The dos and donts of randomization in clinical trials

Randomized trials in clinical research organization hold high significance due to the ability to prevent experimental unfairness. The randomized clinical trials reduce evaluation variability by eliminating bias factors from the experimentation. Every individual or human volunteer participating in the clinical trial gets an equal chance of specific treatment for a particular illness or disease. Additionally, the method naturally forms intervention groups for the assessment of statistical data.

There are various benefits of randomized trials:
• Elimination of bias of selection.
• Balancing of analytical variables (unknown and known).
• The assumption-free treatment basis is formed for experimentation.
The criteria for randomized trails are given below:

Simplicity

The execution of randomized clinical trials is easier for the lab scientists and analysts as the active or placebo treatment is assigned to the patient randomly at the time of trial.

Unpredictability

Every involved participant can either receive active or placebo treatment. The in-charge scientists and the volunteers also don’t know of the treatment that would be assigned to a particular clinical trial volunteer.

Balance

Both the active and placebo treatment groups are formed such that there are no differences in size and other important experimentation aspects. This allows easy assessment of analytical parameters and characteristics.

Key Elements of Randomized Trials

In randomized clinical laboratory services, the blinding ensures unbiased clinical trial completion. Here are some steps that clinical research organizations should follow for reliable execution of the experiment.

Do(s)
• While there are various methods for blinding such as human selection and blinding through envelopes, an interactive response technology is most favorable. Using an IRT eliminates the occurrence of human bias and errors under any circumstances.
• An audit trail of patients who have entered the trial, on which date, and the type of treatment that is received should be maintained. This allows analytical assessments later in the clinical trial. This information is also necessary to monitor the health of the volunteer as per the guidelines of the administered drug.
• Data integrity is a key element in randomized clinical trials as it forms the basis of the trial. The high-security system should be developed for an online structure and high-security policies should be formed for other methods. If the data leaks, the chances of bias in the clinical trials increase, which negates the purpose of the randomized trials.
• The appropriate block size should be selected for randomized trials. A small block size can increase the risk of bias and large block size can create an imbalance in the experiment.
• For both online and offline system, proper access hierarchy should be formulated to avoid unblinding of the experiment.

Don’t(s)
• Don’t form more stratification factors than required as it can cause an imbalance in the experimentation. You may not get the required subjects for all the stratification factors, which may reduce the significance of the experiment.
• Don’t ignore user credential authentication in the online randomization mechanism.
Randomized clinical trials are the foundation of many clinical research organizations. It is necessary to ensure that these randomized trials are executed with unbiased factors avoiding unblinding of the experiment under any circumstances.

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