Frequently Asked Questions
Clinical research trials contribute to evidence-based medicine by helping find new and better ways to treat patients. Research’s contributions play a vital role in the advancement of medical therapies, medications and technologies. Without research, these advancements would not exist.
Clinical trials are part of clinical research and the heart of all medical advances. Clinical trialsexamine new ways to prevent, treat and detect disease. This involves using new drugs or devices, or approved drugs or devices.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
In the United States there are various committees, regulatory groups, rules and regulations (federal, state and local) that oversee clinical trials and foremost protect the safety of clinical trialparticipants.
(Source: NIH: National Institutes of Health)
Clinical research trials are conducted in phases.
Phase I: An experimental drug or treatment is given to find a safe dose, to decide how the new treatment should be given or to see how the new treatment affects the human body. Usually 10-15 people participate in the clinical trial.
Phase II: An experimental drug or treatment is given to a group of 100-300 people to see if it is effective and to further evaluate its safety.
Phase III: An experimental drug or treatment is given to a larger group 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.
Phase IV: Post marketing studies are conducted to evaluate risks, benefits and optimal use of the drug or treatment or a new indication for already approved drugs.
Benefits: Clinical trials offer high-quality care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good as, or better than, the new approach.
- If a new treatment is proven to work and you are taking it, you may be among the first to benefit.
- By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
- You have the chance to help others and improve cancer treatment.
Risks: New treatments under study are not always better than, or even as good as, standard care.
- If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach. New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.
- Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
There is no cost to the clinical trial participant. Frequently the sponsor of the clinical trial provides a stipend to participants for their time and/or travel expenses.
No. However, you may request that your primary care physician be notified if you decide to participate in a clinical trial.
The process during a clinical trial depends greatly on the kind of study being conducted. The study trial team includes, doctors, nurse practitioners, nurses, study coordinators, and other health care professionals. The study team will check the health of the potential volunteer at the beginning of the trial, give specific instructions for being part of the study, monitor the volunteer carefully for the duration of the trial and stay in touch once it has been completed.
Clinical trials are funded, or sponsored by a variety of organizations, foundations, voluntary groups, and pharmaceutical companies, additionally clinical trials can also be sponsored by federal agencies such as the National Institutes of Health, the Department of Defense and the Department of Veteran’s Affairs. Trials can take place in many different settings, such as hospitals, universities, doctors’ offices, or community clinics.
All clinical trials have set of guidelines about who can participate. The factors that allow someone to be in a clinical trial are called “inclusion criteria” and those that don’t allow someone to participate 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 potential volunteer must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, and others need healthy volunteers. The inclusion and exclusion criteria are not used to reject people personally, the criteria are used to identify appropriate participants and keep them safe.
Potential volunteers should know as much as possible about the clinical trial and feel comfortable asking the members of the study team questions about it, the care expected in a trial, and the cost of the trial. The following questions could be useful for the potential volunteer to discuss with the study staff some of the answers are also found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers think 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 potential risks, side effects, and the benefits in the study compare with my current treatment?
- How might this study affect my daily life?
- How long will the study last?
- Who will pay for the experimental treatment?
- Will I be reimbursed for expenses?
- What type of long-term follow up is part of this trial?
- How will I know that the experimental treatment is working? Will results of the study be provided to me?
- Who will be in charge of my care?
Although each study population is different each potential volunteer receives the same high quality care. This will include a medical history, list of all current medications, screening exams, and study specific diagnostic tests.
Sometimes the study staff will require a copy of a volunteer’s medical record for review, and sometimes approval from their current personal physician before you can be enrolled into a study.
All of this is to make sure that each possible volunteer is suitable for the study they are being screened for.
Before a potential volunteer meets with a research coordinator or doctor they should plan ahead and write down possible questions to ask. It is ok to have a friend or relative come along for support and to hear the answers to the questions. They can take notes or ask to record the discussion on a tape recorder to replay later.
Every clinical trial in the U.S must be approved and monitored by an Institutional Review Board (IRB). The IRB is there 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 medical research involving people must, by federal regulation have an IRB that initially approves and periodically reviews the research.
Every research participant must go through the informed consent process; this is so that the volunteer understands the risks and freely consents to participate in the study.
Informed consent is the process by which a fully informed volunteer can participate in the decision to be part of a research study.
The major elements of informed consent are:
- the purpose of the study/research being conducted
- duration of the study
- The relevant risks and benefits of being part of the study
- the required procedures
- key contacts
- and the acceptance to participate in study by volunteer
The informed consent is not a contract and a volunteer can withdraw from a clinical trial at any time.