Notizia - Recent Pharma, Healthcare and Biotech Happenings

Use of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary. The FDA said sometimes the use of a placebo can present practical or ethical concerns in double-blind, randomized trials conducted in development programs for drugs products for the treatment of malignant hematologic and oncologic disease. In its three-page draft guidance, which was first reported by RAPS, the FDA said that because of the toxicity profile of the active treatment, patients and investigators can infer which treatment is ...