Introduction

Clinical trials are vital for potentially advancing medical research and developing treatments for a wide range of conditions. Every medication, therapy, and medical device available today has gone through rigorous clinical testing to assess its safety and effectiveness. From an over-the-counter pain reliever to a prescribed medical device used for managing a chronic illness, all treatments must undergo a clinical trial before being approved for public use.

With so much misinformation surrounding clinical trials, it’s easy to feel uncertain about whether they’re a viable option. Let’s clarify the facts by debunking five of the most common clinical trial myths.

Myth #1 – Participants are just a number for researchers

The truth is clinical trials are highly regulated and follow strict protocols and clinical research ethics guidelines to protect patient safety. Patient well-being is prioritized throughout the trial process and is accounted for in the clinical trial protocol. Data collection is important to see if a new treatment is effective, but protocols are written to ensure that patient safety is top of mind.

Before the process begins, the potential participant undergoes the informed consent process, where a clinical trial professional educates them about the risks, benefits, and their rights during the clinical trial ncbi.nlm.nih.gov.

Myth #2 – If I join a clinical trial, I will get a placebo instead of the real treatment

A placebo is an inactive pill-like substance that resembles the “real” treatment but does not provide any harm or benefit. For example, in a clinical trial that utilizes placebos, the participants may be divided into two groups. One group may receive a placebo while the other receives the investigational medication. The placebo is used as a control variable to study the investigational medication offered, compared to standard treatment.

However, in clinical trials where a placebo is utilized, the clinical trial staff may not know which participants are being administered the placebo or the investigational treatment. This is known as a double-blind study. In other cases, placebos may not replace the standard treatment while participating in clinical trials. The standard treatment is the widely accepted and FDA-approved treatment that is used for a specific condition. In cases where a standard treatment exists, patients may receive either the FDA-approved treatment coupled with the placebo or an investigational treatment, especially in life-altering conditions.

Not every clinical trial utilizes placebos. Some clinical trials may test different dosages of the FDA-approved treatment to determine the most effective and safest amount for patients. Others may compare multiple existing treatments to evaluate which one works best or has fewer side effects. Additionally, some studies focus on lifestyle changes, such as diet or exercise, in conjunction with standard medical treatments to assess their impact on overall health outcomes.

Myth #3 – Clinical trials do not follow guidelines

Though clinical trials are researching investigational treatments, they follow strict safety protocols, safety monitoring and undergo multiple testing phases [link to blog discussing phases]. Many trial sponsors will implement a data safety monitoring board (DSMB) as added protection for patients while ensuring the results of the trial are still being met.

Although clinical trial risks are still applicable, just like any medication, strict guidelines and regulations are in place to keep patients protected. Potential participants are fully informed of all risks, benefits, and procedures before giving their consent, and they have the right to request withdrawal at any time. Regulatory authorities oversee every phase of the process to ensure compliance with safety standards. Clinical trial medical professionals also oversee participants throughout the study, carefully tracking their health and addressing any concerns. While these studies explore investigational treatments, every step is designed to prioritize patient safety and minimize potential risks.

Myth #4 – Clinical trial medications have worse side effects than standard treatments

Some trials involve low-risk investigational treatments, such as non-invasive procedures or well-studied medications, while others test investigational therapies as a new option to treat an underlying condition.

Regular check-ins, lab tests, and medical evaluations help doctors closely monitor participants and address any side effects. Clinical trials also have built-in safety measures, including guidelines to pause or adjust the study if unexpected concerns arise.

Myth #5 – Clinical trials are only for sick people

Trials need diverse participants, including different ages, backgrounds, and health conditions, to determine whether the treatment works for everyone. Many trials actively seek older adults and people with chronic conditions.

Early-phase clinical trials also recruit healthy participants. These clinical trials are implemented to gather knowledge and observations and help establish safety information to be utilized in the latter phases of the trial, but the participant is healthy, so they do not need treatment for a certain condition. Many people who take part in these trials do so because they have an interest in contributing to the potential advancement of medical research.

Clinical trials often have age restrictions in place, which can vary depending on the study’s focus and the specific investigational treatment being tested. Age limits verify the safety, efficacy, and appropriateness of the investigational treatment for the target population. These restrictions are determined based on factors such as how a drug is metabolized at different life stages, potential risks to younger or older individuals, and the ethical responsibility to protect vulnerable populations. In pediatric trials1, for example, additional safeguards help evaluate whether treatments are suitable for children’s developing bodies, while geriatric trials2 consider age-related changes in metabolism, organ function, and comorbidities.

Sources:

1. Should Your Child Participate in a Clinical Trial? | FDA
2. Elderly patients’ participation in clinical trials – PMC

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Conclusion

Clinical trials are a critical part of advancing medical research. While myths and misconceptions can create hesitation, the reality is that clinical trials are highly regulated, prioritize patient safety, while providing participants with valuable medical oversight. Whether you’re looking for alternatives or simply want to contribute to future medical advancements, understanding the facts can help you make an informed decision about participation.