Frequently Asked Questions
Volunteering for a clinical trial is an important decision. Listed below are some questions and answers that may guide you in your decision-making process.
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What are clinical trials?
A clinical trial is a research study in human volunteers that answers specific health questions. Clinical research studies aim to determine if a drug or treatment is safe and effective. Carefully conducted clinical trials are the safest and fastest way to discover treatments that work in people to improve their health.
Who can participate in a clinical trial?
Researchers typically look for people who have a specific disease or who are at high risk to develop a certain disease. Healthy people are needed for some trials. Certain criteria such as age, gender, type of disease, previous treatment history and other medical conditions, are used to identify appropriate patients and keep them safe.
What happens during a clinical trial?
For all types of trials, you work with a study team which includes doctors, nurses and other health care professionals. The study team will give you specific instructions for participating in the trial and monitor you carefully throughout the study.
What are the different phases of clinical trials?
Clinical trials are conducted in phases. The phases of each trial have different purposes and help scientists answer different questions.
- Phase I – researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dose range, and identify side effects
- Phase II – the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and then to further evaluate its safety
- Phase III – the experimental study drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely
- Phase IV – post-marketing studies provide additional information including the drug or treatment risks, benefits and optimal use
Why should I participate?
Your role in clinical research is crucial in advancing science and technology that will improve the health of future generations. Without volunteers, research studies cannot be accomplished.
What Are the Costs?
All testing and services that are specifically related to the study and would not have been performed if you were not in the study will be provided at no cost to you and will not be billed to you or your health insurer or Medicare. Costs that are part of your normal medical care that you would have even if you were not in this study will be billed to your health insurer or Medicare.
What are the Risks and Benefits?
It is important to understand that some risks are involved in clinical research, just as in routine medical care and activities of daily living. The specific risks associated with any research protocol are described in detail in the informed consent document. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks against possible benefits. Clinical trials can provide access to new or experimental treatments that otherwise aren’t available. You may or may not receive direct benefit for yourself as a result of participating in research, but you will know that the knowledge developed may help others.
What is informed consent?
Informed consent is the ongoing process of learning the facts about a clinical trial. The research team involved in the trial explains the details of the study, such as its purpose, duration, required procedures, and key contacts. These along with risks and potential benefits are explained in the informed consent document. If you decide to join the study, you will be asked to sign the informed consent document. Informed consent is not a contract, you may withdraw from the trial at any time.
How is the safety of the participant protected?
The trial follows a carefully controlled protocol, which details what researchers will do in the study. Clinical research is federally regulated to protect the participants. Every clinical trial at The Reading Hospital must be approved and monitored by the Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. The study doctor should not be used as a replacement for your primary care doctor. During the trial, the study doctor will ensure that other medications or treatments will not conflict with the protocol. Most clinical trials do not provide extended or complete primary health care.