Clinical Research Frequently Asked Questions
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 should you 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.
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 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.
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.
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.