Harmonisation clinical trials

Two directives were recently introduced to harmonise the conduct of clinical trials in the EU. These are ... 

The next few years will witness a greater partnership between industry, regulatory authorities and universities. Attempts to harmonise the conduct of clinical trials between these three agencies is a positive move. Hopefully, the outcome will be the minimum necessary number of clinical trials, each of which will be designed well enough to make a contribution both to the evaluation of a particular drug development and eventually to the therapeutic armamentarium available for the patient s benefit. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E8 Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London European Agency for the Evaluation of Medicinal Products, 1997. 

International Conference of Harmonisation. E9 Statistical Principles for Clinical Trials, 1998. http / / www.emea.eu.int/pdfs/human / ich / 036396en.pdf, Accessed January 2005. 

With a view to harmonising the conduct of clinical trials across the European Union, Directive 2001/20/EEC was finally agreed on 14 December 2000 and was formally adopted in May 2001 with a 3-year transition period for its implementation. The Directive is now fully implemented in the United Kingdom and further information on clinical trials there can be accessed at the MHR A website. Under the provisions of the Directive, all clinical trials now require a Clinical Trial Authorisation (CTA). This is discussed in detail in Chapter 17. 

Because of these changes, many multinational pharmaceutical companies include the Japanese market into their global development and marketing strategies. It is important to understand, however, that there are still many oddities for conducting clinical trial in Japan. Many of these are due to the difference in medical practice and/or attitude of the Japanese people towards effects and side effects of medicinal products, which may not harmonise with the West in a short period of time. Therefore, it is important to conduct a careful feasibility study before commencing clinical trials in Japan if global development is planned. 

ICH (2009) Harmonised tripartite guideline M3(R2). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals... 

Hsu, J. C. (1996). Multiple Comparisons Theory and Methods. Chapman Hall, London. Hsu, J. C., Chang, J. Y., and Wang, T. (2002). Simultaneous confidence intervals for differential gene expressions. Technical Report 592, The Ohio State University, Columbus. ICH E10 (1999). Choice of Control Groups in Clinical Trials. CPMP (Committee for Pro-pritary Medical Products), EMEA (The European Agency for the Evaluation of Medical Products), London, Draft ICH (International Conference on Harmonisation). Efficiency guidelines, http //www.ich.org. 

All participants in a clinical trial must respect ethical and professional principles and guidelines such as the Helsinki Declaration and the International Conference on Harmonisation (ICH) guidelines for GCP. 

Furthermore, it is strongly recommended that investigators, sponsors, monitors, and all others involved in clinical trials adhere to international standards for the proper management of clinical trials (i.e., GCP released by the International Conference on Harmonisation, involving the European Medicines Evaluation Agency [EMEA], and the agency s counterparts in other countries [United States and Japan]). 

The procedures for assuring quality of clinical trials have evolved over the past 30 years, culminating in several published guidelines. There are three key GCP documents - the GCP guidelines of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), the Code of Federal Regulations (21 CFR) of the United States, and the Declaration of Helsinki. In today s global climate, the pharmaceutical physician should work to ICH GCP, of which the Declaration of Helsinki is the foundation. 

With a view to harmonising the controls on clinical trials, a draft Directive concerning the conduct of clinical trials in the EU was submitted to the European Parliament by the Commission in September 1997. After three years of difficult negotiations, a EU Directive aimed at harmonising the requirements for clinical trials in the European Union was finally agreed on 4 April 2001 by the European Parliament and Council and formally adopted in May 2001 with a three-year transition period for its implementation by 1 May 2004. 

International Conference on Harmonisation. Guidance for Industry E9. Statistical Principles for Clinical Trials. CDER, FDA, Rockville, MD, 1998. 

---