The phrase “randomized clinical trials” may sound intimidating or overwhelming. You may not know exactly what the term “randomized” means, or what participating in one of these trials might entail. Before you decide to participate in one, there are a few things you should know.
To quell any fears you may have, we’ll explore what these types of clinical trials are like, what they mean, what placebo versus treatment groups are, how they work, and what you should understand before you take part in a similar trial.
In a randomized clinical trial, subjects are randomly split into different groups and given different treatments, according to the National Cancer Institute (NCI). One group receives the researched treatment, while others receive standard care or a placebo, an inactive treatment or medication. The participants are not aware during the trial of which treatment they have been given.
Joseph Mikhael, MD, Medical Advisor for the International Myeloma Foundation, an IMF Scientific Advisory Board member, and a member of the IMF’s International Myeloma Working Group, explained the meaning of randomization.
“[Randomization] means that there is more than one treatment arm in the trial, and when patients join the study, they are randomly assigned (not by their choice or the doctor’s) to one of the treatment arms,” Dr. Mikhael explained.
To ensure fairness and accuracy in medical research, these trials randomly assign participants to groups to eliminate bias and better determine differences in outcomes between groups.
Randomized clinical trials are considered the ‘gold standard’ for testing new drugs or treatments, as they provide objective data for researchers.
“[Randomized clinical trials] are critical for comparing different treatment approaches to determine which is superior (or whether they are equivalent),” Dr. Mikhael said. “The concept of randomization reduced the bias in which treatment arm patients are assigned. This ensures a balance of known and unknown factors (age, gender, biological features, etc.) to make sure the comparison is fair by seeking to have each arm of the trial similar.”
According to Dr. Mikhael, this is imperative to the medical research process. “This is a crucial step in the new drug approval process by the FDA to ensure the approved therapies have proven themselves to be both safe and effective,” he said.
While participating in a clinical trial always carries some degree of risk, with the severity depending on the trial phase, they are generally safe. Phase 1 clinical trials typically pose the highest risk, as they aim to identify potential side effects and ensure that the treatment or medication is not toxic to humans.
You should always consult with your doctor before participating in a clinical trial to ensure it is not harmful to your health.
Black patients are historically underrepresented in clinical trials, which impacts how treatments will affect them in the real world. When clinical trials involve a diverse group of participants, researchers can better understand how their treatment works across different racial and ethnic backgrounds and ensure its effectiveness for as many patients as possible.
“Underrepresentation in all clinical trials is a huge problem in medicine and indeed in cancer — it means that these communities have less access to novel therapies that can save and extend lives,” Dr. Mikhael said. “It also means that these new treatments are not as well understood in all patients and that their safety and efficacy in underrepresented groups is not as well known.”
Medical professionals cannot then be sure that the trial results apply to historically underrepresented groups, Dr. Mikhael explained.
“In multiple myeloma, approximately 20 percent of all patients in the U.S. are African American, but representation in clinical trials has typically been only 5-8 percent and often even lower in the larger randomized trials that lead to drug approval,” Dr. Mikhael explained. “We must implement strategies to ensure access to clinical trials for all and address the multitude of reasons for underrepresentation.”
If you and your doctor determine that it is safe for you to participate in a clinical trial, you should expect to complete a preliminary process where you’ll receive details about the study and undergo a health screening. If you meet the study’s requirements, you can enroll.
Your study visits will depend on the specific study and treatment, including how often you go, how long each visit is, and what it entails. Some visits are even conducted virtually. After the study, you will participate in follow-ups to monitor your health and the treatment’s efficacy.
Dr. Mikhael emphasized transparency for all patients, so they have full comprehension of what they are volunteering to do.
“As with all trials, patients should expect an open and honest conversation with their healthcare team to discuss the rationale of the trial, along with potential benefits and risks of the study,” Dr. Mikhael said. “The process of randomization should be explained so patients know what different treatments they may be assigned to, and what their participation means for time in the clinic/hospital, testing, potential costs, and, of course, risks and benefits. They should be provided with an opportunity to answer questions, review the informed consent in detail, and understand their right to withdraw from the trial if they wish.”
While randomized clinical trials are imperative to medical research, all participants must be aware of the trials’ processes, goals, and potential risks before they decide to take part.
“Clinical trials have been a major factor in the improvement of the quantity and quality of lives of patients with cancer and many other diseases,” Dr. Mikhael said. “There has been a terrible history of misconduct in clinical trials, but now so many protections have been introduced to ensure the process is as safe and fair as it can be. Full representation of all groups is a critical part of ensuring access for all and the optimal therapies being developed for all patients.”
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