Here at North Shore-LIJ's Health System, many of the new treatments and advances in cancer research have been rendered through the use of clinical trials. Clinical trials are studies used to evaluate new cancer treatments and detection, and are sometimes referred to as research protocols or clinical studies. They are conducted by doctors and other health care professionals and are often used to determine which drugs and procedures are safe and effective. However, before a clinical trial is staged for a particular treatment or drug, it has been tested for safety through animal and laboratory studies.
Clinical Trials FAQ
1) What are some types of clinical trials?
- Prevention trials designed to study the prevention of cancer in those people who have never had cancer.
- Prevention trials designed to study the prevention of new cancers in people who have had cancer.
- Early detection trials used to study techniques in the detection of cancer, especially in its early stages.
- Treatment trials used to test new therapies in people with cancer.
- Quality of life studies designed to study techniques to improve comfort and quality of life.
- Behavioral studies used for evaluating cancer-causing behaviors such as tobacco use, and determine ways to modify them.
2) What are the phases of a clinical trial?
- Phase I trials evaluate how a new therapy should be administered. The focus is on safety for the next phase of testing.
- Phase II trials provide preliminary information about how well the new therapy works.
- Phase III trials compare a promising new therapy, combination of treatments or procedure with a current standard of treatment.
- Phase IV trials include the continuing evaluation that takes place after FDA approval, when the therapy is already available for general use.
3) How are clinical trial participants protected?
- There are several procedures in place, as part of the protocols, to protect the safety of the participants. The organization that sponsors the study as well as the Institutional Review Board (IRB) that manages clinical research in the healthcare institution, oversees the trials. The IRB includes physicians, other healthcare providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study.
4) Where are clinical trials conducted?
- Clinical trials are normally conducted in cancer centers, university hospitals, local medical centers or physicians’ offices.
5) Why should I take part in a clinical trial?
- You may be the first to benefit from a successful drug or treatment.
- You may be able to help cancer patients in the future.
- The sponsor of your trial may pay for all or part of your ancillary expenses.
6) Who should take part in a clinical trial?
- Clinical trials have guidelines about participants, which include medical or other conditions that must be met. In addition, each protocol (or guideline) defines specific eligibility criteria including age, race, ethnicity, gender and general health.