The primary code of this oath is to make sure that no harm is caused to the patient, however, in case of modern medical research, a more intricate set of guidelines for the practitioner in terms of his/her ethical and scientific responsibilities in various biomedical research. The two major principles of GCP is to protect human rights and to generate authentic biomedical data[3]. Evolution of these guidelines has taken place with consideration of the guidelines of certain major organizations like WHO, USFDA, European GCP Guidelines, ICH and also the Indian Council of Medical Research issued Ethical Guidelines for Biomedical Research on Human Subjects. These Ethical Guidelines for Biomedical Research on Human Subjects are required to be followed in India when carrying out any sort of biomedical research and at every step of such research. Significance of GCP in India India became a budding field of clinical trials from 2005, after the amendment of Schedule Y. The growth had begun, yet clinical practices required formation of roots in order to stabilize within the system. The fundamental roots of a clinical trial include the protection of well-being, safety, and rights of participants in a clinical trial. Another important aspect of the scope of clinical trials to spread is to improve the knowledge and sharpen the skills required in conducting ethical, safe, quality and scientific trials in clinical research. The primary stakeholders like the regulators, sponsors, ethics community (ECs) and the investigators have the responsibility to nurture the field of clinical trials by establishing proper guidelines to fulfill the two major aspects of clinical trials[4]. However, the past five years had Indian media highlighting the deviation in ethics and safety issues in clinical trials. There were numerous factors that led to such circumstances; firstly, t he sponsors started focusing more on saving costs and on their potential for increased patient recruitment[5]. Secondly, the investigators started to get more interested in the commercial benefit out of the biomedical trials[6]. Thirdly, the ethics community started functioning inadequately and finally, an oversight for effective regulation was lacking. The regulatory authority, in response to the directives of the Supreme Court in 2013, framed new rules and regulations for numerous important process in biomedical trials including registrations of the ethical communities, compensation and the audio-visual recordings of the consent from individuals. This step resulted in a number of circumstances. Firstly, the workload of the ethics communities increased by manifolds, secondly, the various institutions and their investigators lost interest in conducting clinical trials as the burden of the regulations increased and that outweighed the benefits of conducting biomedical trials. Thirdly , the number of new clinical trials drastically reduced owing to the fact that India was no more an attractive and cost-effective destination for clinical research for the global sponsors. This, in turn, caused the regulators to amend the stringent regulations in 2015, thereby improving the prospects of growth in clinical research in the present day in India[7]. Scope of GCP in India The GCP guideline that was introduced in India in 2001 did not show much potential further. The Indian GCP version was initially designed in a similar fashion as other guidelines, like Schedule Y, ICMR, and ICH-GCP guidelines, which however was not accepted in the industry. India still follows the ICH-GCP as the gold standard is easier to comply with. The need for an Indian version of GCP was required initially in order to have a uniform clinical trial quality across the nation thereby to be able to produce data for registering new drugs before the Indian population can use them. However, this does not seem appealing as the Indian GCP version is very difficult to practice. GCP guidelines have been formulated from ICH-GCP; however, there are numerous differences between the two. Indian GCP leads the research towards very difficult methodology, therefore, becoming a challenge for the ECs, Sponsors, and investigators. There are certain key differences between the two guidelines in terms of qualification of investigators, compliance with the various SOPs, complexities in the consent process, complicated documentation of drug labels and timelines and many more[8]. Conclusion Therefore, it can be concluded that, the reason behind creating Indian guidelines of GCP was anticipation of good deeds, however, Indians still prefer to abide by the ICH-GCP guidelines and the Indian version will have a greater scope and significance once the complexity of the guidelines is reduced, practical implications are improved and compliance to the rules is made easier. References ABDU, J., UL KAL, LAM TE, and CAL UN. "M. Phar." Bajpai, Nidhi. "Clinical Data Management Process Standardization for Vaccine Trials in an Indian Pharmaceutical Company, Under Indian Regulations." (2015). Bhatt A. Are registered ethics committees empowered to ensure human research protection? Perspect Clin Res. 2016;7:149151. [PMC free article] [PubMed] Mahan, Vicki L. "Clinical trial phases." International Journal of Clinical Medicine 5, no. 21 (2014): 1374. Mallath MK, Chawla T. Investigators viewpoint of clinical trials in India: Past, present, and future. Perspect Clin Res. 2017;8:316. Thatte UM, Marathe PA. Ethics Committees in India: Past, present, and future. Perspect Clin Res. 2017;8:2230 Verma, K. "Base of a research: good clinical practice in clinical trials." J Clin Trials 3, no. 1 (2013): 100-28. World Health Organization. "Handbook for good clinical research practice (GCP): guidance for implementation." (2005).