What are good clinical practices and how did it come into being?
Clinical practices are an important aspect of clinical haphazard that influences the entire events of the study, safety of the participants and the researchers conducting the clinical study or trials of any organization. Good clinical practices throws emphasis upon the international ethical and quality standard regarding the study design, conduct, performance, analysis and accurate reporting of the clinical studies or trials with adequate source documentation [1]. GCP includes the guidelines that a researcher must keep in mind to ensure safe and ethical research; these guidelines were first introduced by International Council for Harmonization in June 1996 in an effort to overcome the consequences of unethical clinical trials confiscated by health practitioners that eventually resulted in fatalistic effects along with the abuse of human rights of vulnerable population [2]. The historical codes, research incidents such as Nazi experiments, Tuskegee Syphilis experiments, Jewish chronic disease study etc. gave birth to these codes involving standard ethics and quality for clinical trials. The ICH GCP constitutes of 13 fundamental principle guidelines categorized to ensure the safety and rights, integrity, confidentiality of the participants is protected as well as the data produced via the study or trial is of scientific quality with accuracy [3].
Why is GCP important and who needs to follow the guidelines:
Good clinical practices were produced in order to ensure the rights and safety of the participants, quality and accuracy of the data, and quality of the health associated products. GCP assists the clinical studies in many aspects, it increased ethical awareness for the involved participants, improved trial methods; GCP also helps in better understanding of the trial concept, it also involves the public as well as political concern over the safety aspects of the trial; GCP is also important for mutual recognition and analysis of the obtained data. GCP has also helped to overcome the frauds and accidents that were encountered by the participants during the clinical trials [4]. All the guidelines listed in ICH GCP are important in every aspect and when followed completely and accurately, the study bestows a good body and impression to the clinical study report within the ethical boundaries.
Clinical trials are usually done to check whether new vaccines, therapies or diagnostic procedures or any new health associated product to be launched has significant treatment effects as well understanding the side effects of the associated procedure. Regardless of whether a clinical test may be a multi-center, large study in patients or clinical pharmacological study in healthy subjects, the GCP standards must be followed accordingly by the sponsoring company of the healthcare product, the investigators, the ethics committees and any clinical research organizations [5].
A summary of the 13 fundamental ICH GCP guidelines:
The 13 principles of ICH GCP highlight different concerns regarding a clinical study or trial i.e. ethical principles, risk vs. benefit ratio, rights of the subjects, adequate supporting data, study described in detail, International Review Board or Independent Ethics Committee (IRB/IEC) oversight, medical care by investigator, qualified personnel, informed consent, record keeping, confidentiality, GMP implementation to the product and quality assurance and monitoring. All these facets are listed in detailed fashion and are self-explanatory; when summarized they simply mean:
Any clinical study or trial that is to be conducted must follow ethical principles, the study should sound scientific evidence and be reported in a clear detailed protocol. The benefits of the conducting trial must exceed the risks attained, ensuring the rights, well-being and safety of the participants involved in the study via obtaining an informed consent of the participants as well as maintaining confidentiality of the participants history. The participants must be ethnically diverse and taken care of by an appropriate qualified and experienced practitioner. All the data and the records obtained must be easily accessible and retrievable by appropriate individuals for accurate reporting, verification and interpretation. The product that is under investigation must be manufactured according to the Good Manufacturing Practice (GMP) approved protocol [2].
What are clinical documentation practices and its purpose?
As discussed earlier, ICH GCP guidelines have sorted all the necessary requirements of conducting a clinical trial involving a human subject. One of the critical element of ICH GCP guidelines was the accurate reporting of the clinical trials with adequate source documentation that could be accessed and retrieved by appropriate individuals for assessments and interpretations, all of this is only possible when the documentation initiatives are complete and accurate with well-defined detailed protocols [6]. Clinical documentation practices (GDPs) are the guidelines that must be followed for the record maintaining purposes of a clinical trial, to make sure that any form of raw data entries are recorded in a legible, reproducible and traceable manner, that could be recognized and easily accessible and understood by the appropriate individuals [7]. It has been reported that inadequate case histories has formed second ranked issue in US-FDA inspections of clinical trials [6]; keeping in mind the importance of good documentations, these documentations are the only key to assume that a trial has happened, moreover the results of the investigated subject or product purely depends upon the documentations provided to independent observers for further investigations. The accuracy of the documentation according to GDPs is also important as the data forms a firm foundation to be translated into a clinical study report. Regardless of obtaining accurate clinical trial records, GDPs are also important to protect the participants’ rights, safety and well-being [7].
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References:
[1] Guideline, I. H. T. (2001). Guideline for good clinical practice. J Postgrad Med, 47(3), 199-203.
[2] Committee for Proprietary Medicinal Products (CPMP). (1996). Note for Guidance on Good Clinical Practice (CPM/ICH/135/95). London: EMEA.
[3] Englev, E., & Petersen, K. P. (2003). ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives. Ugeskrift for laeger, 165(16), 1659-1662.
[4] Vijayananthan, A., & Nawawi, O. (2008). The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomedical imaging and intervention journal, 4(1).
[5] Buckley, B., Blanks, R., White, K. J., & White-Salters, T. (2014). Overview of the GxPs for the Regulatory Professional. FDA Regulatory Affairs, 235.
[6] World Health Organization. (2005). Handbook for good clinical research practice (GCP): guidance for implementation.
[7] Bargaje, C. (2011). Good documentation practice in clinical research. Perspectives in clinical research, 2(2), 59.
