Review process clinical trials

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Institutional Review Boards (IRBs) in the Clinical Trial Process... 

Summary The summary presents the case for the drug s approval. It includes discussion about the drug s mechanism of action, its effect on animals, results of clinical trials, manufacturing and tests methods, its stability, and proposed dosage and treatment protocol. The summary may run into hundreds of pages. It is one of the few documents being read by all the different reviewers as such, a good summary will assist with the review process. 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

The basic ethical questions raised by clinical research should never be underestimated. The pharmaceutical physician will need to be aware that failure, intentionally or because of misguided enthusiasm, to protect the health and well-being of each study subject can have very serious consequences. In an age where the medical profession is constantly under scrutiny, the drug industry is heavily criticised and the communication industry extremely active, mistakes in clinical trials are pimished. Therefore, before a study is commenced, a review should be made that the scientific approach is current, the motivation is clear, the processes are imambiguous, and there should be sufficient data to judge the safety and effectiveness of the interventions proposed. 

Mention has already been made of the new Directive on the protection of individuals when processing personal data and on the free movement of such data (Directive 95/46/ EC) At this time, the maimer in which this Directive wiU be applied to data from clinical trials is stiU under review. However, the ICF needs to state the rights of the study subject. The subject will be told who controls the confidential data relating to him or herself, the purpose for which it is being collected... 

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