About Clinical Trials

Participant Selection and Informed Consent — Clinical trials recruit participants based on specific criteria, such as age, gender, medical history, and the stage of the disease. Potential participants must provide informed consent, meaning they fully understand the trial’s purpose, potential risks, benefits, and procedures before deciding to join.

Randomization and Control Groups — Many clinical trials use randomization to assign participants to different groups. The experimental group receives the new treatment, while the control group may receive a placebo or the standard treatment. This helps researchers determine if the new treatment is more effective or safer compared to existing options.

Data Collection and Analysis — Throughout the trial, researchers collect data on participants’ health, treatment response, and potential side effects. This data is rigorously analyzed to determine the treatment’s efficacy, safety profile, and any statistically significant differences between the experimental and control groups.

Ethical Considerations — Clinical trials adhere to ethical standards and are typically overseen by Institutional Review Boards (IRBs) or Ethics Committees. These bodies ensure the protection of participants’ rights, safety, and well-being throughout the trial.

Publication and Regulatory Approval — After the trial’s completion, the results are typically published in medical journals to contribute to the scientific community’s knowledge. Positive results from phase 3 trials can lead to regulatory authorities (such as the FDA in the United States) granting approval for the new treatment to be marketed and used for patient care.

Phases of Clinical Trials

Phase 1 — These trials involve a small number of healthy volunteers or individuals with the specific condition targeted by the treatment. The primary goal is to assess the treatment’s safety, dosage levels, and potential side effects.

Phase 2 — In this phase, a larger group of participants, often patients with the target condition, receive the treatment to evaluate its efficacy and further assess safety. Researchers also gather preliminary data on its effectiveness.

Phase 3 — This phase involves a larger and more diverse group of participants to confirm the treatment’s effectiveness, monitor side effects, and compare it with existing standard treatments or a placebo.

Phase 4 — Also known as post-marketing surveillance trials, these studies occur after a treatment has been approved and is on the market. They continue to monitor the treatment’s long-term safety and effectiveness in real-world settings.

Medical Condition — If you have a medical condition that the clinical trial is targeting, participating could offer access to potentially innovative treatments that may not be available through standard care. Additionally, the stage of your disease or condition may impact your eligibility for certain trials. Some trials may be specifically designed for early-stage cases, while others target advanced stages.

Treatment Options — Consider the available treatment options for your condition. If standard treatments have not been effective or are associated with significant side effects, a clinical trial might offer an alternative worth considering.

Potential Benefits — Understand the potential benefits of the experimental treatment. This could include the possibility of receiving a more effective treatment, improved quality of life, or access to treatments not yet available to the general public.

Risks and Side Effects — Be fully aware of the potential risks and side effects associated with the experimental treatment. Discuss these thoroughly with the trial’s researchers and your healthcare provider.

Trial Design — Understand the trial’s design, including whether it involves randomization, blinding, and the use of control groups. Clinical trials can span weeks, months, or even years. Assess whether you’re willing and able to commit to the trial’s timeline and requirements. These factors can affect your experience during the trial. Additionally, you should ensure that you will receive regular updates and information about your progress in the trial and the trial’s overall results.

Credibility — Research the trial thoroughly. Look into the research team’s credentials, the trial’s reputation, and any previous studies they have conducted. Government agencies and reputable medical institutions are good sources of information about ongoing trials.

Impact on Daily Living — Consider how participating in a clinical trial might affect your daily life, such as time commitments for appointments, potential travel requirements, and any financial costs not covered by the trial.

Webinar: Understanding Clinical Research

In this webinar, the Autoimmune Association and partners Immunovant and CISCRP, present a discussion about the important role clinical research plays in advancing care for people with autoimmune disease. Moderated by an expert in medical research, the webinar addresses the various types of clinical research, the important role that volunteers play in the research process, the benefits and risks of clinical trial participation, and how to navigate the clinical trial process. View

Panel Discussions: Clinical Trials & Autoimmune Disease

Recorded panel discussion from the 2023 Autoimmune Community Summit.
Clinical trials play a pivotal role in evaluating new therapies, investigating potential cures, and improving the lives of people living with autoimmune disease. This panel will break down the complexities of clinical trials and provide tools and tips to help determine if a clinical trial is right for you. View

Recorded panel discussion from the 2022 Autoimmune Community Summit.
Clinical trials are the lifeblood of medical innovation – without them, we wouldn’t have the incredible treatments that exist for autoimmune diseases on the market today. How do clinical trials work? How can you learn more and enroll in clinical trials to get access to the most cutting-edge options? What are the perceived barriers to trials and how do we break down those barriers? Join us for this panel to learn from experts and hear firsthand from patients that have participated in clinical trials. View

The Center for Information and Study on Clinical Research Participation (CISCRP) Resource Library

The Center for Information and Study on Clinical Research Participation (CISCRP) offers an extensive library of resources to help you understand clinical trials and what it means to be a participant. View

The U.S. Department of Health and Human Services Resources Library

The U.S. Department of Health and Human Services offers resources for the public to learn about participating in research and making informed decisions. View