Sicker patients in clinical trials the new status quo

David David Pittman from medpagetoday.com has written an article on FDA’s push to include sicker patients in clinical trials. In the article David brings up the new internal memo that requests drug reviewers to push for a broader population in trials. By doing this it will allow for a better view on the “real world effect” the drug will have on the general population. A study from Digital Infuzion from 2011 showed that 2/3 of studies excluded patients with heart disorders, 71% excluded people with psychiatric disorders, and 38% left out people with diabetes. Bob Temple, MD, the deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, said that the widespread exclusion of those with hints of psychiatric disorders troubled him because so many drugs are found to cause increased rates of depression. To read the full article click here.