Good Case Study On Placebos And Recent Ethical Controversy In International Research
Ethnic factors that are, genetic, physiologic, environmental and cultural factors affect the medicines effect on the users. This has made it necessary to conduct certain tests before developing or adopting medicine that is used in different regions. Repeating the whole drug trial is not needed when the complete clinical data package can be extrapolated. The dosage response, safety and efficacy of the drug should meet the regulatory standards of the new region. In case the foreign clinical data is inadequate, additional clinical trials may be required to assess drug-drug interactions, different comparators for different dosage and dose regimen. The efficiency of the medicine may or may not be affected by ethnic factors. Bridging data package and studies are used to provide additional clinical data for efficacy, safety, dosage and dose regimen to allow for extrapolation of the complete clinical data in the new region.
Experimental treatment regimes are sometimes faced with ethical controversies especially where the same drug has been tested before, and the efficacy of the drug established. In the case of the testing a lower dose of ACTG 076 in HIV-positive women, it was deemed unethical because it would be withholding effective treatment to the women in the research study. However, placebo-controlled studies testing a lower dose of ATZ seemed acceptable in developing countries. The argument for the tests was that the women who participated in the study would not be left worse off. The already established regimen in developed countries was unaffordable and benefits of availing an effective less expensive regimen.
Is it unethical to use placebo-controlled trials when testing new regimen when an already effective regimen has been established? It is unethical because participants in the study will be denied the opportunity to access and use the already established regimen, by that leaving them worse off.
What should sponsors who develop medicine do to ensure increased chances of acceptance in new regions? The sponsor can consider how ethnic factors influence the safety and efficacy of the medicine. They should also ensure that clinical trials are complete and meet the standards and regulatory requirements of the new regions.