Good clinical practice

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


Overview

Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonization]] (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

ICH GCP overview

"GCP" is an acronym that stands for "Good Clinical Practices". It is relevant to the clinical research industry as they are the international guidelines to follow that allows data to be portable from country to country.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) formed in 1990 and formally consists of regulatory authorities and industry representatives from the European Union (The European Medicines Agency (EMEA) and European Federation of Pharmaceutical Industries and Associations (EFPIA)), Japan (Ministry of Health, Labour and Welfare, Japan (MHLW) and Japan Pharmaceutical Manufacturers Association (JPMA)) and the United States (US Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America (PhRMA) ). There are also "observing" countries and agencies such as Canada (Health Canada), World Health Organization (WHO) and others. The purpose of the organization is to "make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines". By achieving harmonization, data from research gathered under ICH guidelines would be portable from country to country, thus saving time and resources in the development of medical therapeutics. These countries, although having additional laws surrounding medicinal product development, will have their basic laws in compliance with ICH and their guidelines.

ICH Topics are divided into four major categories for which they categorize their harmonization activity: Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). The relevant publication to this article is E6 entitled "Good Clinical Practice : Consolidated Guideline". The ICH summarizes this document as describing "the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs." The document was originally drafted in 1996 and later codified in Japan (PAB Notification No.430, MHLW Ordinance No.28), EU (CPMP/768/97) and USA (Federal Register, Vol. 62, No. 90, May 9, 1997, pages 25691-25709E7)in 1997.

Knowledge of Good Clinical Practices (or "GCPs") are considered basic training in the clinical research industry for any research professional. The Academy of Pharmaceutical Physicians and Investigators offers certification to physician investigators (Certified Physician Investigator or the "CPI" credentials) to those that meet certain experience criteria and can pass an board's examination. Additionally, the Association of Clinical Research Professionals will certify non-physician research professionals based on GCP knowledge as well. As industry sponsors typically want to use their data for filing in multiple countries, it would be difficult for an investigator to obtain a clinical trial without demonstrated training or certification of the GCPs. Additionally, Institutional Review Boards (IRBs) recognize the importance of GCP adherance to human subject protection and will request certification or other demonstration of training.

The GCP document identifies 8 sections

Section 1

Glossary The glossary, as the term implies, provides standard definitions for use in the research dialogue. By working off of a standard set of definitions and acronyms, the clinical research dialogue can be more productive and less open to interpretation. From industry specific terms such as "Case Report Forms" or "Serious Adverse Event" to common terms that have enhanced meaning when used in the industry such as "well-being" or "monitoring", the definitions will be advantageous in decreasing ambiguity in further reading.

Section 2

The Principles of ICH-GCP This section provides 13 bullets that summarize the ethical conduct of research, many of which are elaborated on later in the document.

Section 3

Institutional Review Board/Independent Ethics Committee (IRB/IEC) This section reviews the overall responsibilities of the IRB/IEC, the minimum requirements for establishing and operating one as well as the requirements of their written procedures and record keeping.

Section 4

Investigator This section reviews the investigator's qualification requirements to conduct a study as well as what they must agree to in order to conduct a study. It addresses the resources the investigator must have (i.e. time, property, staff, subject population) and their requirements for medical care of research subjects. The section further addresses the communication requirements with the IRB/IEC that the investigator must adhere to along with accountability of the investigational product and the procedures for randomization or unblinding of such product. The section reviews protocol compliance as well as what to do in the event a research trial must be prematurely suspended or terminated. The section spells out in great detail the specific requirements the investigator must review with the subject to obtain informed consent to participate in the research. The section finally closes with the record keeping obligations and other reporting requirements (i.e. progress reports, safety reports, final report).

Section 5

Sponsor This section details out the obligations of the study sponsor. Included items are quality assurance/control of the study, obligation to use medical expertise and nearly every ethical and operational parameters in trial design and management (including the management of study data and their surrounding records). This section also describes the sponsor's obligation to select investigators that were trained as an investigator according to the GCP standards and their fiscal obligations to that investigator and their study subjects.

Section 6

Clinical Trial Protocol and Protocol Amendment(s) This section details how a scientific protocol can be written to adhere to the international standards. While arguably any scientist can write a protocol, the GCPs require certain topics to be addressed to meet the international standard. This section sets forth the standards from what may be as seemingly banal as a title page to more complex topics such as the requirements for the sections addressing trial design, selection and withdrawal of subjects, safety and efficacy assessments, statistical analysis, quality control, ethics, data handling, record keeping and others.

Section 7

Investigator's Brochure This section, similar to Section 6, details out the standards for writing an acceptable Investigator's Brochure. the Investigator's Brochure (IB) is a compilation of both the clinical and the non-clinical data concerning the investigational product. Again, similar to Section 6, it provides the guidelines from the seemingly banal (i.e. title page, sample table of contents) to the more complex such as what to include in the non-clinical study section as well as the section on effects in humans.

Section 8

Essential Documents For The Conduct Of A Clinical Trial Like the title implies, this section dictates the minimal set of documents required to operate a study of GCP quality. The section divides the documents into three sections (Before, During and After) and specifies where these files should be located (i.e. at the Investigator/institution, at the sponsor or both). These documents would be the ones pulled for an audit by a competent authority of a GCP participant (i.e. the FDA, EMEA or MHLW) or observer, therefore these will likely be what a sponsor and investigator will want to assure are not only completed but filed according to GCP guidance.

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