Clinical trials are research studies involving volunteers that help scientists explore and create new methods to prevent, diagnose, or treat diseases and their symptoms. These studies may test investigational treatments such as new medications, combinations of drugs, innovative delivery methods for existing drugs, or medical devices. Before approval, new treatments undergo extensive testing, beginning in the laboratory, progressing to animal studies, and finally being evaluated in humans. To gain approval, a new medication or device must prove its safety and effectiveness, and in many cases, show greater benefits compared to existing products on the market.

Clinical trials for investigational products, such as medications, devices, or procedures, are conducted in distinct phases to gather specific information about their safety, effectiveness, and potential applications. Phase 1 Studies Phase 1 trials involve a small group of participants (20-80), often healthy volunteers or patients with advanced diseases like cancer or mental health disorders. This is typically the first stage of human testing for a product. The primary objectives of Phase 1 are to: Assess safety Identify potential side effects Determine safe dosage ranges Understand how the body processes the product (pharmacokinetics and dynamics) These studies usually take several months, and about 70% of Phase 1 trials advance to Phase 2. Phase 2 Studies Phase 2 trials enroll a larger group (100-300 participants) with the specific condition being studied. These trials further evaluate safety and test whether the product achieves its intended effect in humans. Often randomized controlled trials May compare the investigational product with a placebo or standard treatment Frequently “blinded,” so neither participants nor researchers know who receives the active product Phase 2 studies typically last up to two years, with approximately 33% progressing to Phase 3. Phase 3 Studies Phase 3 trials involve thousands of participants with the disease or condition. These studies aim to: Confirm or further evaluate effectiveness Monitor side effects on a larger scale Compare the product with existing treatments Gather data needed for regulatory approval and marketing These randomized and blinded trials can take one to four years to complete. Around 25-30% of Phase 3 trials are successfully completed and submitted to the FDA for review and potential approval. Phase 4 Studies Also known as Post-Marketing Surveillance Trials, Phase 4 studies are conducted after FDA approval. They focus on: Collecting long-term data on risks and benefits Assessing the product's performance across diverse populations Monitoring for rare or delayed side effects Findings from Phase 4 studies can lead to changes in usage guidelines or even market withdrawal if significant safety concerns arise. Each phase of clinical trials plays a critical role in ensuring that investigational products are safe, effective, and ready for public use.

Participating in a clinical trial offers the chance to explore a new treatment, which may or may not prove more effective than existing options. As a participant, you contribute to a deeper understanding of how treatments work across diverse populations, as responses can vary by race, gender, and other factors. Regulatory agencies like the FDA emphasize the importance of including people of different ages, races, ethnicities, and genders in clinical trials to ensure broad representation. Why Consider Joining a Clinical Trial? Early access to new treatments not yet available to the public Free access to study-related medications Potential compensation for participation in some studies Personal fulfillment from advancing medical research Voluntary participation—you can withdraw at any time Each clinical trial has specific eligibility requirements that participants must meet. Not everyone who applies will qualify, but those who do play a vital role in advancing healthcare and science.

There are various types of clinical research studies, each designed to address specific health challenges, such as: Prevention Studies: Focused on discovering ways to prevent diseases in those who have never had them or to stop them from returning. Approaches may include medications, vaccines, vitamins, minerals, or lifestyle changes. Treatment Studies: Evaluate new therapies, drug combinations, or innovative approaches to treating diseases. Diagnostic Studies: Aim to develop improved tests or procedures for identifying specific diseases or conditions. Screening Studies: Explore the most effective methods for detecting diseases or health conditions early. Quality of Life (Supportive Care) Studies: Investigate ways to enhance comfort and overall well-being for individuals living with chronic illnesses. Typically, clinical trials compare a new product or treatment with an existing one to determine if it is equally effective or better at treating or preventing a disease. In blinded studies, participants are randomly assigned to receive either the investigational product or an approved therapy without knowing which they are receiving. Some studies also involve a placebo, a substance that resembles the test product but has no therapeutic effect. Comparing a treatment to a placebo is often the most efficient way to demonstrate its effectiveness. Before joining a trial, participants are fully informed about the study's details, including whether a placebo will be used, the potential risks, and the possible benefits of the investigational treatments.

A clinical research study follows a structured research plan called a study protocol, created to address specific research questions and ensure participant safety. The protocol outlines key details, including: The purpose of the study Criteria for participant eligibility (inclusion and exclusion requirements) The number of participants required The schedule for tests, procedures, investigational treatments, and dosages The duration of the study The type of data to be collected about participants This protocol serves as a detailed guide for conducting the study and maintaining its scientific and ethical integrity.

The clinical research team is committed to maintaining the strict confidentiality of your Personal Health Information (PHI). Your information will only be shared with your consent or when required by law. If you choose to provide your information through this website, and with your permission, it will be securely entered into our clinical research database for consideration in current and future study opportunities. You may request to have your information removed from the database at any time. Similarly, if you call and speak with one of our research specialists, your information will be securely added to the same database. Participation is entirely voluntary, and you can ask to have your information deleted at any time.