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.
What are clinical trials? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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? [Show Answer]
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.
Can a participant leave a clinical trial after it has begun? [Show Answer]
Yes. You can leave a clinical trial at any time. When withdrawing from the trial, you should inform the research team about your decision for leaving the study. Choosing to withdraw from the trial will not affect your regular treatment.
What is a placebo? [Show Answer]
Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. If a placebo is part of a study, you will be informed in the consent form given to you before you agree to take part in the study.
What are single-blind and double-blind studies? [Show Answer]
In single- or double-blind studies, the participants don't know which medicine is being used. Blind studies are designed to prevent anyone from influencing the results. In single-blind studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the rest of the study team does not know. If medically necessary, however, it is always possible to find out what the patient is taking.
What if I have trouble understanding English? [Show Answer]
If English is not your first language, The Reading Hospital has medical interpreters on staff who can help you understand the details of a clinical trial.
What should people consider before participating in a trial? [Show Answer]
People should know as much as possible about the clinical trial and feel comfortable asking the study team questions about it. The following questions might be helpful for you to discuss with the study team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
- What kinds of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
- What are my treatment options if I don’t join the trial?
