This Clinical Trial Guide article explains qualifications for clinical trials & answers the question: Do I qualify for a clinical trial? It is important to be aware of the eligibility criteria of a specific trial before looking further into a study for your condition, as they are the ultimate deciding factors as to whether or not a volunteer or participant would be able to join a trial.
It can already feel overwhelming to learn about clinical trials, so finding out if you are eligible ahead of time can guide you to a better fit faster by helping you to be more confident while researching a trial that tailors to you.
Why Does Eligibility Matter?
The reason that clinical trials require eligibility criteria is because there are substantial dissimilarities among patients even if they possess the same disease or condition. These differences can alter the results in a clinical study and make it more difficult to determine if a new drug or treatment is working to the best of its ability in targeting the main pathogen or deficiency in the body. Therefore, when a clinical trial is utilizing a controlled study group by recruiting individuals that are more alike in fundamental aspects, the research team can be more certain that results occur from the treatment and not from outside influences, such as dissimilar genetics and conditional backgrounds.
Finding out if you are eligible does require some steps, as the research team involved goes through a rigorous screening process when looking for candidates. Eligibility depends heavily on the specific trial’s study protocol, and just because you may not fit one trial, that does not mean there are none out there that you may qualify for. Some of the many inclusion or exclusion criteria may include factors such as:
- Stage or severity of the disease or condition
- If you are undergoing current treatment
- If you are currently taking medications
- If you have had any previous treatments
- Possessing medical conditions apart from the one being studied
These factors must satisfy the needs of the specific trial you are considering. Keep in mind that even before you investigate to find out if you are eligible, there may be additional screening needed after the informed consent process to make sure that everything is in line with the protocol of the trial.
What Kinds of Testing and Procedures Will I Go Through?
No matter the clinical trial study, there will always be testing and procedures involved. There are laws and regulations put in place to ensure that all participants are informed and fully aware of what they can expect prior to joining a trial. With that being said, the types of testing and procedures you may experience can only be determined by the type of clinical study you are participating in.
Many clinical trials are generally testing a new drug or medical device, but those are not the only kind of treatments out there that are in practice. According to the FDA, “a treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy” (Inside Clinical Trials: Testing Medical Products in People). These various treatments will all depend on the type of study pertaining to a specific disease or condition that researchers are wanting to better understand and learn how to treat. Clinical trials have aided in the advancement of medicine and medical practice, and the study of new treatments will only help propel scientific discovery through its process.
At Clinical Trial Guide, we have a team of subject matter experts to help address some critical questions you may have, as our goal is to help you be mentally prepared as to what encounters you may experience going into a clinical study yourself. We cannot stress enough, however, that it is important to ask questions pertaining to your specific needs and concerns to your doctor and clinical research team before or as they arise in your clinical trial.
Center for Drug Evaluation and Research. “Inside Clinical Trials: Testing Medical Products in People.” U.S. Food and Drug Administration, FDA, 6 Nov. 2014, www.fda.gov/drugs/information-consumers-and-patients-drugs/inside-clinical-trials-testing-medical-products-people.
NIH National Institute on Aging (NIA). “Clinical Trials: Benefits, Risks, and Safety.” National Institute on Aging, U.S. Department of Health and Human Services, 17 May 2017, www.nia.nih.gov/health/clinical-trials-benefits-risks-and-safety.
Office of the Commissioner. “Step 3: Clinical Research.” U.S. Food and Drug Administration, FDA, 26 Jan. 2018, www.fda.gov/patients/drug-development-process/step-3-clinical-research.
Office of the Commissioner. “What Patients Need to Know About Institutional Review Boards.” U.S. Food and Drug Administration, FDA, 26 Jan. 2018, www.fda.gov/patients/clinical-trials-what-patients-need-know/what-patients-need-know-about-institutional-review-boards.
Pharmaceutical Research and Manufacturers of America (PhRMA). Biopharmaceutical Research & Development: The Process Behind New Medicines. 2015. http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf.
“Scientific Review in Cancer Clinical Trials.” Cancer.gov, US National Cancer Institute, 13 Feb. 2020, www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/scientific-review.
The American Cancer Society medical and editorial content team. “Types and Phases of Clinical Trials: What Are Clinical Trial Phases?” Cancer.org, American Cancer Society, Inc., 18 Aug. 2020, www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what- you-need-to-know/phases-of-clinical-trials.html.
“The Basics.” National Institutes of Health, U.S. Department of Health and Human Services, 20 Oct. 2017, www.nih.gov/health-information/nih-clinical-research-trials-you/basics.
“What Are Eligibility Criteria and Can Anyone Participate in Clinical Trials?” Clinical Trials and Me, 2018, www.clinicaltrialsandme.com/resources/what-are-eligibility-criteria-clinical-trials.html.
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