What is a Clinical Trial?

DoctorClinical trials are research studies designed to improve treatment for patients. Some trials investigate new drugs and treatments while others compare standard treatments against new treatments. Before a new treatment is offered to a patient in a clinical trial, it is carefully studied in the laboratory. All our current standard cancer therapies were once experimental research therapies evaluated in clinical trials. Only after clinical trials show one treatment to be superior can that therapy become a new standard treatment. All treatment advances must pass through clinical trial evaluation.

Clincal trials fall into 4 Phases:
Phase I- Experimental treatments are evaluated to determine the best dosage and evaluate for side effects. Many treatments do not progress past phase I.
Phase 2*- Once dosage and side effects are known, trials are conducted to get an idea if the new treatment has beneficial effect (a response rate) in a certain disease. More toxicity information is learned.
Phase 3*- The new therapy is compared to the current standard therapy in a randomized trial to see which therapy is better.
Phase 4- After a therapy or drug is approved and felt to be a standard therapy, many more cases are reviewed in order to detect uncommon side effects or outcomes.

*Kaiser Permanente Colorado primarily participates in phase 2 and 3 clinical trials.