Clinical Trials: Regulatory Considerations and International Harmonization
Clinical trials are experiments that are carried out in clinical research. They are designed to provide knowledge on detection, prevention, and treatment of diseases as well as other biomedical interventions and new treatment discoveries. One important aspect of clinical trials is the generation of data on safety and efficacy, which require that sponsors get the approval of regulatory bodies and ethnic committees in every country they operate in. However, sometimes, language and culture dissimilarities present challenges that inhibit their effectiveness in foreign territories. This text takes a look at bridging studies and harmonization technologies which are used to reduce the adverse effects that may be brought about by globalization.
Discussion 1: Bridging Studies
Do you think that bridging studies should be required for the development of drugs that companies plan to market in other cultures?
Drug manufacturers today rely on the globalization of pharmaceutical products for their success, but sometimes, sponsors face challenges because populations in different regions differ due to ethnic factors. In such instances, bridging studies are used. A bridging study is the additional study in a new region to bridge the gaps that may arise in clinical data due to dose response, safety, and efficacy. In light of the ethnic sensitivity a newly developed drug poses in different regions, bridging studies should be carried out for all the drugs that are to be marketed in other cultures.
Bridging studies are important because when ethnic dissimilarities...
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