About Us
What is a Clinical Trial?
Purpose of Clinical Trials
Clinical trials aim to answer scientific questions and find better ways to prevent, diagnose, or treat diseases. They can also show researchers what does not work, which is as important for advancing medicine. Participants in clinical trials can potentially gain access to new treatments before they are widely available and help others by contributing to medical research.
Phases of Clinical Trials
Clinical trials are conducted in phases, each designed to answer a separate research question:
- Phase I: Tests the safety of a new treatment, determines a safe dosage range, and identifies side effects.
- Phase II: Focuses on effectiveness and further evaluates safety.
- Phase III: Confirms effectiveness, monitors side effects, compares it to commonly used treatments, and collects information that will allow the treatment to be used safely.
- Phase IV: Occurs after FDA approval and aims to gather more information on the treatment’s risks, benefits, and optimal use in diverse populations.
Participation in Clinical Trials
Participating in a clinical trial is a significant decision that involves potential risks and benefits. Informed consent is a vital part of the process, ensuring participants are well aware of the risks, benefits, and details of the study. Volunteers in clinical trials can include people with specific health conditions as well as healthy participants depending on the study’s requirements.
By participating in clinical trials, individuals not only contribute to the understanding of diseases but also assist in the development of newer, safer, and more effective medical approaches.
Why They Matter
Clinical trials are crucial because they contribute to advances in science and health care that lead to better therapeutic options, preventive measures, and diagnostic tools. They are vital for pushing medical care forward and ensuring continued improvement in the quality and outcomes of health care across populations.
Participating in a Trial
What Should I Expect?
Participating in a clinical trial is an important decision that contributes significantly to medical research and can potentially offer access to the latest medical interventions. Understanding what to expect during the trial can help you make an informed decision. Here’s a step-by-step guide through the typical clinical trial process:
Pre-screening & Informed Consent
Before participating, you will undergo a pre-screening process to determine if you meet the trial's eligibility criteria. If you qualify, the study team will provide detailed information about the trial, including its purpose, duration, required procedures, potential risks and benefits, and your rights as a participant. You will have the opportunity to ask questions before giving your informed consent.
Enrollment
Once you consent to participate, you will be officially enrolled in the trial. The study team will collect baseline health information and may conduct initial tests or assessments.
Intervention & Monitoring
Depending on the trial phase and purpose, you may receive a new treatment, a placebo, or standard therapy. Throughout the trial, your health will be closely monitored to assess the effectiveness of the treatment and to ensure your safety. This monitoring can include regular health checks, medical tests, or tracking of symptoms.
Follow-up
After the active phase of the trial, there may be a follow-up period where the study team continues to monitor your health to assess the long-term effects and outcomes of the treatment.
Completion
Once the study is completed, you will typically be informed about the results of the trial and any further steps that may need to be taken. Depending on the trial, participants may continue receiving the study treatment or may be directed to other treatment options.
Support Throughout the Trial
Throughout the trial, you will have access to a dedicated team of medical professionals. This team is available to answer any questions you have and provide support. Your participation is voluntary, and you have the right to withdraw from the trial at any time, for any reason, without affecting your standard care.
Safety and Ethics
Clinical trials are conducted under strict ethical and legal codes to ensure participant safety. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are as low as possible and are worth any potential benefits.
Why Your Participation Matters
By participating in a clinical trial, you play a vital role in helping to advance medical knowledge and improve health care for everyone. Your involvement can lead to the development of new treatments that might save lives or improve the quality of life for people with various health conditions.
Types of Trials
Types of Clinical Trials Offered
- Drug Trials
- Purpose: To test new pharmaceutical compounds for efficacy and safety in treating various diseases.
- Example: A phase III trial testing a new targeted therapy for advanced melanoma.
- Device Trials
- Purpose: To evaluate new medical devices, such as implants or wearable technology, for safety and functionality.
- Example: Testing a new type of continuous glucose monitor for patients with type 1 diabetes.
- Preventive Trials
- Purpose: To find better ways to prevent diseases in people who have never had the disease or to prevent a disease from returning.
- Example: Testing a new vaccine to prevent Lyme disease.
- Diagnostic Trials
- Purpose: To find better tests or procedures for diagnosing a particular disease or condition.
- Example: Evaluating the effectiveness of a new imaging technology for early detection of pancreatic cancer.
- Screening Trials
- Purpose: To test the best way to detect certain diseases or health conditions.
- Example: A study to determine the best method to detect early-stage colorectal cancer in populations at risk.
- Treatment Trials
- Purpose: To test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Example: A trial comparing the effectiveness of robotic surgery versus traditional surgery for the treatment of prostate cancer.
- Behavioral Trials
- Purpose: To test interventions designed to modify human behaviors associated with health risks.
- Example: A study evaluating the impact of a mobile app-based therapy on medication adherence in patients with chronic diseases.
- Quality of Life Trials (Supportive Care)
- Purpose: To explore ways to improve comfort and quality of life for individuals with a chronic illness.
- Example: Assessing the effectiveness of acupuncture in reducing chemotherapy-induced nausea in cancer patients.
- Genetic Studies
- Purpose: To improve disease prediction and treatment by studying how genes and illnesses are related.
- Example: A trial to identify genetic markers linked to increased risk of developing Alzheimer’s disease.
- Combination Trials
- Purpose: To test treatments combining drugs, new surgeries, and other therapies.
- Example: A study investigating the combined effect of immunotherapy and radiation on lung cancer survival rates.