About this Research Topic
Clinical trials remain the primary vehicle to improve the care of the oncology patient and establish standards of care in all oncology disease sites. To move the endpoints of clinical trials into the workflow of current patient management, study investigators and primary caregivers need to trust both the data and the study outcome. Trust in study outcome is established when investigators and clinical care providers have confidence in the quality of the clinical trial data acquisition process and management with validation of the data. All elements of modern patient care need to be imbedded in the clinical trial process and each component including imaging, pathology, radiation therapy treatment objects, surgical/medical oncology care data must be made available to study investigators and regulatory agencies to affirm and validate trial outcome in order to generate confidence in the data and study outcome. The National Clinical Trials Network (NCTN) has managed clinical trials in oncology for six decades. As the trials have matured to ask modern questions, the process of quality assurance imbedded in each specific trial likewise has improved to meet modern demands of real time review of data to ensure treatment compliance to study prior to initiation of therapy. Digital tools have matured to permit site and study investigators to review objects together in real time in order to ensure that the patient is placed into the correct trial and the planned treatment is study compliant. There are many examples where insufficient information and deviations from protocol care have influenced study outcome, and the goal of the quality assurance process is to limit deviations, create a more uniform study population, and generate confidence in study outcome.
The goal of this Research Topic is to describe the modern process of clinical trial quality assurance and how the discipline involved in quality assurance influences clinical trials in all oncology related disease areas. Each clinical area has individualized needs in quality assurance, nevertheless similar principles of the quality assurance process cross disease sites. Each oncology disease area has knowledge experts imbedded on disease committees and these leaders will describe how the quality assurance process is imbedded in clinical trials and how data from the trials can influence the primary objectives of the study and likewise be re-purposed to answer secondary questions not anticipated at the time of trial design.
The Research Topic will have three major points of emphasis; Leaders in the quality assurance of clinical trials will review how the quality assurance process is applied in each trial, including validation of data acquisition and management of the information. Clinical trial leaders will also emphasize specific data management and quality assurance need for their specific disease discipline. Finally, the future vision for clinical trial data management, which will include sections on needs for globalization for clinical trials and preparation of data for use by national data archives, will also be examined.
The goal of this Research Topic is to describe the modern process of clinical trial quality assurance and how the discipline involved in quality assurance influences clinical trials in all oncology related disease areas. Each clinical area has individualized needs in quality assurance, nevertheless similar principles of the quality assurance process cross disease sites. Each oncology disease area has knowledge experts imbedded on disease committees and these leaders will describe how the quality assurance process is imbedded in clinical trials and how data from the trials can influence the primary objectives of the study and likewise be re-purposed to answer secondary questions not anticipated at the time of trial design.
The Research Topic will have three major points of emphasis; Leaders in the quality assurance of clinical trials will review how the quality assurance process is applied in each trial, including validation of data acquisition and management of the information. Clinical trial leaders will also emphasize specific data management and quality assurance need for their specific disease discipline. Finally, the future vision for clinical trial data management, which will include sections on needs for globalization for clinical trials and preparation of data for use by national data archives, will also be examined.
Keywords: clinical trials, quality assurance, radiation oncology, data acquisition, globalization, national data archives, National Clinical Trials Network
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