What is a clinical trial?
A clinical trial is a research study to determine whether a new drug, treatment, combination of drugs, medical device or procedure is safe and effective. A clinical trial involves patients who volunteer to help doctors and researchers find better ways to prevent, treat or diagnose diseases. There are several types of clinical trials, some test new ways to treat the disease, while others test new methods of prevention or detection of a disease.
Clinical trials are designed to answer specific questions about:
- Safety
- Benefits
- Side effects
- Evaluation of ways in which genetics may be related to an illness
What are the types of clinical trials?
- Treatment Trials - Test new or different approaches to treatment
- Prevention Trials - Focus on preventing a disease or stopping a disease from returning
- Screening Studies -Test to find the best ways to detect a disease or condition
- Quality of Life Studies - Evaluate the effects of treatments on comfort and quality of life
- Post Surveillance Studies - Follows the effects of an approved therapy after widespread use
Who can participate in a clinical trial?
Before joining a clinical trial, the volunteer must meet certain criteria. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone to participate in a clinical trial are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. This inclusion and exclusion criteria are used to identify appropriate participants, promote safety, and ensure that researchers learn the information specific to the study.
Qualified participants will receive all study-related care at no charge, including physician examinations, laboratory services, imaging services and study related medications.
What kinds of trials does Riverside Health conduct?
Riverside Health currently is conducting clinical trials and clinical studies in:
- Cardiology
- Neurology
- Oncology
Why should I participate in a clinical trial?
Participation in clinical trials is a decision that needs to be discussed with the participant's loved ones/support system and their physician. Participants in clinical trials play a key role in drug development and discovery.
There are various reasons to participate in clinical trials. Some individuals participate to contribute to knowledge and progress in treating and preventing diseases and others participate because they have exhausted standard (approved) treatment options.
What is informed consent?
Informed consent is the process of a participant learning key information about a clinical trial/study to determine if they want to participate. Prior to enrollment into a study, a clinical researcher will meet with a potential participant and/or support system. Potential participants are informed about the content/purpose of the study, design of the study, a participant and provider role in the study, duration of the study, risks, potential benefits, required procedures, and key contact individuals. Participants /support system also have the chance to ask questions. If they agree to participate in a clinical trial /study, the participant signs an informed consent document.
Can I leave a clinical trial/study once I enroll?
A participant can leave a clinical trial /study at any time.
What is an institutional review board, or IRB?
An institutional review board is a committee comprised of medical and nonmedical members who review all clinical trial protocols involving human subjects to ensure they are legal, ethical and follow all national guidelines for clinical trials. The involvement of human subjects in a clinical trial is not permitted until appropriate review and approval is completed by the IRB.
What should participants consider before joining a clinical trial? What should they discuss with their health care providers?
It is important to know as much as possible about the clinical trial you are potentially joining and feel comfortable talking about it with your health care team. The following questions might be helpful to consider when discussing a clinical trial with your provider or health care team:
- What is the purpose of the clinical trial?
- Who is going to be in the clinical trial?
- What do researchers hope to learn from the clinical trial?
- How long does the study last?
- What will I be asked to do as a participant?
- Do I still see my regular provider?
- What kinds of tests or procedures are involved?
- How do the possible risks, side effects and benefits affect my current care and treatment plan?
- Who will pay for the experimental treatment? Does my insurance cover the costs?
- Will I get the results of the clinical trial?
- Will I receive any follow-up care after the study has ended?