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Why Clinical Trials Are Important for Thyroid Eye Disease

Written by Torrey Kim
Posted on December 2, 2024

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Thyroid eye disease (TED) can be difficult to control, and it may affect your quality of life.1,2 Living with TED can affect your vision, cause pain and discomfort, change your appearance, and even lead to anxiety and mood swings.2 Fortunately, researchers are evaluating new treatments for TED in clinical trials, which could help people with TED in the future.

Thyroid eye disease, also called Graves orbitopathy, is an autoimmune disease that causes inflammation in the eyelids, eye muscles, tear glands, and tissues on the back side of your eye.1,2 This causes the eyes to become swollen and red, and potentially to protrude forward in a bulging position, among other TED symptoms.2

Find Out If You Qualify For A TED Clinical Trial

What Are Clinical Trials?

Clinical trials are studies that test investigational new drugs or medical interventions. Clinical trials might also involve lifestyle interventions, such as a specific diet, or a new procedure, or medical device. Before a drug is ever tested in humans, researchers study the drug in a laboratory setting.4 If deemed to be safe, it is moved to a clinical trial.

In a clinical trial, scientists first test the investigational study drug on a small group of volunteers to understand whether it is safe. If the drug is found to be safe, scientists will do more tests with bigger groups to find out how well the drug works and if it's better than what's already available.4

If you join a clinical trial, your rights and safety are a top priority. In the United States, government agencies like the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have guidelines and policies to ensure the clinical studies are safe, ethical, and of high quality.5,6

Clinical trials are particularly important for less common conditions because many of these conditions have few, or no, treatment options. There are no treatments approved for more than 95 percent of rare diseases.9

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There’s no guarantee that a clinical trial will lead to an effective new medication.7 However, what’s learned in a study can help researchers understand the disease better and investigate treatment options for people with TED or other diseases.4

You can learn about clinical trials for TED from your ophthalmologist or endocrinologist. You can also visit sites like ClinicalTrials.gov to learn about trials you might qualify for.8

Clinical Trials and Less Common Diseases

Every investigational study drug for thyroid eye disease — or any other condition — must be tested before it can be approved by the FDA. New treatments couldn’t be approved without people who volunteer to help advance research.4

Clinical trials are particularly important for less common conditions because many of these conditions have few, or no, treatment options. There are no treatments approved for more than 95 percent of rare diseases.9 Although not technically a rare disease, TED is uncommon and only one treatment has been approved by the FDA to treat this condition.10,11

Many factors can make it difficult for researchers to study uncommon or rare diseases. One of the challenges is that there are fewer people who could participate in a clinical trial, and they may live far away from where trials are being conducted.12

Researchers are currently investigating other thyroid eye disease treatments through clinical trials. Individuals who volunteer to join the trials are important for helping them to understand if new therapies can help people with TED.3

Find Out If You Qualify For A TED Clinical Trial

Considerations for Joining a Clinical Trial

There are many reasons you might consider participating in clinical research for thyroid eye disease.

Below are some factors to consider:

  • You may have access to investigational study drugs that aren’t yet available publicly. It’s also possible that you will receive a placebo.4
  • You may experience side effects from the investigational study drug.4
  • The investigational study drug is not yet FDA-approved.4
  • You may not have to pay for the study medication, and you may receive a stipend for study visits.3
  • Reasonable reimbursement for ground travel (such as rideshare services) and study-related expenses may be provided.3
  • Enrollment in clinical trials is completely voluntary. You may withdraw at any time.4

Talk to your health care provider if you’re interested in participating in a research study for thyroid eye disease. They can help you understand the risks and potential reasons to consider joining.4

References
  1. Your guide to thyroid eye disease. British Thyroid Foundation. 2008. Updated 2021. Accessed April 17, 2024. https://www.btf-thyroid.org/thyroid-eye-disease-leaflet
  2. Thyroid eye disease (Graves’ disease). Penn Medicine. Accessed April 17, 2024. https://www.pennmedicine.org/for-patients-and-visitors/find-a-program-or-service/ophthalmology/thyroid-eye-disease-graves-disease
  3. Envision the potential of TED research. Patient brochure. Tourmaline. August 30, 2023.
  4. NIH clinical research trials and you: the basics. National Institutes of Health. Updated October 3, 2022. Accessed April 17, 2024. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
  5. NIH and other federal guidelines & policies for clinical research. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Updated October 2022. Accessed April 17, 2024. https://www.niams.nih.gov/grants-funding/conducting-clinical-research/trial-policies-guidelines-templates/nih-federal-guidelines
  6. Regulations: good clinical practice and clinical trials. U.S. Food and Drug Administration. Updated January 21, 2021. Accessed April 17, 2024. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
  7. Types and phases of clinical trials. American Cancer Society. Updated August 18, 2020. Accessed April 17, 2024. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
  8. Home. ClinicalTrials.gov. Accessed April 17, 2024. https://clinicaltrials.gov/
  9. Information on clinical trials and research studies. National Organization for Rare Disorders. Accessed April 17, 2024. https://rarediseases.org/living-with-a-rare-disease/clinical-trials/
  10. Thyroid eye disease. National Organization for Rare Disorders. 2020. Updated March 21, 2024. Accessed April 17, 2024. https://rarediseases.org/rare-diseases/thyroid-eye-disease/
  11. FDA approves first treatment for thyroid eye disease. U.S. Food and Drug Administration. January 21, 2020. Accessed April 17, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease
  12. Mellerio, JE. The challenges of clinical trials in rare diseases. Br J Dermatol. 2022;187(4):453-454. doi:10.1111/bjd.21686

Torrey Kim is a freelance writer with MyHealthTeam. Learn more about her here.
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