Randomization Procedures: The Case for Strong Encryption

Through comparative effectiveness research in general, and clinical trials in particular, investigators gain insight into the prevention, diagnosis, and treatment of various illnesses. For this insight to be valuable to patients, the clinical trials must, to the extent possible, reflect the reality that governs the situation. The purpose of randomization in clinical trials is to create comparable comparison groups [1]. This involves minimizing vulnerability to the prediction of future allocations, and selection bias [2]. Allocations that can be predicted can also be exploited to create an unfair advantage for the preferred treatment group. That is, better responders can be enrolled for one treatment and worse responders for another [3]. It is this concern over selection bias that has led to the widespread use of allocation concealment in clinical trials [4].