What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a predefined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
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.
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 (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.
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 doctors and nurses involved in the trial explain 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 trial at any time.
What are the benefits and risks of participating in a clinical trial?
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 by contributing to medical research.
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.
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.
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 Veterans 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 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.
10 Totally Incorrect Things You Probably Believe About Clinical Trials
1. Myth: You have to quit the other medications you're already taking while you're participating in a clinical trial.
This may be true, depending on the clinical trial. Every trial has individual criteria for its participants, and medication history is definitely a factor that researchers consider when determining eligibility.
2. Myth: Clinical trials are expensive.
This is false. Travel to and from the appointment may not be covered, but the trials usually are. Typically clinical trials don't cost anything for the patient because they are federally or privately funded. Most health insurance plans also cover routine patient visits that are associated with the clinical trial. Additional research costs for things like blood tests and scans are often covered by the trial sponsor.
3. Myth: Once you start a clinical trial, you have to finish it.
This is false! Participants can drop out of clinical trials if they choose to. Follow-up visits are necessary to ensure the health of the patients, but not finishing a clinical trial is absolutely allowed.
4. Myth: You can be part of a clinical trial only if you live near a major hospital.
This, too, is false. There are clinical trials held out of smaller medical offices, although it's not as common. To help participants who live farther away, some trials assist in arranging transportation and even accommodations in hotels.
5. Myth: If you're part of the placebo group, you will not receive the same level of care as the treatment group.
This is false. Whether participants are on a placebo or the treatment, they will be receiving the same level of attention from the trial staff. Research coordinators and trial staff often don't even know which patients are receiving a placebo in order to ensure unbiased results. Regardless of which group the participant belongs to, research staff can recommend dropping out of the trial if the patient's conditions worsen or fail to improve.
6. Myth: You don't have to go to regular doctor visits if you're participating in a clinical trial.
This is also false! Clinical trials can't replace appointments with your regular doctor. You'll still need standard prescriptions, surveillance tests, and other procedures as you're going through the clinical trial. You'll also need to keep your regular doctor informed about your participation in the study.
7. Myth: Clinical trials last for months and months.
This is sometimes true. Some trials are only one to three months in duration. Others can be six to twelve months or longer.
8. Myth: You can't participate in a clinical trial if you're in remission at the time.
This depends on the study. Although many clinical trials are for patients with moderate to severe disease, not all studies are.
9. Myth: There is no information available to clinical trial participants on the earlier results of the study.
This is false. Information from earlier completed clinical trials should be accessible for patients of the current trial to review.
10. Myth: Participants cannot continue to use the study's drug or therapy after the trial ends.
This is sometimes true, depending on the sponsor of the study. Some allow participants to continue the treatment in an open-label extension study, while others may have to wait for approval from the FDA.
- *All facts and information courtesy of Buzzfeed and the Crohn's & Colitis Foundation.