title: Clinical trials in support of medical devices.
abstract: 1. Clearly specify the hypothesis to be investigated using clinically meaningful objective endpoints. 2. Collect all patients' data in a reliable and consistent manner. 3. Use statistically appropriate procedures to analyze the data. 4. Conclusions should be able to support all claims of safety and effectiveness that are to be made.
authors.affiliation: Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors.forename: R
authors.initials: R
authors.lastname: Kotz
mesh_terms: D015670:Acupuncture Therapy / Q000295:instrumentation; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D003625:Data Collection; D004869:Equipment Safety; D004864:Equipment and Supplies; D006801:Humans; D017063:Outcome Assessment, Health Care; D011336:Probability; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data; D018401:Sample Size; D014481:United States; D014486:United States Food and Drug Administration