Clinical Research is a key component of our mission here at the Provision Center for Proton Therapy and serves as an integral part of all major comprehensive cancer programs. Without clinical research, we would not have the vast majority of successful treatments available to cancer patients today.
Often there is confusion between the terms Clinical Research, Clinical Studies, and Clinical Trials. Clinical Research is a broad term that includes Pre-Clinical Research and Translational Research. Pre-Clinical Research most often consists of research initially performed in the laboratory that may include animal or human cell lines to test the effectiveness of new therapeutic agents, devices, or procedures. If this research demonstrates promise, then the research most often moves into the Translational Research phase where it is best determined how to “translate” the pre-clinical research into research in human subjects. This usually results in the development of Clinical Trials.
Clinical Studies involves research in human subjects to improve medical knowledge as defined by the National Institutes of Health. Clinical Studies can be divided into two distinct categories. Clinical Trials and Observational Studies. A Clinical Trial is developed to determine if new therapeutic agents (chemotherapy, monoclonal antibodies), devices (proton therapy, brachytherapy), or procedures (surgery) are effective or better in comparison to other current standard treatments in humans. Clinical Trials are often broken down into (4) four phases in order to answer different research questions as noted in the table below.*
Once a new agent, device, or procedure is deemed successful in Phase 3 trials it is then approved by the FDA for use in the general population.
Observational Studies or Registries are very basic clinical studies where data is collected from groups of participants according to a predefined research or protocol plan. This data is collected from treatments and follow-up visits in order to observe long-term effectiveness or side effects. This can often include quality-of-life surveys that are completed by the participants at different time intervals after their treatments are complete.
Offering the most advanced cancer treatments available is part of our mission here at Provision, and thus Clinical Research is an important aspect of the care we provide. We offer many innovative clinical and registry trials for our patients to participate in if desired. Performing this research allows us and our patients to work together to save more lives.
Scott Warwick is Vice President of Program Development & Strategic Initiatives
For more information on the Provision Center for Proton Therapy, visit the web site at www.provisionproton.com or call (865) 862-1600