FAQ About Research

Clinical trials Management FAQ

Frequently Asked Questions About Research

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.
Where do 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 treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
When do I get paid?
Patients are paid differently for every trial. Payments are generally made within 30 days of the end of your participation in a trial. However, if the trial has a number of visits, or there are more than 60 days in between visits, then payments are made during the trial.
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 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 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 treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (See: What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and 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.
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.
How is my safety and privacy protected?
IRB The Institutional Review Board, is a diverse group of health care professionals and members of the public that reviews and approves clinical research to assure They are run in a way that protects volunteers. Research Site The research site is there to answer your study question, to keep an eye on your progress while you are participating in the study, and to help you from the beginning to end of the research study. Government Agencies The FDA makes sure the medicines, vaccines and medical devices are effective and safe. Privacy Health information and your identity are protected when part of a clinical research study. The consent you sign will explain how. Sponsor The clinical research sponsor carefully watches the progress of the study and the volunteers participating in the research study. What is a clinical study? A clinical study is a research study with human volunteers to research specific health questions. Carefully conducted clinical studies are the fastest and safest way to find treatments that work and ways to improve health. Interventional studies determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational studies address health issues in large groups of people or populations in natural settings.
Why participate in a clinical study?
Participants in clinical studies 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.
Who can participate in a clinical study?
All clinical studies 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 study are called “inclusion 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 study, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical study, 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 research study?
The clinical research study process depends on the kind of research being conducted (See Phase Trials). The clinical research team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the study, give specific instructions for participating in the study, monitor the participant carefully during the study, and stay in touch after the study is completed. Some clinical research studies involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of studies, the participant works with a research team. Clinical study participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. Study Phases Phase 1: includes initial research studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and – to gain early evidence of effectiveness – may include healthy participants and/or patients. Phase 1/Phase 2: for research studies that are a combination of phases 1 and 2. Phase 2: includes controlled clinical trials conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Phase 2/Phase 3: for research studies that are a combination of phases 2 and 3. Phase 3: includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and is intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling. Phase 4: post-marketing research studies to delineate additional information including the drug’s risks.
What is an informed consent?
Informed consent is the process of learning the key details about a clinical research study 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 doctors and nurses involved in the research explains the details of the study. If the participant’s native language is not English, translation assistance can be provided. 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 study at any time.
What are the benefits and risks of participating in a clinical research study?
Benefits Clinical studies 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 by contributing to medical research. Receive compensation for time and travel as well as free study associated health screenings, lab exams, and medications. Risks There are also risks to clinical trials: There may be unpleasant, serious or even life-threatening side effects to treatment. The 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.