Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What method can be used to maintain the blind in a clinical study during the administration of supplies?

1. Single-blind

2. Masking

3. Double-dummy

4. Open-label

The correct answer is: Double-dummy

In the context of clinical studies, the double-dummy method is an effective strategy for maintaining blinding, particularly when a trial involves the comparison of two different interventions. This method is especially useful in scenarios where participants and researchers must remain unaware of the treatment assignment to prevent bias and ensure the integrity of the trial's results. The double-dummy approach works by administering two different treatments, ensuring that each participant receives a placebo for the treatment they are not receiving. For example, if two different drugs are being tested against each other, participants in both arms would receive a formulation of their assigned drug and a matching placebo for the alternative drug. This way, both the participant and the researcher remain blinded regarding which treatment is being actively administered. In clinical research, maintaining the blind is crucial for reducing bias, enhancing the validity of the results, and preventing participant expectations from influencing outcomes. The double-dummy method effectively addresses the complexity that may arise when trials involve different dosages, delivery methods, or types of interventions. This maintains a higher level of rigor and reliability in the study's findings.