What is a research study?
A clinical research study is an organized activity designed to learn more about a medical treatment or prevention. There are many kinds of studies.
Studies are done to:
- Test a product, such as a drug or device, for effectiveness, safety or to identify side effects
- Find out what health care practices work best
- Understand health needs, problems or feelings that people have about an illness
- Better understand what causes a particular disease
What is clinical research?
Clinical research involves children and adults who volunteer to participate in specific research studies. These studies are performed under strict guidelines in order to determine how a disease affects the body (clinical research) or to measure the safety or effectiveness of a medical treatment or other intervention (clinical trials).
Clinical research studies seek to answer specific questions. For instance, why are people with atopic dermatitis more prone to skin infections than people without atopic dermatitis? Some clinical research studies focus on the quality of life people experience, while clinical trials may compare the effectiveness of a particular drug to another drug or intervention or to no treatment.
Clinical trials (studies that test a new intervention) as well as mechanistic studies that do not test an intervention, help to advance the concept of "personalized medicine,” which is treatment based on the individual makeup of each person. This approach to healthcare encourages early diagnosis and treatment of diseases prior to the onset of symptoms by studying biomarkers and genes. National Jewish Health continues its world leadership in this cutting-edge gene and biomarker field of medical research.
Clinical trials that test medications are conducted in phases.
- Phase I determines safe dosages of a new drug in a small human population.
- Phase II attempts to find out how well people respond to certain treatments. If enough people respond positively, the study may go on to the next level.
- Phase III enrolls a large number of people (sometimes thousands worldwide) to test drug efficacy and safety.
- Phase IV research requires that a control group receive standard therapy while another group receives the new drug. There also may be other types of Phase IV safety studies.
Before becoming involved in any type of clinical research, interested participants are counseled on the risks and benefits of study participation. Participants give their informed consent and can withdraw from a study at any time. The level and quality of care they receive will not be influenced by a decision to withdraw.
Why is clinical research important?
Clinical research is critical to understanding diseases and improving treatment therapies. Through the years, National Jewish Health has conducted research leading to new and improved treatments for a number of respiratory, allergic and immune diseases. We have helped bring such drugs as Advair, Claritin and Xolair to market.
What are the risks of participating in medical research?
All of the known risks associated with each study are explained in the study informed consent form. The study doctor or coordinator will discuss them with you. If you do volunteer, the researchers will tell you about any new risks discovered during the study.
Possible risks include:
Being asked questions that could make you uncomfortable
Discomfort or side effects* from the research procedures or drugs
*Not all of the risks or side effects may be known when you start a study, but any new findings will be reported to participants.
What is informed consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to participate. To help you decide, the study doctors and coordinators explain the details of the study to you. Then they give you an informed consent document that describes things about the study, such as its purpose, risks, benefits, required procedures and contacts. You will get a copy of the informed consent document, and you may take as much time as you need to decide. You may want to talk over the study with your family, friends or doctor before you make a decision.
What happens if I am injured as a result of participating in research?
If you are injured or become ill as a result of your participation in a study, payment for any care you need may be covered by National Jewish Health, the study sponsor or by your health insurance company. In some cases, you could be personally responsible for paying for your medical care. It is important that you understand who is responsible for paying for any research-related injuries before you decide to participate in a study. Please discuss these concerns with the study doctor or coordinator.
Who regulates medical research?
Overseeing organizations such as the Federal Drug Administration and the Department of Health & Human Services are always regulating medical research activities, but each research site also has its very own regulatory institutional review board (IRB). The IRB is a group of medical professionals, ethicists, and people from the community who protect the rights and welfare of research participants. The IRB reviews each study to make sure that the risks involved are as small as possible and that each volunteer is informed of those risks prior to their participation.
Besides the FDA, who else oversees clinical research trials?
An independent safety committee called an Institutional Review Board (IRB) oversees medical research. The IRB is made up of scientists, physicians and nurses unassociated with the actual research. Once approved, clinical trials are followed closely and progress is reviewed systematically.
Who can participate in clinical research?
All clinical research studies have a series of requirements that must be met; these are known as inclusion/exclusion criteria. Inclusion criteria allow certain persons to participate, while exclusion criteria are what prevent persons from participating. These criteria most often include age, gender, the type and stage of an illness, previous treatment history, and other medical conditions. All of these criteria are not meant to exclude people personally; rather, they are to identify the most appropriate people who are needed for the study (for example, healthy people versus people with an illness the study intervention intends to treat).
What if I decide that I don’t want to participate in research?
Participating in medical research is always and completely voluntary. Choosing not to participate will never affect your care at National Jewish Health. If you decide to volunteer for a research study, you can change your mind and stop at any time. If you decide to stop participating in a study, it is always helpful to the researchers if you tell them why.
What does it mean to participate in clinical research?
Before deciding to participate, you will meet with the healthcare team to ask questions so that you can better understand the study. Here are some example questions:
- What is the purpose of the study?
- If the study involves an experimental treatment, has the experimental treatment been tested before? What makes the team think it will be effective?
- What types of tests and treatments are involved?
- What are the possible risks and side effects of being involved?
Depending on the type of research study being conducted, the process itself may vary. You will participate under the guidance of doctors, nurses, social workers, and other healthcare professionals. They will explain the study guidelines and monitor your health. Some studies may ask permission to stay in touch with you after the study has been completed.
How long does it take it to participate in a clinical research study?
The length of time varies depending on the nature of the study. Clinical research studies involving a new type of therapy or medication typically require more testing and office visits than a person might normally expect for a condition or illness. This is to protect your health and to obtain data needed to determine the effectiveness of the intervention.
Clinical research participants may choose to withdraw from a study at any time. The level and quality of care they receive will not be influenced by a decision to withdraw.
Why should I participate in clinical research?
Clinical research presents you with an opportunity to gain access to new medical interventions, to possibly take a more active role in your healthcare, and to help others by contributing to medical knowledge. Chances are you or someone you know may be alive today thanks to people who have participated in clinical research.
What is the benefit of participating in a clinical research study?
At National Jewish Health, you will have access to some of the best researchers, physicians, and clinical care staff in the nation. As they work to advance the science of medicine, you will play an active part if you choose to participate as a clinical research study volunteer.
The study may not help you personally, but your participation may result in information that will help others in the future. Your involvement may help doctors learn how to prevent diseases or it may lead to new treatments for people with your condition. While you are in the study, your health may get better, it may stay the same, or it may even get worse. No one can completely predict the outcome of a research study or how it might affect you.
You may receive medications or other treatment options as part of the study and discuss how your body feels in response to them. You may not be asked to test any intervention, but instead asked to provide blood samples or other specimens for testing specific to your disease. In all cases, you may be compensated for your time, and participation may play a role in treatment discoveries, cures, and preventions for many diseases and conditions.
What questions should I ask before I take part in a study?
It is important for you to know as much information as possible about a study before you decide to volunteer to participate. If there are any issues that concern you, ask questions. Most of the following questions are answered in the study informed consent document. But, the conversation with your study doctor should be equally as informative.
Here are some questions you should be able to answer after you talk with the research staff:
- What is the purpose of this study?
- How will this research help?
- What tests or procedures will be done?
- Will I be asked to take investigational drugs or undergo experimental procedures?
- Is it possible that I receive placebo (inactive ingredient) and not a drug?
- What are the potential risks and benefits of taking part of the study?
- What other options do I have if I decide not to participate?
- What will happen to the specimens (blood, tissue or genetic) that I give?
- Who has approved this research?
- What happens if my condition gets worse while I'm in study?
- Who will pay my medical bills if I become sick due to participating in the study?
- Will it cost me anything to be in the study?