Question13. Why do we need harmonisation?
Harmonization in Clinical Trials –
Harmonization is Global Standards that are widely accepted, this principle today is valid for many things. What does the international harmonization (or harmonize local standards to international standards) mean?it means that every country must share the ownership of an international standard, and every body should equally benefit from the international standards. How to make it as real? There are two key things to be noticed.
All countries must speak their requirements up to the international discussion, at the early stage of the development of the international standard in an adequate form for the discussion like it was on ICH in 60-s. The only country that has technical/marketing advantage may take a leadership of the discussion and control of the resultant standards.
Harmonisation is a very important factor in clinical trials and in Pharmaceutical industry.we needed harmonization in the interest of the patient and public to avoid unnecessary duplication without compromising the regulatory obligation of safety, quality and efficacy
One of the objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
The need of harmonization arises with the realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. In the United States a tragic mistake in the formulation of a children’s syrup in the 1930s was the trigger for setting up the product authorization system under the Food and Drug Administration. In Japan , government regulations requiring all medicinal products to be registered for sale started in the 1950s. In many countries in Europe the trigger was the thalidomide tragedy of the 1960s, which revealed that the new generation of synthetic drugs, which were revolutionizing medicine at the time, had the potential to harm as well as heal.
In early 1960s and 1970s we saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products. The industry, at the time, was becoming more international and seeking new global markets, but the registration of medicines remained a national responsibility. Although different regulatory systems were based on the same fundamental obligations to evaluate the quality, safety and efficacy, the detailed technical requirements had diverged over time to such an extent that industry found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products, internationally.
The urgent need to rationalize and harmonies regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonisation (ICH) guidance provides a unified standard for the European Union, Japan , and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and that the clinical trial data are credible.
ICH has been successful in achieving harmonisation, initially of technical guidelines and more recently on the format and content of registration applications. New approaches to the maintenance of the products of harmonisation is needed. In addition, further harmonisation activities should be continued in a focused manner.
MAIN PRINCIPLES OF ICH GCP
1) Clinical trials should be conducted in accordance with the ethical principles that that are consistent with GCP and the applicable regulatory requirements.
2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
3) The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
4) The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
6) A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
7) 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.
8) Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
9) Freely given informed consent should be obtained from every subject prior to clinical trial participation.
10) All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
11) The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.
12) 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.
13) Systems with procedures that assure the quality of every aspect of the trial should be implemented.
« Question04. What could have happened if IRB-s were not created? Question14. As a CRA you have been given the task of finding potential investigative sites for the clinical trial of a new drug that would treat AIDS. Please find and list 3 potential sites in the United States and give their profiles? »