The cooperative group administrative structures matured as trials became more complex.
Fran laurie qarc full#
Although reimbursement did not cover full trial costs, finances from clinical trials were used to promote and facilitate participation in the clinical trials process. Financial incentives for trial participation provided the management infrastructure for the institutional trial offices.
Clinical faculty functioned as clinical trial investigators and trial participation became important and influential in institution promotion processes. Participation in clinical trials enhanced the public perception of both large and small institutions as participation suggested that the oncology skill set of the treatment program functioned at a high level. Only multi-institution trials, with large study populations, could validate the role of new systemic chemotherapy strategies including dose and dose scheduling in a timely manner. The development and maturation of systemic therapy extensively influenced the importance and status of cooperative group clinical trials. Over time, the concept of multi-institution clinical trial strategies matured into successful federally funded programs. Pre-conceived beliefs in treatment standards coupled with institution bias often limited successful uniform clinical trial execution. As cancer therapy became more universally available in the mid-twentieth century, oncology specialists began discussing standards of care and how these standards could be applied in a multi-institution cooperative group format. In the past 50 years, the National Cancer Institute (NCI) Clinical Trials Cooperative Group Program has generated an extraordinary legacy of ground breaking clinical and translational science significantly influencing the standard care for oncology patients. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This information needs to be made available to investigators using digital processes for real-time data analysis. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy, and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based process improvements for clinical oncology patient care. 12Department of Radiology, Columbia University, New York, NY, USA.11Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
7Radiation Therapy Oncology Group, Philadelphia, PA, USA.6Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA.5Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.4Department of Radiation Oncology, Emory University School of Medicine, Atlanta, GA, USA.3Department of Radiation Oncology, Washington University School of Medicine, St.2Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA, USA.1Quality Assurance Review Center, Lincoln, RI, USA.Schnall 11, Lawrence Schwartz 12, Kenneth Ulin 1,2, Ying Xiao 6,7 and Marcia Urie 1 Knopp 9, Fran Laurie 1, Elizabeth O'Meara 7, Jeff M. FitzGerald 1,2*, Maryann Bishop-Jodoin 1, Walter R.
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