Streamlining Clinical Trials Review Process To Speed Up Delivery Of Drugs To Those In Need
In this Atlantic opinion piece, Amanda Glassman, director of Global Health Policy at the Center for Global Development (CGD), reports on how “lengthy, inefficient review processes” or “non-existent regulatory capacity” in some developing countries for drug and vaccine candidates waiting in the pipeline is keeping new medicines, vaccines, and diagnostic techniques from reaching millions in need. Glassman highlights a number of trials that were delayed due to regulatory and ethical approval processes, writing, “Not only do these delays prevent access to effective treatments by a growing number of patients,” but “they can lead to unnecessary costs that eat away at already small budgets to find new cures for neglected diseases.”
Glassman discusses the idea of a regional regulatory pathway recommended by the CGD’s Clinical Trials and Regulatory Pathways for Neglected Diseases Working Group “that would increase regulatory capacity, reduce inconsistencies, and speed product development and delivery in neglected disease-endemic countries,” and writes, “This approach would offer a single review process with definitive timelines and requirements without undermining the sovereignty of the countries involved.” She concludes, “Clinical trials produce goods that span entire regions and, as such, they need a system of regulations to match. Reducing inhibitory costs and bureaucratic hold-ups would benefit the estimated one billion people that suffer from neglected diseases — be it malaria, [tuberculosis], or other lesser known diseases — every year” (11/14).