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What is a clinical trial?
A clinical trial is a research study that uses volunteers as test subjects in pursuit of better patient care. An interventional clinical trial seeks to answer questions surrounding a new drug, new combinations of drugs, novel uses for existing drugs, new surgical procedures, or other aspects of patient care by providing an intervention and then observing the effects. An observational clinical trial seeks to answer similar questions without directly assigning an intervention to study participants.
Who oversees a clinical trial?
Clinical trials are overseen by a principal investigator, often a physician, and supported by a research team including physicians, nurses, and other health care professionals. These trials are sponsored by the federal government, pharmaceutical and biotechnology companies, universities, or physicians groups. Their efforts are supervised by the United States Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP) and the participating organization’s institutional review board (IRB).
Can anyone participate in a clinical trial?
Contrary to popular conception, clinical trials are not a last resort for patients. Rather, clinical trials are conducted wherever there is a need for better/less toxic therapies.
What are the risks of participating in a clinical trial?
Just like standard therapies, study interventions may not work in everyone and may result in adverse effects. These risks may be similar to standard therapies or may be completely different. Additional risks may include extra testing or clinical visits, increased costs, or loss of confidentiality. Specific risks are discussed with participants during the informed consent process. However, there may be risks that are not yet known, and new information that is learned during the trial is often communicated with study participants.
What kind of time commitment does a clinical trial involve?
The length of a clinical trial varies depending on the nature of the study. In addition, some trials require a greater investment of time than standard therapies. These details are discussed during the informed consent process.
How is patient confidentiality protected?
Since personal health information is collected, there is the risk of a loss of confidentiality. No personal health information is used/disclosed unless agreed to by the study participant. Participants are not identified personally in any reports or publications resulting from any research study. Medical records of study participants are stored according to legal requirements and are only available to personnel associated with the research study.
Where can I find open clinical trials ?
Click here for a listing of lymphoma trials open at Weill Cornell Medicine and NewYork-Presbyterian Hospital.