Certified Clinical Research Associate (CCRA) Practice Exam

What design techniques are most important for avoiding bias in clinical trials?

1. Blinding and stratification

2. Randomization and partial blinding

3. Blinding and randomization

4. Stratification and random sampling

The correct answer is: Blinding and randomization

The most important design techniques for avoiding bias in clinical trials are blinding and randomization. Blinding is a method that prevents participants and/or researchers from knowing which treatment the participants are receiving, which minimizes the influence of expectations on the outcomes. It helps to ensure that the results are not affected by participants' or investigators' biases, leading to more objective and reliable data. Randomization involves assigning participants to treatment groups in a random manner, which helps to ensure that the groups are comparable at the start of the trial. This process reduces selection bias and balances both known and unknown confounding variables, allowing for valid conclusions about the treatment's efficacy. While stratification can be valuable by ensuring that specific subgroups of participants are evenly represented in treatment groups, its primary focus is not directly on bias avoidance but rather on ensuring balance among important variables. Similarly, partial blinding may still introduce elements of bias if the blinding is not fully effective. Therefore, the combination of blinding and randomization is crucial for minimizing biases and enhancing the credibility of the trial’s results.