Analysis of Good Clinical Practice (GCP) Guidelines and Their Impact

This report provides an overview of Good Clinical Practice (GCP) guidelines, emphasizing their importance in ensuring the ethical and scientific validity of clinical trials. It traces the history and evolution of GCP from the Hippocratic Oath to modern guidelines from organizations like WHO, USFDA, and ICH. The report specifically addresses the significance of GCP in India, highlighting the challenges and regulatory changes impacting clinical research in the country. It discusses the initial promise of the Indian GCP version introduced in 2001 and its comparison with ICH-GCP, noting the preference for ICH-GCP due to the complexities of the Indian version. The conclusion underscores the need for simplified and more practical Indian GCP guidelines to enhance their adoption and effectiveness in promoting quality clinical research.

Running head: GOOD CLINICAL PRACTICE
GOOD CLINICAL PRACTICE
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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 field1. 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 society2. 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 data3. 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.
1 World Health Organization. "Handbook for good clinical research practice (GCP): guidance for
implementation." (2005).
2 Mahan, Vicki L. "Clinical trial phases." International Journal of Clinical Medicine 5, no. 21 (2014): 1374.
3 Verma, K. "Base of a research: good clinical practice in clinical trials." J Clin Trials 3, no. 1 (2013): 100-28.

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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 trials4. 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, the sponsors started
focusing more on saving costs and on their potential for increased patient recruitment5.
Secondly, the investigators started to get more interested in the commercial benefit out of the
biomedical trials6. 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
4 ABDU, J., UL KAL, LAM TE, and CAL UN. "M. Phar."
5 Mallath MK, Chawla T. Investigators viewpoint of clinical trials in India: Past, present, and future. Perspect
Clin Res. 2017;8:31–6.
6 Thatte UM, Marathe PA. Ethics Committees in India: Past, present, and future. Perspect Clin Res. 2017;8:22–
30

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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 India7.
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 more8.
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
7 Bajpai, Nidhi. "Clinical Data Management Process Standardization for Vaccine Trials in an Indian
Pharmaceutical Company, Under Indian Regulations." (2015).
8 Bhatt A. Are registered ethics committees empowered to ensure human research protection? Perspect Clin Res.
2016;7:149–151. [PMC free article] [PubMed]

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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.

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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;7:149–151. [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;8:31–6.
Thatte UM, Marathe PA. Ethics Committees in India: Past, present, and future. Perspect Clin
Res. 2017;8:22–30
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).