Types of Clinical Trials
- Adjuvant Therapy Trials
Adjuvant clinical trials are designed to test ways of preventing a recurrence in those who have been successfully treated by surgery, radiation, chemotherapy or any other means. This type of trial is intended for those who have no clinical signs of disease and are intended to prolong disease free survival.
- Neo-Adjuvant Therapy Trials
Neo-adjuvant treatment is administered prior to standard therapy in order to reduce the tumor to the point where it may be effectively treated. Neo-adjuvant trials are designed to test to see if giving a specific treatment (chemo or radiation) before surgery will improve a patient's surgical options. (For example, a neoadjuvant trial might test to see if a new chemo will shrink tumors to the point where surgery might be possible or more effective, or might test to see if radiation prior to surgery would decrease the likeliness of a colostomy).
- Surgical Intervention Trials
Surgical techniques, like other treatment options, must be demonstrated to be scientifically effective. New surgical techniques are tested through the clinical trials system. There are no Phase I surgical trials, however, because there is no need to determine a safe dose level, as with a drug. Surgical clinical trials are used to determine the ideal extent of surgery and the timing of the surgery in the context of the entire treatment of the patient.
- Supportive Care Trials
Supportive care clinical trials test new options for dealing with the side effects of the cancer itself and the treatment for the cancer. These options might include medicines to address side effects from chemo, nutritional interventions, and psychosocial options such as support groups or one-on-one support. These trials may be aimed at the patients or in some cases may be trials for families or caregivers to help them cope with the disease.
- Prevention Trials
Prevention trials look at individuals who are at high risk of developing the disease, and test interventions that might reduce their risk of developing cancer. These interventions might include drugs (chemoprevention trials) or lifestyle changes. Usually people in these trials are split into two groups, and one group gets the "intervention being studied" while the other group does not. People in these studies are often followed for several years to determine the long term effects on prevention.
- Early Detection Trials
In early detection clinical trials, the researchers want to determine the best method and frequency to screen a normal group of people. Prevention studies are generally aimed at those who are at high risk of developing cancer or less commonly those in the population at large to assess screening techniques. They may target age groups, socioeconomic strata, or combinations of risk factors. Patients participating in these trials must not have had cancer or currently have cancer but will likely have had one or more first degree relatives with a cancer or a family history of multiple cancers.