Newsletter - March 28, 2019
FDA Suggests Alternates to Placebo Control for Pivotal Clinical Trials
It is hard to conduct placebo-controlled clinical trials, particularly in rare diseases. FDA released a new guidance document last week that provides ways to use historical controls to reduce and possibly eliminate placebo controls in all clinical trials. All diseases have a natural course under available standard of care which....Read More
Need Minority Patients in Your Trials, Find Minority Investigators
Minorities represent a small fraction of subjects participating in clinical trials. A good way to improve minority participation in clinical trials could be through investigators from these communities. In an essay published this week, Dr Kyle Mack, a Chicago doctor, who is African-American describes how being from the...Read More
FDA Suggests Alternates to Placebo Control for Pivotal Clinical Trials
It is hard to conduct placebo-controlled clinical trials, particularly in rare diseases. FDA released a new guidance document last week that provides ways to use historical controls to reduce and possibly eliminate placebo controls in all clinical trials. All diseases have a natural course under available standard of care which....Read More
Need Minority Patients in Your Trials, Find Minority Investigators
Minorities represent a small fraction of subjects participating in clinical trials. A good way to improve minority participation in clinical trials could be through investigators from these communities. In an essay published this week, Dr Kyle Mack, a Chicago doctor, who is African-American describes how being from the...Read More
