Good Clinical Practices

Ketan Zota,
Chairman - Zota Healthcare

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. This article illustrates the importance of Good Clinical Practice, defines and outlines its goals.

Clinical practices are regulated by Good Clinical Practice (GCP), which is an internationally acknowledged document which regulates certain requirements of the members like investigators, sponsors, monitors and IRBs, responsible for the conduct of clinical trials. GCPs incorporate aspects such as designing, archiving and reporting clinical trials that are concerned with humans as subjects. The aim of GCP is to make sure that the studies are authenticated scientifically and that the clinical properties of the investigational outcome are appropriately filed.

There are certain organizations which have to abide by the standards of GCP and they are pharmaceutical companies, clinical laboratories, charities, universities, NHS hospitals, GP practices and contract research organizations. Acquiescence with GCP pledges in providing an assurance, publically, of the protection and consistence of the trail subjects' well -being, safety and rights. The standards are achieved through quality assurance and inspections.

The guidelines for good clinical practices which will be discussed further have been provided by International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).
The conduction of clinical trials has to be in link with the ethical principles that are originated in the Declaration of Helsinki which are also congruous with GCP and the pertinent regulatory wants. Before initiating a trial, foreseeable risks and troubles should be measured against the probable advantage for the individual trial subject and society. Only after anticipating the benefits which will justify the risks, a clinical trial should be initiated and carried forward. The concerns of science and society are less significant than the well-being, rights and safety of the trial subjects. The clinical and nonclinical information on an investigational product which is available has to be satisfactory to support the proposed clinical trial.

Clinical trials have to be scientifically appropriate and the protocol in which it is described should be clear and detailed. Only a qualified physician or a qualified dentist possesses the right to take medical decisions and only he/she can govern the medical care of the subjects. A good clinical practice involves the participation of only those individuals who are educated, trained and experienced to perform his respective tasks. The consent which is given freely by the subjects should be acquired before their participation in any clinical trial. An accurate report, analysis and affirmation are possible only if the information of the clinical trials are handled, recorded and stored in an appropriate manner. The privacy and confidentiality rules by applicable regulatory requirements should be respected in terms of maintaining confidentiality of the identity of the subjects. The Good Manufacturing Practice (GMP) is the only body responsible for manufacturing, handling and storing the investigational products. The products have to be used in accordance with the protocol. The implementation of the system complying procedures is necessary to assure the quality of the trial's each aspect.

A clinical trial should be performed in accordance with the protocol that has received, in prior, the opinion from independent ethics committee (IEC) or institutional review board (IRB). The qualifications of the investigator have to be taken into account through his curriculum vitae or any other documents as demanded by IEC/IRB. The IEC/IRB should conduct reviews on each ongoing trial either at intervals or per year. The investigator is restricted to participate in any deliberations of the IEC/IRB; he is just allowed to provide some amount of information in the context of trial. The IEC/IRB should provide a written approval for the admission of a subject to a trial.

A Clinical trial is considered complete and safe when each step is well analysed and performed. The risks involved should be equally justified. The products involved should also be investigated properly in accordance with the protocol in order to ensure the positive outcome of the trial.

When an investigator is put into picture, it is necessary that the investigator is educated, trained and experienced for conducting the clinical trial properly. He has to comply with Good Clinical Practice. In order to conduct the trial safely and properly, the investigator needs to have adequate facilities and qualified staff. The responsibility of all trial-related medical decisions falls on the qualified physician who acts as an investigator of the trials. Though the subject is not liable to give any reason for withdrawing from a trial, an investigator has to make an effort to know the reasons, while respecting the subject's rights. It is the investigator's responsibility to have all the required documents to be supplied to the subjects before the clinical trial. Neither the investigator nor the trial staffs possesses any rights to influence the subjects to participate in the trial. The language containing the information about the trial should be non-technical and understandable by the subjects. If the trial is suspended or prematurely terminated for any reason, the trial subject has to be promptly informed by the investigator.

If a sponsor makes any agreement with either the investigator or any other parties in involvement with the clinical trial, it has to be formulated in a written document as part of the protocol. The trial related medical questions has to be answered by a qualified medical personnel appointed by the sponsor. The sponsor has to ensure the proper utilization of the individuals like clinical pharmacologists and physicians to be done at every level of the clinical trial process. The financial aspects of the clinical trial have to be timely documented in an agreement between the investigator and the sponsor. Noncompliance by any member of the clinical trial should be dealt promptly and compliance should be secured by the sponsor.

In terms of multicenter clinical trials, the communication between the investigators is required. A trial design should include the description of the design of the trial and a schematic diagram of its procedures and stages . The criteria for the termination of the trial should also be stated. The Investigator's Brochure is a compilation of the clinical as well the nonclinical data on the investigational products that are in relevance with the study of the products on human subjects. It is necessary to have in hand , the summary of each completed trial.

Essential Documents are significant because they regulate the evaluation of a clinical trial and also determine the quality of the produced data. These documents are developed before, during and after the clinical conduct of the trial. At the beginning of the trial, it is necessary to establish trial master files. Only after the monitor has reviewed all the documents, will the trial will be closed. Lastly, all the documents have to be available for audit and inspection.