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Why should I join a clinical trial?

Clinical trials are an essential part of medical advances, drug development, and disease treatment. The research produced from trials can determine the efficacy of treatment and improve patient care for people with chronic illnesses like Long COVID and Associated Conditions. Whether you’re a healthy volunteer or a patient seeking answers, your participation brings Long COVID community hope for a cure.

Are clinical trials safe?

To protect volunteers, and preserve the integrity of science, certain processes are required for most clinical trials in the US. Ethical guidelines, privacy protections, informed consent, and Institutional Review Board compliance mean the risks of participation are less than potential benefits.

How do I know if I'm eligible to participate?

Each clinical trial listing outlines the eligibility criteria required for participation. Usually, trials reserve opportunities for specifically-affected patients and healthy volunteers. Additional details and considerations can be found through the U.S. National Library of Medicine or by contacting the principal investigator of the study.

What do clinical trial phases mean?

Each clinical trial phase has different objectives, requirements, and outcomes. Phase I trials test a drug or treatment in a small group of people (20–80) for the first time; the purpose is to study a drug or treatment to learn about safety and identify side effects. Phase II trials test a new drug or treatment in a larger group of people (100–300) to determine its effectiveness and to further study its safety. Phase III trials test drugs on large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely. Phase IV trials test a drug or treatment after it has been approved by the FDA and made available to the public; these trials track its safety in the general population, further study the drug or treatment’s benefits, and determine optimal use and clinical guidelines.

What's the difference between interventional and observational studies?

Interventional studies assign participants to groups that will receive a treatment intervention or serve as a control group not treated. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational studies track participants who may receive diagnostic, therapeutic, or other types of interventions, but are not assigned to a specific interventions or treatments. These studies observe participants for specific outcomes without mediating change, like a patient registry. 

Expanded access studies, also called compassionate use, are available for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the FDA. Also called compassionate use.

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