Mechanisms for strengthening clinical research: the Colombian experience

Pineda Velandia et al.

This article describes the regulatory changes and procedures introduced in Colombia that created favorable  technical conditions for clinical trials of drugs in the country. The impact of these measures was measured in terms of the number of research centers certified in good clinical practice, the time taken to evaluate clinical trial protocols, and the quality of the concepts developed. Using public information sources or data from the literature, the study found that adoption of the regulation requiring certification in good clinical practice and the change in the procedure for evaluating clinical trial protocols contributed to the quality and timeliness of clinical research in Colombia. Nevertheless, it is clear that the strengthening of regulatory agencies should be accompanied by the review and amendment of the regulations governing other actors in the clinical research ecosystem to guarantee the safety of clinical trials and that more studies should be conducted in the country.

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