In 1938, the U.S. Food, Drug, and Cosmetic Act set the standards for clinical trials and how medications and treatments are evaluated and released to the public. Clinical trials have continued to grow and offer new opportunities for medical advancement. Even over-the-counter medicines, like ibuprofen, exist today because of clinical trials! However, we would be remiss to think there weren’t some hesitations and misconceptions surrounding clinical trials. These clinical trials can offer life-saving treatments for those who may not have other options. Without volunteers, like you, it wouldn’t be possible for those treatments to be released to the public! Let’s sit down and bust some myths about clinical trials.
You are NOT a Guinea Pig
The FDA and sites that conduct clinical trials have your safety at the top of their minds at all times. Before human trials begin, the FDA requires that investigational treatment must be submitted for review. This includes all data from non-human testing, guidelines for how the study should be conducted, and information on why the treatment is necessary. Once the FDA approves for further research, human trials can begin. Although research has been completed and the FDA has given approval, there is no way to tell whether an investigational treatment is safe for the human body without additional research. Every human being’s body works and processes things differently, so there is some risk involved. Because of this, each clinical trial has what is called an informed consent that is reviewed with each patient. This document discusses the purpose of the study, the volunteer requirements, any side effects experiences thus far, visit schedule, treatment information, and compensation if applicable.
After reviewing the information, if you agree to continue with the study, you will sign it. If you do not agree to sign it and participate in the study, you can simply be on your way. Even if you do sign, the clinical trial process is completely voluntary. Even if you agree to participate in the beginning, you can withdrawal at any time. You have the power 100% of the time.
ALL Types of Volunteers Needed
There are two types of volunteers needed for clinical studies: healthy volunteers and volunteers who have the condition that is being researched. Additionally, every race, sex, and gender are needed.
- Healthy Volunteers– Help establish how the treatment interacts with a healthy body. Healthy volunteers help build the foundation of effectiveness, safety, dosing, and delivery methods.
- Volunteers with the Condition– If a clinical trial is investigating a new medication for a condition, eventually, the trial will need volunteers with the actual condition to verify how well it performs.
Participation Benefits
Clinical trials help advance treatment options for future generations. One of the benefits of participating is that you are personally helping to ensure treatment options for EVERYONE in the future. Here are a few others:
- Study-Related Care– Receive regular monitoring by a team of medical professionals. For those without insurance, clinical trials are a great option to get under the care of a medical professional at no cost.
- Access to New Treatments– These treatments may work better than current ones.
- Compensation– Many studies offer reimbursements for time and travel.
MyLocalStudy and Clinical Trials
So, only you can answer the question if clinical trials are right for you. Not all trials involve medications. Some are a single blood draw, and some may be observational so that you can participate at your level of comfort.
MyLocalStudy is a website where volunteers like you can have a single place to view enrolling studies of all types in your area. You can read more about the study, and even apply directly from our website. To see what is available in your area visits us HERE.
References:
https://accelresearchsites.com/clinical-trials-need-healthy-volunteers/
https://catalyst.phrma.org/debunking-common-myths-about-clinical-trials
https://www.nia.nih.gov/health/infographics/clinical-research-right-me
