CTTI Identifies Covid-19 Trial Best Practices

The Clinical Trials Transformation Initiative (CTTI), a joint venture of FDA and Duke University, says it has identified eight best practices for designing and conducting Covid-19 treatment clinical trials. “While these best practices, comments, and quotes are specific to Covid-19 trials, CTTI recommends that these principles should be used for all clinical trials, in line with CTTI Quality by Design recommendations,” the group says. The best practices are: 

•          learn from the past and what’s being done now;
•          make the time to design right, but move quickly;
•          adequately power the trial;
•          randomize the trial;
•          maintain human research protections;
•          collaborate on study design;
•          engage and enroll racial and ethnic minorities; and
•          use a core set of inclusion and exclusion criteria and endpoints.