What Are Clinical Trials?
Clinical trials are research programs which utilize patients to evaluate potential new medical treatments. Clinical trials are vital to the development of new drugs and other new treatments.
After concepts for new treatments are developed in a research laboratory, those with the greatest potential for effectiveness are first tried on a small group of people and then further studied in a larger clinical trial. Clinical trials take the latest innovations on the scientific frontier and apply them to patient care. During the clinical trial the treatment being evaluated is compared to a standard. The standard is the best treatment which is currently available.
The greatest anticipation and hope for a new treatment begins when it is tried on humans. The safety and effectiveness of the treatment along with the possibility of side effects and risks are what is studied. Four phases of clinical trials exist and each phase is used to ferret out purposeful information.
- Phase I these clinical trials involve giving the treatment being studied to a small number of trial participants. Researchers decide how to administer the treatment and how much is safe to administer.
- Phase II these clinical trials study the effect of the treatment on a specific disease or condition.
- Phase III during these clinical trials the new treatment is compared to the standard treatment.
- Phase IV these clinical trials serve to apply the new treatment to the patient's treatment plan, for example, by using it in combination with other effective drugs.
Clinical Trials: How to Get Involved
How does someone interested in becoming a clinical trial participant become involved? Participants in clinical trials are volunteers. A person expressing an interest in becoming a volunteer is made aware of the possible benefits and risks and asked to sign an informed consent by those conducting the study. The informed consent is not binding. The volunteer is able to leave the trial before completion if they so desire. New information may also be offered as the trial progresses which could affect their inclination to continue in the study.
To enroll in a particular study, a patient must possess certain symptoms and have a specific condition. One advantage of enrolling is that the patient is able to try a new treatment sooner than the general public. Another advantage is that treatment cost can be lessened since some costs are paid for by the study. According to "Clinical Trials: A Guide For Patients", Cleveland Clinic, if a person is contemplating becoming a trial participant they should first obtain answers to the following questions:
- For what purpose is the clinical trial being conducted?
- What tests and treatments will be given during the trial?
- In my case, what is expected to happen with or without the new treatment?
- How does the standard treatment compare to the new treatment?
- What impact will the trial have on my daily life?
- Are there any expected side effects from the treatment?
- What is the duration of the clinical trial?
- Will the trial require me to invest extra time?
- Will the trial require me to be hospitalized?
- What will happen if I withdraw from the trial?
How to Find Clinical Trials
Several websites list ongoing clinical trials:
- Centerwatch is a listing service for clinical trials designed as a resource for those interested in participating.
- National Institutes of Health Clinical Center also has a searchable listing of studies being conducted.
- The National Databank for Rheumatic Diseases is a research databank for the study of arthritis and rheumatic conditions. If you have been diagnosed with one or more rheumatic diseases you are eligible to participate in their research.
Clinical Trials: A Guide For Patients, Cleveland Clinic