The safe and effective conduct of clinical trials is one of the most fundamental goals for every faculty member within the Department of Hematology and Medical Oncology. The basis of all clinical trials, is the delivery of the highest level of clinical care, and through clinical trials, patients have access to the latest and most innovative treatment options. Many of the clincial trials conducted by faculty in the department are trials that were written by our faculty, and those trials represent a significant committment of institutional resources for their conduct. It is also important to realize that clinical trials are not reserved for patients at the 'end stage' of their disease. Each disease group in our department has trials for patients at every phase of their care, whether they are recently diagnosed, or have relapsed disease. It is also possible that the trial may not involve a different treatment. There are tissue collection trials where patietns agree to give a sample of their tumor tissue for future study, In these trials, we will often ask for access to what happens to you as a patient, so if new markers are identified, we can use these markers to better understand how a marker correlates with the clinical course a patient is experiencing.
Types of clinical trials:
There are 3 different groups of clincial trials which are described in phases of development. Phase I clinical trials are geared towards early experience with a new drug, or a novel combination of 2 different drugs where the dosing for the combination is not well described. Phase i trials are geared towards identifying a safe dose for a given drug or combination, though it is importnat to realize that very often patients can have good and durable responses in the context of phase I clinical trials. At the Winship Cancer Institute, phase I clinical trials are conducted within the phase 1 unit within the ambulatory treatment center.
Phase 2 clincial trials are designed to test the actual effectiveness of a given treatment once the dose has been established. Phase 2 clinical trial can vary in size from 15 to 100 patients depending on how they are being evaluated Typically the main goal is to prove that a given treatment works, though safety is always a consideration in any clinical trial.
Phase 3 clinical trials are trials that are focused on formally comparing a new treatment against a standard treatment with the goal of replacing the older treatment with the new one. While this is the goal, it is not always the case that the new treatment is better, and thus this phase is critially important in defining the real benefit for a new treatment. Typically patients are randomized in phase III trials, that is, which trreatmet a patient will receive is determined by a flip of a coin. this is done to avoid any type of bias in interpreting the results. Phase 3 trials are usually watched closely as they are often used by agencies such as the FDA to determine in a new drug is allowed to be approved for general use.
All trials function with very strict oversight from internal and external agencies. Clincial trials are approved by Winship based scientific review, as well as Emory based Internal Review Board (IRB), as well as by sponsors or the NCI. There are often more individuals watching the care of a patient on a trial as there are study personal who are focused on collecting information, response, and side effects from patients while they are on the study. It is these extra eyes that provide not only additional oversight, but also additional safety for patients while they are on clinical trials.
Clinical trials are an important part of making progress in medicine overall, and specifically in oncology. Access to new agents and cutting edge clincial trials is one of the most important missions for faculty in the department of Hematology and Medical Oncology. It is important patients feel free to ask questions about the trials being proposed, and that these questions are fully answered before patients sign consent forms, or begin therapy. Please be sure to ask about clincial trials no matter where you are in your treatment course so that we can provide the highest level of quality and innovative care.