The Yuma Regional Clinical Research Program invites you to call with any questions you may have. You may reach us at 928-336-3366.
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.
These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making and many treatments and medications used today are the results of past clinical trials.
Clinical trials have led to scientific advances that have increased doctors' understanding of disease.
This knowledge has helped doctors make progress in preventing disease, diagnosing disease, slowing, stopping or controlling the development of a disease. Because clinical trials may involve hundreds or even thousands of people, it often takes a long time to find out the results. Still, clinical trials remain the most reliable and only accepted scientific method to find out if a new treatment works better than the current standard of care.
The purpose of clinical trials is research, so the studies follow strict scientific standards.
These standards protect patients and help produce reliable study results. Regulations at both national and international levels are in place to protect the safety and well-being of patients and to ensure trials are conducted to strict, ethical and scientific principles.
Clinical trials are one of the final stages of a long and careful research process.
The process often begins in a laboratory, where scientists first develop and test new ideas. If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people so human participation is needed.
For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm.
In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. A clinical trial may find that a new strategy, treatment, or device improves patient outcomes; offers no benefit; or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.
Each clinical trial follows a set of rules called a protocol.
A protocol describes inclusion and exclusion criteria; the schedule of tests, procedures, medications, and doses; and the length of the study.
All clinical trials have requirements about who can join, called inclusion and exclusion criteria.
Examples of the criteria are a person's age, type of disease, medical history, and current health.
Inclusion criteria help make sure that all the people in the clinical trial are medically similar.
For example, the inclusion criteria may require that each participant have the same type of disease or the same stage of disease. If the people have too many medical differences, the doctors will have more difficulty interpreting the results.
Likewise, exclusion criteria help keep people safe.
For example, it is often not safe for patients with a severe heart condition or kidney failure to receive certain treatments, so they may be excluded from some clinical trials. Exclusion criteria are not used to reject people personally but to protect people from potential risks and increase what doctors and researchers can learn from each study.
While a person is participating in a clinical trial and often for a time after the treatment has ended, the research team monitors the health of the participants to determine the safety and effectiveness of the treatment.
The research team includes doctors, nurses, social workers, and other health care professionals. They will check the person’s health at the beginning of the clinical trial, give specific instructions for participating in the clinical trial, monitor the person carefully during the clinical trial, and stay in touch with the person after the study. A person's participation will be most successful if they carefully follow the instructions given to them by the research team and stay in contact with the research staff.