The following information is intended to provide prospective study patients with information regarding clinical research and their potential involvement.
What is a Clinical Trial?
A clinical trial (clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest method of determining treatment options that work in people and ways to improve health in general. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Why participate in a trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available and help others suffering from similar conditions by contributing to medical research.
Who can participate?
All clinical trials have guidelines about who is able to participate. Using inclusion and exclusion criteria is an important principle of medical research that is used to generate reliable results. These criteria are based on factors such as age, gender, type and stage of disease, previous treatment history, and other medical conditions. Some research studies seek participants with illnesses or conditions to be studied in a clinical trial, while others need healthy participants. Criteria help to ensure that researchers will yield conclusive and reliable results.
What can I expect for the study process?
The clinical trial process depends on the kind of trial being conducted. The research team consists of doctors, nurses, research assistants and other health care professionals. The team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials involve more tests and doctors visits that the participant would normally have for an illness or condition. For all types of trials, the participant works with the research team. The most successful clinical research is obtained when there is regular patient-participant interaction.
What are the risks associated with participating in a clinical trial?
- There may be unpleasant, serious or even life-threatening side effects to treatment
- The treatment may not be effective for the participant
- The protocol may require more of participant time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participant. The trials follow carefully controlled protocol, a study plan which details what researchers will do in a study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Participant’s name and other identifying characteristics will remain confidential and will not be mentioned in these reports.