Clinical Trials
What is a Clinical Study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies.
Clinical Trials
In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Observational Studies
In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
Conducting Clinical Trials
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other healthcare professionals.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.
Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study.
The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before enrolling.
Who Can Participate in a Clinical Study?
Clinical studies have standards outlining who can participate, called eligibility criteria, which are listed in the protocol. Some research studies seek participants who have illnesses or conditions that will be studied. Other studies are looking for healthy participants. And some studies are limited to a predetermined group of people who are asked by researchers to enroll. Working with your healthcare provider you can determine if you meet the requirements for a particular study.
Georgia CORE Brings Cancer Research to Georgia
Georgia CORE is a nonprofit enterprise working to strengthen the quality of cancer care in Georgia.
Georgia CORE marshals several cancer-focused entities into a single force to help Georgians fight the disease. Specifically, Georgia CORE:
-
accelerates the exchange of new knowledge and promising practices of cancer care among Georgia healthcare providers;
-
expands the number and reach of new clinical trials and treatments across the state;
-
promotes cancer awareness, prevention and screening in communities throughout Georgia; and
-
generates broader, deeper support for patients, caregivers and survivors by helping them locate doctors, cancer centers and community resources in Georgia.
The sum total of these efforts is a healthier Georgia – with a higher quality of cancer care and a greater likelihood of discovering breakthrough therapies for the disease.
Questions to Ask
Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document.
Many of these questions are specific to clinical trials, but some also apply to observational studies.
-
What is being studied?
-
Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
-
What are the possible interventions that I might receive during the trial?
-
How will it be determined which interventions I receive (for example, by chance)?
-
Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
-
How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
-
What will I have to do?
-
What tests and procedures are involved?
-
How often will I have to visit the hospital or clinic?
-
Will hospitalization be required?
-
How long will the study last?
-
Who will pay for my participation?
-
Will I be reimbursed for other expenses?
-
What type of long-term follow-up care is part of this trial?
-
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
-
Will results of the study be provided to me?
-
Who will oversee my medical care while I am in the trial?
-
What are my options if I am injured during the study?