Hi All,
Great comments, and I do agree repeatability and traceability are vital for a clinical study, and it really comes down to is how many patients can be monitored and evaluated, because as Luisa mentioned, if there are not staff members to evaluate a clinical study, then the quality of the trail may diminish. Patient evaluation is very vital during these studies, because potential flaws due to drug or device use can be addressed. One last interesting consideration is the sampling of the patient population, like how similar to eachother must the patient population be or more importantly what variability is needed within this population to prove that the device or drug being tested is considered a good representation for the general population.

Chris