It is widely accepted that patients participating in clinical trials are less than perfectly compliant with their medication regimens. The extent to which non-compliance affects the results of clinical trials […]

The problem of having patients determine their own dosing during clinical trials is widely recognized. If data obtained in clinical trials where patients take medication once or twice a day […]

Clinical trial costs are spiralling out of control. Studies generally estimate the cost of bringing an Investigational new drug (IND) to market at $1B although there is considerable variability in […]

“At some point, perhaps not in the far future, it will seem as wrong to run a clinical trial without compliance measurement as without randomization.” B. Efron, Statistics in Medicine, 1998 […]

The classical approach to decision-making in clinical research is the randomized trial. Patients are assigned to treatment conditions according to sample sizes that are determined a priori by power calculations. […]

A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated approach to ensuring the safety of medications. The baseline for ensuring the safe use of prescribed medication is professional labelling. […]