Choosing to participate in clinical research study is an important personal decision and does involve certain risks and benefits. Please talk to your doctor if you are interested in joining a clinical trial. The below information can help you understand the basics of clinical research and in making informed decisions. show more ›
What Is Clinical Research?
The primary goal of clinical research is to advance medical knowledge about a disease or condition and to find better future treatments for patients. Volunteers in a clinical research study receive specific interventions according to an approved research plan, or protocol.
An intervention can be a medicine, device, procedure, or behavioral change, such as diet. For the purposes of this article, we will discuss clinical research involving medications.
Most often, the investigational medication is compared to a placebo. The placebo has no active medical ingredient in it, but looks and feels indistinguishable from the investigational drug. This way, the patient volunteers (and often the doctors) do not know which group is getting the investigational drug and which group is getting the placebo. This helps prevent any bias in the way people respond. The placebo looks exactly like the investigational medication, but doesn’t contain any active ingredients. Other times, the investigational medication is compared to an existing medication that’s already available. Sometimes a medication that is approved for the treatment of a specific disease can also be tested to see if it can treat another disease.
Data collected from clinical studies helps determine whether or not the medication is safe and effective. For example, a study can help find out if a blood pressure medication actually lowers blood pressure in patients with hypertension without causing major side effects.
Who Sponsors Clinical Research?
Clinical research is sponsored by government agencies, private organizations, foundations, or individual researchers who are seeking ways to improve the health of patients. The US Government agencies include the National Institutes of Health (NIH), the Department of Defense (DOD) and the Department of Veteran’s Affairs (VA). Private organizations include pharmaceutical, biotechnology, and medical device companies and health care institutions, such as academic medical centers and health maintenance organizations (HMOs).
Who Conducts Clinical Research?
A primary investigator typically conducts a clinical research study that involves medications. Typically, doctors or qualified healthcare professionals who specialize in the disease, for which the medication is being evaluated, serve as primary investigators. The study site may be in a hospital, a clinic, or a doctor’s standalone office.
Usually, it takes a team of healthcare professionals to conduct a research study. Besides the primary investigator who oversees the study, the research team may include more doctors, physician assistants, nurses, medical assistants, and other healthcare professionals. The study coordinators, who manage the day-to-day activities of the research study, are often nurses.
Why Conduct Clinical Research?
Clinical research is primarily designed to increase medical knowledge related to the treatment, diagnosis, and prevention of conditions or diseases. Common reasons for conducting clinical studies include:
- Evaluating one or more interventions for a condition
- Examining one or more interventions to identify or diagnose a particular condition
- Seeking ways to prevent the initial development or recurrence of a condition
- Exploring methods for identifying a condition or the risk factors for that condition
- Investigating and measuring ways to improve the comfort and quality of life for patients
Why Participate in Clinical Research?
Patients choose to participate in clinical trials for many reasons. It is important to remember the following:
All research participants receive study-related care at no cost, including medication(s), tests, and overall health monitoring, and they may be compensated for their time and/or travel. The safety and effectiveness of the investigational medication is still being evaluated, and, like approved medications, investigational medications may have potential side effects. There is also the possibility that participants may receive placebo. Participants can discuss the potential risks and benefits with the study staff to see if being part of a research study may be right for them.
Participating in a research study contributes to advancing medical knowledge. The results may make a difference in the care of future patients by providing information about the benefits and risks of interventions. Medical advances depend upon participant involvement. Without study participants, clinical research simply cannot happen.
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