Randomized Controlled Trial - Randomization

Randomization

The advantages of proper randomization in RCTs include:

• "It eliminates bias in treatment assignment," specifically selection bias and confounding.
• "It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors."
• "It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance."

There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be "restricted," or may be "adaptive." A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random "systematic" methods of group assignment, such as alternating subjects between one group and the other, can cause "limitless contamination possibilities" and can cause a breach of allocation concealment.