Which concerns arise when new medications are tested in developing countries?
Low- and middle-income countries are increasingly selected as locations for international clinical trials to tests the safety and efficacy of new drug candidates. But what are the consequences of this development for these countries?
In his recently published book chapter, Dr Bastian Rake affiliated researcher at the U-GOT KIES centre discusses the extant literature related to this question and identifies three main —partially interrelated— concerns: a lack of contribution to building up local innovation capacity, a lack of local regulatory capacity, and the prevalence of questionable clinical research practices and fraud. Long-term capacity-building efforts of local researchers and regulators is a priority to address these concerns.
Controversies with Clinical Trial Regulations in Low- and Middle-Income Countries
The title of the book is Controversies with Clinical Trial Regulations in Low- and Middle-Income Countries. Link: https://doi.org/10.1007/978-3-030-99680-2_23
Dr. Bastian Rake is Lecturer / Assistant Professor and Director of Strategy and Risk, at Maynooth University School of Business, Ireland.
Learn more about Bastian Rake here: https://www.maynoothuniversity.ie/people/bastian-rake