Worldwide, many organisations and committees issued various documents and guidelines on the same issue, and a decision was taken to consolidate all these guidelines into one universal guideline to be used globally.
This guideline was approved on 17 July and implemented for clinical trials from 17 January The participants of these guidelines were representatives of authorities and pharmaceutical companies from the EU, Japan and the United States as well as those of Australia, Canada, the Nordic countries and WHO [ 8 ]. The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and consistent with the principles of the Declaration of Helsinki, and that the clinical trial data is credible [ 8 ]. A historical background of the reasons and the importance of GCP is summarised in Table 2. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement s.
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interest of science and society.
The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. Clinical trials should be scientifically sound, and described in clear, detailed protocol. The medical care given to, and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task s. Freely given informed consent should be obtained from every subject prior to clinical trial participation. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement s. Investigational products should be manufactured, handled and stored in accordance with applicable Good Manufacturing Practice GMP.
They should be used in accordance with the approved protocol. Systems with procedures that assure the quality of every aspect of the trial should be implemented. All clinical trials should be conducted in accordance with ethical principles, sound scientific evidence and clear detailed protocols. The benefits of conducting trials should outweigh the risks.
The rights, safety and well-being of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality. The care must be given by appropriately qualified personnel with adequate experience. Records should be easily accessible and retrievable for accurate reporting, verification and interpretation. Investigational products should be manufactured according to Good Manufacturing Practice 8.
It is also important to mention the participants of GCP in clinical trials and their respective responsibilities. These are summarised in Table 3. Since the conception of the ICH-GCP guidelines, many countries in the Asia-Pacific region realised the need to formulate guidelines of their own based on the framework of the original guidelines [ 7 ].
This is clearly seen in Table 4 that tabulates the adoption of GCP in our country and its neighbours. In Malaysia, similar guidelines were formulated in the wake of greater demand by the pharmaceutical industry to conduct clinical trials in the country. To know the answer to this, we have to look to the historical background that led to the formulation of GCP guidelines in the United States and Europe and also to the formation of the ICH. The events that led up to the culmination of the ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects.
TGA comment: Further information about requirements for obtaining informed consent in special cases can be found in the National Statement. TGA comment: The Australian trial sponsor retains overall responsibility for the conduct of the trial in Australia. TGA comment: The TGA requires records to be retained by the trial sponsor for at least 15 years following the completion of a clinical trial.
However, in Australia, the overriding consideration for trial sponsors with respect to record retention is the issue of product liability and the potential need for sponsors of products to produce records at any time during, and possibly beyond, the life of a product in the event of a claim against the sponsor as a result of an adverse outcome associated with the use of the product.
This in turn led to delays in getting the product to market and created an increase in the costs to the pharmaceutical industry.
The solution to this problem came about in when a series of conferences were held in order to unify the differing codes of practice.
All parties from various countries agreed to follow the same code of good practice, leading to an internationally recognised, uniform standard to which all countries could commit. It provides guidance on such issues as.
The European Commission control the legislation on pharmaceuticals throughout the European Union. In it published a directive that would make GCP a legal requirement across all member states.
It also stated that this legislation must be transposed into the laws of each member state by May and is applicable to all clinical trials on human subjects that involve medicinal products. It had made GCP a legal requirement and all trials involving investigational medicinal products must now be conducted to the same GCP standard, there would also be mandatory inspections by the MHRA.
Informed consent was a particular issue in this directive and it provided added protection to vulnerable groups of people unable to give legal informed consent for themselves. Among many other specifications it also encouraged the development of national ethics committees operating within a legal framework and suggested firm deadlines for the approval of research projects and protocols.
It confirms the importance of ICH — GCP and states that all clinical trials should be conducted in accordance with the version of the Declaration of Helsinki. It also states that sponsors retain responsibility even if they delegate functions, and specifies the sponsor responsibilities in relation to reporting Serious Breaches in GCP. Having achieved prior ethical approval to do so this amendment allows incapacitated adults in certain emergency situations to participate in research trials without the consent of a legal representative.
However, this only applies when the treatment is required urgently and when it is not reasonably practical to meet the conditions of obtaining informed consent. We can now understand the rationale behind the development of Good Clinical Practice and that it is a set of interwoven laws and guidelines that together provide the foundation for high quality processes in clinical research.
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