FDA report on trial barriers and strategies
The FDA has released a document in regards to the recruitment criteria of the patient, i.e. inclusion and exclusion criteria necessary to recruit a targeted population. The main aim is to increase diversity to improve the quality of work being produced. The exclusion of patients with chronic health diseases, pregnant, elderly and pediatric patients will lead to a decrease in data produced for such populations. This decreases the information on drug efficacy and risks for such patients although these drugs are administered to the patients. Hence, it is necessary to understand the effects of such drug, and analyse if such exclusions are necessary.