J Altern Complement Med. 1996 Spring; 2(1): 45-8; discussion 49-51.

Clinical trials in support of medical devices.

Kotz R.

Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.

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.