Lesson 8: Treatment Allocation and Randomization

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Introduction

Treatment allocation in a clinical trial can be randomized or nonrandomized. Nonrandomized schemes, such as investigator-selected treatment assignments, are susceptible to large biases. Even nonrandomized schemes that are systematic, such as alternating treatments, are susceptible to discovery and could lead to bias. Obviously, to reduce biases, we prefer randomized schemes. Credibility requires that the allocation process be non-discoverable. The investigator should not know what the treatment will be assigned until the patient has been determined as eligible. Even using envelopes with the treatment assignment sealed inside are prone to discovery.

Randomized schemes for treatment allocation are preferable in most circumstances. When choosing an allocation scheme for a clinical trial, there are three technical considerations:

  1. reducing bias;
  2. producing a balanced comparison;
  3. quantifying errors attributable to chance.

Randomization procedures provide the best opportunity for achieving these objectives.

Learning objectives & outcomes

Upon completion of this lesson, you should be able to do the following:

  • Identify three benefits of randomization
  • Distinguish simple randomization from constrained randomization.
  • State the purpose of randomization in permuted blocks.
  • State the objective of stratified randomization.
  • Contrast the benefits of permuted blocks to those of adaptive randomization schemes.
  • Use a SAS program to produce a permuted blocks randomization plan.
  • Use an allocation ratio that will maximize statistical power in the situation where greater variability is expected in one treatment group than the other.
  • Provide the rationale against randomizing prior to informed consent.