Patients taking part in DDI clinical research studies at Cleveland Clinic are seen by a team of expert doctors, nurses, technicians, and support staff. Clinical research patients often are first to receive promising new treatments before they become available in the community.
Patients are helping others with the same disease, both today and in the future.
What are the Risks and Benefits?
It is important to understand that some risks are involved in clinical research, just as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time.
Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. 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. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, you will know that the knowledge developed may help others.
What is the “informed consent process”?
Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.
Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information.
The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract.
Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.
Who supports clinical research studies?
Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs. Trials can occur at sites as varied as hospitals, universities, doctors’ offices, or community clinics.
How are studies designed?
Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:
- Who is eligible to participate in the trial
- Details about tests, procedures, medications, and dosages
- The length of the study and what information will be gathered
A clinical study is led by a principal investigator, who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.
Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.
What Are the Main Types of Clinical Trials?
Clinical trials are conducted in "phases." The trials at each phase have a different purpose and help researchers answer different questions.
Phase I trials—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II trials—The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
Phase III trials—The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV trials—After a drug is licensed (approved by the FDA) or treatment is launched, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use. These long–term studies involving large groups of participants continue to see if any unexpected side effects occur in a small percentage of individuals.
What happens when a clinical research study is over?
After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.
Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.
What should I consider when deciding to participate?
It is important that patients be well informed and feel confident and secure about participating. Before deciding to participate, you should talk with your own doctors, family members, and Digestive Disease Clinical Research personnel.
Be sure you know the answers to the following questions before you make your decision:
- What is the purpose of the study?
- What is required of me?
- What is my role in the study—am I a healthy volunteer or a patient volunteer?
- Will the study directly benefit me?
- Will the study benefit others?
- Are there risks? If so, what are they and what are the chances that they will occur?
- What discomforts are involved?
- What is the total time involved?
- Are there other inconveniences?
- Have I discussed participation in the study with those who are important to me, such as family and friends?
- Do I wish to participate in this study?