Dr. Paul Sabbatini, a medical oncologist at Memorial Sloan Kettering Cancer Center, describes the extensive groundwork that goes into preparing a clinical trial long before it is offered to patients. Doing preclinical laboratory or animal studies allows researchers to understand the many ways in which an investigational drug might be effective.
Once a clinical trial begins, it may be offered to a broad range of patients at multiple clinical sites. By performing intensive patient follow-up during the early part of a clinical trial, investigators ensure the safety of the investigational therapy while looking for evidence of its effectiveness. According to Dr. Sabbatini, this approach represents a paradigm shift in clinical research.