What is clinical research?
Clinical research is scientific investigation designed to uncover data about preventing, diagnosing, treating, or improving outcomes of illnesses and medical conditions. Clinical research may start with an idea in a laboratory, progress to animal studies, and then go through phases of testing in humans. Clinical trials are a part of clinical research and are the basis of most advances in medicine. Before drugs and devices can be used by the public, they must pass rigorous testing in clinical trials to make sure they are safe and effective.
What are the types of clinical trials?
- Natural history studies gather information about how disease and health progress.
- Prevention trials investigate ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
- Screening trials test ways to detect certain diseases or health conditions.
- Diagnostic trials examine tests or procedures for identifying a particular disease or condition.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to therapies.
- Quality-of-life trials explore and measure ways to improve the comfort and quality of life of people with chronic illnesses.
What is the difference between the MURDOCK Study Community Registry and a clinical trial?
The MURDOCK Study Community Registry is a natural history study (see description above), and as a MURDOCK Study participant, you may have an opportunity to participate in other clinical trials. By providing information about your health, researchers can determine if you might qualify for a clinical trial. It is always your choice to participate.
What is a biorepository?
A biorepository is a collection of biological specimens, such as blood and urine, gathered from volunteers who consent to having their samples used for a variety of research purposes. There are biorepositories located throughout the world, focusing on a variety of diseases, regions, and populations. The LabCorp-Kannapolis Biorpository stores nearly 450,000 MURDOCK Study biospecimens.
Check out this article from Genome Magazine for a more in-depth look at the function, structure, and future of biorepositories.
Why should I consider participating in clinical trials?
The benefits include:
- Gaining access to therapies, medications, or devices not yet widely available.
- Helping others by advancing scientific knowledge.
- Taking an active role in your own health care.
- Receiving free or subsidized medical attention from a research team that includes doctors and other health professionals.
What is “informed consent”?
Informed consent is a process that begins when you first talk about the clinical trial with the research staff and continues until the end of your participation. A consent form is a document with details about the study, such as its purpose, what to expect if you participate, procedures and products, and important contact information. It describes your rights as a study participant and includes information about the risks and potential benefits, including how your privacy and safety will be protected and ensured. Signing the consent form means you understand what is involved and that you are voluntarily taking part in the study. A consent form is not a contract, and even after signing the consent form, you may withdraw from a study at any time.
How do I decide whether to participate in a clinical trial?
The choice is yours. Before you decide to participate, consider talking with your family, friends, and doctor. Ask questions, and carefully review the consent form to make sure you understand the risks and benefits of participating in the study.
Questions to consider include:
- What is the purpose of the clinical trial?
- What are the alternatives if I decide not to participate?
- Who will be responsible for my care?
- What are my responsibilities if I participate?
- How long will the study last?
- What are the possible short- and long-term side effects, risks, and benefits?
- What kinds of therapies, procedures, and/or tests will I undergo?
- Will I have to pay for any of the tests or procedures? What will my insurance cover?
- Will I be reimbursed for travel or child-care expenses?
How can I learn more?
- The Center for Information and Study on Clinical Research Participation
- The National Institutes of Health
- ClinicalTrials.gov—a registry and results database of federally and privately supported clinical trials