Things To Consider Before Becoming a Volunteer
» Why participate in a clinical trial?
» Who can participate in a clinical trial?
» What happens during a clinical trial?
» What is informed consent?
» What are the benefits and risks of participating in a clinical trial?
» What are side effects and adverse reactions?
» How is the safety of the participant protected?
» What should people consider before participating in a trial?
» Does a participant continue to work with a primary health care provider while in a trial?
» Can a participant leave a clinical trial after it has begun?
» Where do the ideas for trials come from?
» Who sponsors clinical trials?
» What is a protocol?
» What is a placebo?
» What is a control or control group?
» What are the phases of clinical trials?
» Will it cost me anything to participate?
» Will I be compensated for my participation?
» How long do studies last?
» How long do visits last?
» What are your hours?
» What if I have a problem?
» What if I want to keep taking the medication?
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Clinical trial volunteers are an essential part of medical research. By participating in a clinical trial, you will contribute to the discovery of therapies that may one day relieve or eliminate an illness. In addition, you will receive personal and specialized medical attention from our physicians and clinical staff, as well as free medical tests and study medication.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Once you've signed the consent form, you will be ready to take part in the study. You will probably need to have blood tests or imaging tests done before you start treatment. A full medical history and physical exam are also usually done. The results are needed before you start the actual study to be sure that you meet the eligibility criteria and to help ensure your safety.
You may have tests done more often, to find out how well the treatment is going and to look out for your welfare. It is likely that you will get more attention as a study participant than you would otherwise. The investigators and coordinators may examine you more often and will want to know if you are having any side effects (called adverse events) while being treated.
Because the possible complications may not fully be known, it is very important to let the research team know about anything out of the ordinary. They can then decide if symptoms you are having are related to the study, and if they need to be treated or your therapy needs to be changed.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the investigators and coordinators involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the benefits and risks of participating in a clinical trial?
Each clinical trial offers its own opportunities and risks, but most have some things in common.
Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others who have the same condition in the future by helping to advance research.
Risks
There are risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
Potential risks and benefits vary from trial to trial. However, if you are interested in volunteering for a specific study potential risks and benefits will be explained to you before you give your consent to participate. You will also be able to ask questions of our clinical staff if you have any concerns that are not addressed.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care 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 experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental 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 experimental 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 experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
- In Phase I trials, 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 dosage range, and identify side effects.
- In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) 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.
- In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Will it cost me anything to participate?
No. All medical care, tests, and medications related to the clinical trial are provided free of charge.
Will I be compensated for my participation?
Yes, we provide compensation for participation for loss of time or work in nearly all of our trials.
How long do studies last?
This varies depending on the clinical trial. This information would be made available to you once you have qualified for a particular study. An estimate could be made when you call our office.
How long do visits last?
This will also vary depending on the clinical trial. Most visits for any study at our clinic are at least 30 minutes and some may be a few hours. The initial visit will be longer because it will be necessary to assess your history and discuss the consent.
What are your hours?
Our office is open Monday through Thursday, 7:00am to 5:00pm, and Friday, 7:00am to 4:00pm.
What if I have a problem?
If you have any questions or problems, during clinic hours you can call our contact numbers and a research associate or staff physician will be able to assist you. After clinic hours, you will reach the answering service that will be able to page an appropriate person to address your concerns. Our Physicians and professional staff are available 24 hours a day, 7 days a week.
What if I want to keep taking the medication?
Because most of the medications we study are investigational and have not yet been approved by the FDA for general release to the public, continuing the medication after your clinical research participation ends usually is not an option.