What is a Clinical Trial? Why should I participate?

25 de marzo de 2020

3 min de lectura

Most people have heard of the term "clinical trial," but aren't really sure what a clinical trial is beyond that you might be given an experimental drug. Especially if you or your loved one has a rare disease, the prospect of a clinical trial opening up can be both exciting and scary. How will you decide if you want to participate? Here we'll go over some background on clinical trials to clean up some of the gray areas.

What is a Clinical Trial?

In the basic sense, a clinical trial is a controlled, highly regulated research experiment involving human volunteers carried out by clinical scientists. Most clinical trials are designed to answer one of two questions: "Does it work?" or "Is it safe?" For the first question, clinical trials could be designed to test a new drug or a new therapy. A new drug is probably the subject most often associated with clinical trials, but simple, benign behavioral therapies also need to be tested, like determining the impact of exercise in cancer survivors.

For answering the "Is it safe?" question, clinical trials are often designed to test different dosages of a drug or intensities of a therapy that has had some success in an earlier study. These types of clinicial trials are usually bigger as well, involving hundreds or thousands of participants. Testing the safety of a treatment can sound scary, because the implication is that some of the dosage or intensity options are too much. Since clinical trials are conducted double-blind, meaning neither the participant or the clinician know who is receiving what, you'll be in the dark for the whole process. But keep in mind, treatments that reach these later stages have been tested extensively in human cells, often animals, and in a few people before reaching this stage. Clinicians already have a good dosage or intensity window to work from before any participants are involved.

Perhaps more importantly, clinical trials are regulated up the wazoo. The regulation starts before any money is handed over to run a clinical trial. The National Institutes of Health, the government agency that funds most clinical trials in the United States, has very strict definitions of a clinical trial and what constitutes research on human subjects so no human participant research falls outside their regulation system. Before any money is awarded for a clinical trial, clinical researchers need to write a small novella's worth of protocol design, regulation, and safety measures that would be put in place if the trial is funded. If the trial is funded, those protocols are scrutinized and rounds of revisions made by Institutional Review Boards (IRBs) where the clinical trials will take place. These include strict measures for when clinical trials should be aborted for participants to ensure their safety and health. So, while clinical trials are designed to find the right dosage or intensity for a treatment and there is some risk involved, every precaution is put in place before any participants are recruited.

Isn't there a chance I'll just get a placebo?

Classically designed clinical trials do require a control group for statistical comparison to decide if the drug or treatment is working. However, many modern clinical trials no longer use placebos, as placebo use has been deemed unethical if it would deny a person a chance to receive a drug that's been known to work for others. This is particularly true for drugs in cancer clinical trials. Before signing up for any clinical trial, the use of a placebo or treatment groups into which you could be assigned is clearly communicated.

Why should I consider participating in a clinical trial?

Participating in a clinical trial means you are contributing to the cutting edge of biomedical research. No one knows the answer to the question being asked, and that answer could not be found without your help! And perhaps more importantly, you'll be helping other people. Every clinical trial teaches us something and collectively brings us one step closer to a cure, even if your clinical trial isn't the "break through" trial. While there are risks involved, every measure is taken to minimize those risks for the participants and ensure their wellbeing. If you'd like to learn more about clinical trials that have been conducted or are about to start, visit ClinicaTrials.gov to explore and view the results of over 330,000 clinical trials in their databank. Clinical trials are how science moves forward. When you or your loved one consider participating, you are helping drive biomedical progress for us and future generations.

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What is a Clinical Trial?

Isn't there a chance I'll just get a placebo?

Why should I consider participating in a clinical trial?

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