Clinical trials play an essential role in scientific innovation by testing the effectiveness of emerging medical treatments. Closely monitored, the human participants help researchers explore an experimental treatment’s safety, efficacy, effectiveness, and potential side effects. Trial administrators use several key strategies to prevent bias during this process, including randomization in clinical trials. By depending on chance alone, randomization removes any element of human choice and provides more effectual results.
Randomization in Clinical Trials
What Is Randomization?
Randomization, also known as random assignment, is the process of assigning participants by chance, rather than by choice, to different treatment groups. For example, one group of participants (known as the investigational group) may receive the new experimental treatment, while another group (known as the control group) receives the standard treatment or a placebo treatment for comparison. Random assignment ensures that each participant has the same opportunity to be assigned to any given group. Typically, a computer is used to randomly assign patients to groups.
It is important that the two or more groups of participants in a clinical trial are as similar as possible, except for the treatment they receive. This ensures that the researchers can confidently conclude that any differences in outcomes between the groups are due to the treatment being studied.
Why Is Randomization Important?
The goal of randomization is to minimize bias. Bias can affect a trial’s results, whether it be through conscious human choices or less direct factors. For example, if doctors could choose which participants received which treatment, they might assign participants to treatment groups based on the severity of their symptoms or their ages. This bias would exaggerate or hide the effects of the treatment and make the trial results unreliable. Using chance to assign participants to groups allows researchers to compare the treatment or intervention to alternatives (like the standard treatment or no treatment) more fairly. Randomization in clinical trials is one of the best ways to minimize the probability of biased study results.
To further reduce the likelihood of biased conclusions, many clinical trials are also double-blinded. This means that neither the participants nor the researchers know whether an individual subject is receiving the test treatment or the control.
What Trial Participants Should Know
Properly randomized clinical trials pave the way for life-changing medical advancements. However, if you are participating in a randomized clinical trial, you should know that you may or may not receive the treatment being tested. Neither you nor your doctor can choose whether you receive the experimental treatment, the standard treatment, or a placebo. So before consenting to participate in a clinical trial, be sure that you understand the protocol, and don’t be afraid to ask questions if you don’t. Talk to your doctor about the best option for you and your health before embarking on a clinical trial.
Randomization in clinical trials is essential to ensuring that no accidental, intentional, or perceived bias interferes with the scientific integrity of research.
Have you ever thought about taking part in a clinical trial? QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. If you would like to join us in this mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of FAQ.