Patient InformationResearchWhat are clinical trials?Clinical trials are research studies in which people help find new ways to improve health and health care. Many of the cancer treatments in use today are based on the results of past clinical trials. Clinical trials are conducted in an orderly, carefully designed manner. After laboratory and animal research is complete, several phases in humans help to answers questions such as:
What are the phases of clinical trials?Generally, clinical trials have four phases. The first phase only begins after a so-called “pre-clinical” phase of laboratory research that may take years. Only then does a clinical trial involving patients begin. Phase 1: In this initial phase, researchers study a new drug or treatment in a small group of people (often healthy volunteers). The focus is safety. Investigators attempt to determine a safe dose for new drugs, effectiveness and side effects. Phase 2: In this phase, investigators study the safety and effectiveness of the drug or treatment in a larger group of people. In this phase, the subjects are often people with the disease that the drug is designed to treat. Phase 3: In a Phase 3 study, the number of subjects is expanded to several hundred to several thousand subjects and often takes several years to complete. The goal of this phase is to provide the pharmaceutical company or device manufacturer and the Federal Drug Administration (FDA) with a more complete understanding of all aspects of the drug-effectiveness, appropriate dose, risks and side effects (in the case of drugs) or efficacy, safety and risks (in the case of a device or procedure). Phase 3 trials usually involve several centers and participants are generally a population for whom the drug or device is eventually intended. Phase 4: Phase 4 trials are conducted following introduction of the drug or device to market and provide additional information regarding use, benefits, effectiveness compared to treatments on the market, side effects not previously identified and other factors. How can I participate in a clinical trial?Clinical trials have very specific guidelines that define eligibility. These guidelines are designed to ensure rigorous evaluation of the drug, device or procedure and to avoid putting patients at unnecessary risk. Not all patients with a particular disease will be eligible to participate in clinical trials intended to help treat or cure that disease. Participation in clinical trials is always voluntary. However, participation for those who meet the eligibility criteria may have access to new treatments before they are widely available or may allow you to benefit others by allowing you to contribute to medical research. Declining to participate in a clinical trial will in no way affect the quality of your care. What clinical studies in thoracic oncology are ongoing at Boston Medical Center?For more information on thoracic oncology clinical trials at Boston Medical Center, visit the Cancer Research Center site hosted by Boston University School of Medicine. More information about BMC’s Center for Thoracic Oncology is available at http://www.bostonthoracicsurgery.com/
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