What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (Insert link here -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.
Who can participate in a clinical trial?
All clinical trials have guidelines/criteria about who can participate. 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. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.
Why should I participate in a clinical research trial?
It is important to remember that your participation is entirely voluntary. People participate in clinical research trials for many different reasons. They may want to take advantage of the opportunity to receive investigational drugs and treatments that are not currently approved for use outside of research studies. They may want to take a more active role in their own health care. Some people may participate because they feel good knowing that the information obtained from their participation will ultimately benefit future generations to come. In addition, participants can receive medical evaluations, study-related lab tests and study medications at no cost and are usually compensated for their time and travel. Medical research studies provide an opportunity for groups of people who were not usually asked to participate in research studies in the past, such as women, African Americans, Hispanic Americans, Asian Americans, American Indians, etc., to contribute to the study.
Why are medical research studies important?
Medical research studies give scientists and doctors essential information about the safety and effectiveness of new treatments and procedures. Although much can be learned from laboratory studies and scientific research, only clinical trials can show whether new treatments actually benefit people. Information gained in these trials allows researchers and doctors to develop new and improved ways to prevent, diagnose and treat diseases.
What is an informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. This process involves the various discussions that take place as a study is being fully explained to you (and your questions are being answered to your satisfaction) by the principal investigator (physician) and/or study coordinator. It also involves the reading and signing of a document called the “informed consent document (ICD).” The physician or study coordinator will provide 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. You have the right to stop participating in a study, for any reason, and at any time, without losing any of your medical care options.
By signing this form, you are stating that you have given your informed consent to participate; you are verifying that you have volunteered to participate after being told everything that the study involves.
You have the right to know:
- The purpose of the research study that you are being asked to join
- All of the risks that you are taking if you choose to take part in a study as well as anything that might be of benefit to you
- Other medical options available to you, if you choose not to participate in the study
Your informed consent is always confirmed before your participation in a study begins (before study procedures are performed). The informed consent process continues throughout the entire study because your “informed consent” is only genuine if you are truly aware of everything involved with participating in the study.
What are the risks and benefits of participating?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their health care.
- Gain access to new research treatments before they are widely available.
- Help others by contributing to medical research.
There are also risks to clinical trials:
- There may be unpleasant, side effects to treatment. Some side effects can be minor, some can be serious, and some can actually be life-threatening
- The treatment may not be effective for the participant. Some studies use a “placebo” which is an inactive pill, liquid, or powder that has no treatment value. In this case, your symptoms might get worse since you are not receiving any possible treatment for your condition. Even if a study does not use a placebo, the study drug/treatment that you receive may not help you. This is true both for drugs and treatments that are approved by the FDA and also for those that are experimental.
- 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.
Every clinical trial in the U.S. must be conducted under the oversight of an Institutional Review Board (IRB). An IRB is a group of doctors, scientists, and other people from the community who help to make sure that your rights and your safety are being protected as a research participant. They also review the protocol to make sure the study will be conducted fairly and ethically. The IRB also decides how often to review the trial once it has begun. Based on this information, the IRB decides whether the clinical trial should continue as initially planned and, if not, what changes should be made. An IRB can stop a clinical trial or place a hold on it if the researchers are not following the protocol or if the trial appears to be causing unexpected harm to the participants. They can also stop a clinical trial if there is clear evidence that the new intervention is effective, in order to make it more widely available.
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 side effects and adverse reactions?
Side effects are any undesired actions or effects of 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 (See Confidentiality Regarding Trial Participants).
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 kind of preparation should a participant make?
A potential participant should be prepared for the meeting with the research coordinator or doctor by:
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
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 with their primary health care provider?
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 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.
Who pays for a clinical trial?
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 happens to my personal information?
At no time will our research staff reveal participants’ names, social security numbers, addresses or other identifying information without your knowledge. We give participants a number or code to protect their identities. When the clinical trial results are published, identifying information is not used. The research team may access a clinical trial’s information to help the clinical trial sponsor submit data to the FDA to get the treatment approved. Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information.
What are the different phases of a clinical trial?
Clinical trials usually fall into four categories. Each phase has a different goal and is designed to answer a different question:
Phase I:
Phase 1 clinical trials are designed to test the safety of a new drug or medical procedure in first human usage. They usually enroll a small number of participants and may only involve a few dozen people. These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe.
Phase II:
Phase 2 clinical trials continue to test the safety of the new treatment and find out if it is effective. They usually enroll more participants.
Phase III:
Phase 3 clinical trials are intended to confirm whether a new treatment is effective and gather information about its side effects. These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random. They usually involve 1,000 people or more.
Phase IV:
Phase 4 clinical trials occur after a new drug has been approved for use by the FDA. These trials evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials, how the drug compares to other drugs already available on the market, or the best ways to use the new drug. Thousands of people are involved in a phase IV trial.
What happens after the trial?
After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.
Is there a potential conflict of interest?
KMRC workers never receive payments for recommending, referring or enrolling patients in our clinical research trials. Some health care workers are paid fees for recommending, referring, or enrolling patients in clinical trials. This information is generally not discussed during informed consent, but potential volunteers may ask if the referring health care provider will receive monetary compensation, or if investigators have other potential conflicts of interest.
What if I have other questions, concerns, or comments?
If you did not find the answer to your question about medical research studies here, please email the KMRC Regulatory Department with your inquiry; you may also call us at 859-225-5672, and ask for a member of the Regulatory Department.
You have the right to know the purpose of the research study that you are being asked to join.