Patients- FAQs
– What is a clinical trial?
A clinical trial is a research study conducted with volunteers to evaluate a new medication, device, or treatment procedure. These trials are designed to determine the safety and effectiveness of the intervention and to collect data on its potential benefits and risks.
– Why are clinical trials important?
All drugs and treatments have to be tested before they are available to patients, so clinical trials are crucial for advancing medical knowledge and improving patient care. They help researchers evaluate the treatment or medication to make sure they are safe and effective for the patients the intervention was designed for.
– Who can participate in a clinical trial?
To participate in a clinical trial, the research team has to evaluate your fit based on the eligibility criteria. This varies depending on the specific study protocol. Factors such as age, gender, medical history, and the type of disease being studied can all influence whether an individual can participate.
– What are the different phases of clinical trials?
Clinical trials typically progress through four phases:
Phase I: Uses small group of volunteers to help researchers determine appropriate dosing, the safety of the intervention, and what the common side effects are.
Phase II: Further assesses the safety and efficacy of the intervention in a larger group of participants with the disease or condition being studied.
Phase III: Compares the intervention to existing standard treatments in a larger population to further evaluate effectiveness and monitor side effects.
Phase IV: Conducted after the intervention has been approved for use by regulatory agencies like the FDA and involves ongoing monitoring of safety and effectiveness in real-world settings. Also called post-marketing studies.
– What are the potential risks and benefits of participating in a clinical trial?
Participating in a clinical trial can provide volunteers access to new investigational treatments, close medical monitoring and care, and the opportunity to contribute to scientific research. However, there are also potential risks, including unknown side effects, inconvenience, and the possibility of receiving a placebo (inactive treatment) instead of study drug or treatment.
– How are participants protected during a clinical trial?
Clinical trials are conducted according to strict ethical and scientific standards to protect the rights and well-being of participants. Institutional review boards (IRBs) or ethics committees must review and approve study protocols before anyone can participate. Before enrolling in a trial, participants must provide consent, which includes detailed information about the study’s purpose, procedures, risks, and benefits. This process is called informed consent, and can be thought of as an ongoing conversation rather than a one-time occurrence because the study team will keep you informed of any new risks or benefits identified throughout your participation.
– Will I have to pay to participate in a clinical trial?
There are no costs for you to be a volunteer in a clinical trial. Study sponsors will cover the costs of the experimental intervention, study-related medical tests like lab work, and procedures.
– Can I withdraw from a clinical trial if I change my mind?
Yes, participants have the right to withdraw from a clinical trial at any time, for any reason, without penalty. It is important to discuss any concerns or decision to withdraw with the study team to ensure proper follow-up care and documentation.