According to an article on Outsourcing-Pharma.com, a new study indicates that the regulation of clinical trials in other regions of the world is too rigorous, urging pharma firms and CROs to create designs that are universal.
The article entitled, “Trial regulation in emerging markets is now “too stringent,” says new report,” points out that emerging markets were once avoided due to a lack of protocol, but now that has gone to the opposite extreme, and researchers are being too careful. These strict regulations are pushing them away from tailoring their trials for their specific risks and complexities, and there is a possibility of a decrease in the number of trials being conducted in these regions due to the price increase.
Although it may look like the fault is solely on the regulators, the report states that sponsors and CROs do not have enough trust in locally run research sites to be able to run their own high quality and compliant trials.
To read the full article, click here. To read the study, click here.