Regulatory Considerations and International Harmonization: Clinical Trials Essay

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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.

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Bridging studies are important because when ethnic dissimilarities are evident, but extrinsic factors like the design, medical practice and the conduct of clinical trials are similar, they provide assurance that the safety, efficacy and doses that come from the original region are applicable in the new region (National Center for Biotechnology Information, 2015). Before, sponsors often had to duplicate majority of foreign clinical data in adherence to regulatory requirements in new territories. Bridging studies reduce this duplication by applying one main clinical data package and only conducting the necessary additional tests that are required to confirm safety and efficacy. Moreover, when properly executed, bridging studies lead to discoveries that will be useful in future research and development efforts.

Discussion 2: Harmonization of Technology

Why is the effort to standardize the language used in reporting clinical trials (MedDRA) important to harmonization throughout the world?

The Medical Dictionary for Regulatory Activities (MedDRA) is a highly specific medical terminology dictionary and thesaurus that is used to facilitate the sharing of regulatory information regarding medical products. It was developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and it is used in the documentation, registration, and safe monitoring of pre-marketing and post marketing activities (MedDRA, 2013).

MedDRA is important because it enables drug and device companies to analyze medical history and adverse effects. It makes it easier for practitioners to.....

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