Thinking About Participating in a Clinical Study?

Sept. 3, 2024

Here’s Everything You Need to Know:

What Is a Clinical Study?

A clinical study is a privately or publicly funded research project in which new medical approaches are tested on voluntary participants. These studies aim to find better ways to prevent, diagnose, and treat health conditions.

What Are the Different Types of Clinical Studies?

There are two main types of clinical studies—clinical trials and observational studies.

Clinical Trials: These studies evaluate the effectiveness and safety of medical devices, diagnostic procedures, and medications. Participants are assigned specific interventions to test their impact on health outcomes.
Observational Studies: These studies collect biospecimens or data on health outcomes without assigning specific interventions to participants. They observe the natural progression of diseases and the effects of various treatments in real-world settings.

Where Can I Join a Clinical Study?

Consult your doctor to determine if participating in a clinical study could be suitable for you. They will review your medical history, conduct a physical examination, and assess your overall health to help decide if you are an ideal candidate for a clinical study.

What Are the Benefits of Community-Based Clinical Studies?

A clinical study provides an additional option for patients beyond standard treatments. While standard treatments are widely used and agreed upon by professionals, clinical studies explore new methods that may offer more effective or safer alternatives. Benefits of participating in a clinical study include:

Access to cutting-edge treatments not yet available to the public.
Contributing to medical research that may benefit future patients.
Receiving close monitoring and additional care from the clinical research team.

What Are the Phases of a Clinical Study?

Clinical studies consist of four phases, each with a specific purpose. Participants typically engage in only one phase, but each phase is crucial to the research process.

Phase I: Tests the safety and best method of administration of a new treatment. It involves a small group of 20-100 participants and lasts several weeks to months.
Phase II: Assesses the treatment’s effectiveness and side effects in 100-300 participants over several months to a year.
Phase III: Compares the new treatment to standard treatments in 500-5,000 participants over several years. This phase determines if the new treatment offers additional benefits and is submitted for regulatory approval.
Phase IV: Monitors the treatment's long-term effects and overall benefits after it is approved and made available to the public. It involves more than 1,000 participants and lasts several years.

How Does a Clinical Study Compare to Standard Treatment Options?

Clinical studies test new treatments to compare their effectiveness with standard treatments. Standard treatments are widely used and agreed upon by professionals, while clinical studies aim to find more efficient ways to treat conditions.

Addressing the Stigma Around Clinical Trials

There is often a stigma surrounding clinical trials, with misconceptions about safety and effectiveness. It is important to understand that clinical trials follow rigorous protocols to ensure participant safety and gather reliable data. Participating in a clinical trial does not mean you are a "guinea pig." Instead, you are contributing to advancements in medical science and potentially benefiting from new treatments. Understanding these aspects can help reduce any stigma and make you feel more comfortable considering clinical trials as a viable treatment option.

How Will My Privacy Be Protected?

Your privacy is protected through strict adherence to HIPAA regulations, informed consent, data coding, and secure storage practices. These measures ensure your sensitive information remains confidential throughout the study.

Will I Receive Any Compensation or Reimbursement for My Participation?

Compensation or reimbursement varies depending on the study. Some studies offer payment, especially in the earlier phases, while others may not.

What Happens If the Study Treatment Does Not Work for Me or I Change My Mind and Want to Withdraw?

If the treatment does not work for you, your doctor will discontinue your participation and explore alternative treatment options. You can withdraw from the study at any time without facing any penalties.

Talk to your provider to see if you are an eligible candidate for a clinical study near you.