**2. Problems of the past**

The primary mechanism for oncology clinical development over the past 50 years has been in the planning and execution of clinical trials. The oncology clinical trial program in the National Cancer Institute (NCI) began as small groups of clinical investigators driven by the common need to potentially improve the care of subjects undergoing cancer therapy. The groups quickly grew into larger organizations of adult and pediatric oncologists, which included representation from all oncology disciplines in surgery, medical oncology, and radiation therapy. By 1980, pediatrics was recognized as its own discipline and the Pediatric Oncology Group (POG) was established by the merger of the pediatric divisions of the former Cancer and Leukemia Group B (CALGB) and SWOG. In 1995, imaging was recognized as its own discipline and the American College of Radiology Imaging Network (ACRIN) was established to meet the growing need of imaging acquisition and imaging science in clinical trials. Although each of the established groups housed radiation oncology as a discipline committee, the Radiation Therapy Oncology Group (RTOG) was established to promote radiation oncology as a discipline with a pathway to evaluate radiation technology and comprehensive radiation therapy. In its halcyon moment, there were 10 cooperative groups each with its own statistical data center and tissue bank resource center. The cooperative groups have been responsible for generating many of the most important publications on oncology care over the past 60 years and have become the model for validating progress in oncology. Core services in imaging and radiation therapy were established to manage specified needs in cooperative group clinical trial management. These included the Radiological Physics Center (RPC) and the Quality Assurance Review Center (QARC) as well as the American College of Radiology (ACR). As radiation oncology matured into an image-directed discipline, the radiation oncology quality assurance centers assumed a greater responsibility into collecting images used to develop target volumes of choice for radiation therapy treatment planning. In pediatrics, the images were not siloed as segregate entities between radiology and radiation therapy but applied symbiotically to all investigators for target definition and assessment of response in a single data review system. This enhanced the synergism between radiologists and radiation oncologists in the care of children [1]. In 2007, a recommendation was made by a group designed to review and assess the cooperative group mechanism and functions. The recommendation was to decrease the number of the individual cooperative groups and consolidate core services including tissue banks, data management centers, and process review of quality assurance [2]. The pediatric groups had merged into the Children's Oncology Group (COG) and as the restructuring started to mature, COG was positioned to be one of the five funded groups. The transition was completed by 2014. SWOG (formerly South West Oncology Group) chose to remain a single entity. The National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG) merged as an administrative entity now known as NRG Oncology. The Cancer and Leukemia Group B (CALGB), American College of Surgeons Oncology Group (ACOSOG), and the North Central Cancer Treatment Group (NCCTG) formed the Alliance for Clinical Trials in Oncology and the Eastern Cooperative Oncology Group (ECOG) merged with the American College of Radiology Imaging Network (ACRIN) to form the ECOG-ACRIN Cancer Research Group. Each of the groups maintains an operation center as well as a statistical and data management center with NRG having more than one center. Tissue banking overlaps between the groups. The image acquisition and management and radiation therapy quality assurance are managed by the Imaging and Radiation Oncology Core (IROC), which was constituted by the existing imaging and radiation therapy quality assurance centers. These centers include the Radiologic Physics Center (RPC), the Quality Assurance Review Center (QARC), the Wright Imaging Center at Ohio State,

**175**

*Acquisition and Management of Data for Translational Science in Oncology*

and the American College of Radiology (ACR) core quality assurance centers in imag-

The integration of the cooperative groups established an economy of scale for the NCI clinical trials program. The five NCTN groups house a significant amount of data. These data include outcome data, tissue banks data, and IROC hosting invaluable information important for clinical trial outcome analysis. These data libraries house the largest volume of oncology-related information in the world. Because the data are acquired on clinical trials, the datasets and outcome information are the best in the world for consistency in data acquisition and management and completeness of the information. They are among the best resources in the world for performing outstanding translational science research and comparing institutional translational science against validated datasets. Currently, the data are fragmented and siloed within the multiple remaining statistical centers, tissue banks, and IROC. Moving salient trial information into a single or synergistic data system would be an important objective promoting translational science. Hundreds of thousands of complete datasets are readily available in these systems, which can be used to promote individual work and serve to validate work of translational scientists for the next generation of clinical trials. This is the goal of big data acquisition and data management of this information. Each subject on study has pathology, imaging, therapy, and data for outcome analysis. Validated datasets with consistent and uniform acquisition of information will permit accurate assessment of trial outcome and provide quantitative significance to the work. The potential for successful application of this effort is within our reach, the challenge is to define a pathway to achieve the goals of the work. Problem solving in oncology is challenging. To move the field forward with strong translational science and apply balanced judgments for disease management, the information acquired for review must be robust to appropriately power the study question and have the quality needed to be certain that the conclusions are accurate and can be validated. Oncology data management can be challenging if the information under review is incomplete and unvalidated, resulting in inaccurate conclusions established in outcome analysis. The database must also undergo self-renewal as process improvements become standard for evaluating outcome imaging to validate patterns of failure and pathology to review change in biomarker status relative to disease progression. Tools for biomarker identification, imaging, radiation oncology, and applied medical oncology are under constant revision and databases for translational science need constant maintenance to insure accuracy and applicability. Future strategic translational science objectives are clear and unambiguous. The more complete and accurate the information acquired, the more successful science can be applied to the bedside. In the next section, we will describe challenges in clinical trial outcome interpretation when information is incomplete.

*DOI: http://dx.doi.org/10.5772/intechopen.89700*

**3. Problems in clinical trial interpretation**

Hodgkin lymphoma is a unique disease than can affect children, adolescents, and adults of all ages. Chemotherapy has become the initial and primary therapy for this disease with choice of agents and duration of therapy based on stage at presentation, subject medical status, and response to induction therapy. The use of radiation therapy remains under continued refinement and influenced by both response to chemotherapy and volume of tumor at presentation. Pediatric Oncology Group protocol 8725 evaluated what would be today called intermediate and advanced stage subjects.

In this study, subjects were treated with eight cycles of hybrid chemotherapy

**3.1 Hodgkin lymphoma**

ing and radiation oncology [1, 3].

#### *Acquisition and Management of Data for Translational Science in Oncology DOI: http://dx.doi.org/10.5772/intechopen.89700*

*Translational Research in Cancer*

**2. Problems of the past**

The primary mechanism for oncology clinical development over the past 50 years has been in the planning and execution of clinical trials. The oncology clinical trial program in the National Cancer Institute (NCI) began as small groups of clinical investigators driven by the common need to potentially improve the care of subjects undergoing cancer therapy. The groups quickly grew into larger organizations of adult and pediatric oncologists, which included representation from all oncology disciplines in surgery, medical oncology, and radiation therapy. By 1980, pediatrics was recognized as its own discipline and the Pediatric Oncology Group (POG) was established by the merger of the pediatric divisions of the former Cancer and Leukemia Group B (CALGB) and SWOG. In 1995, imaging was recognized as its own discipline and the American College of Radiology Imaging Network (ACRIN) was established to meet the growing need of imaging acquisition and imaging science in clinical trials. Although each of the established groups housed radiation oncology as a discipline committee, the Radiation Therapy Oncology Group (RTOG) was established to promote radiation oncology as a discipline with a pathway to evaluate radiation technology and comprehensive radiation therapy. In its halcyon moment, there were 10 cooperative groups each with its own statistical data center and tissue bank resource center. The cooperative groups have been responsible for generating many of the most important publications on oncology care over the past 60 years and have become the model for validating progress in oncology. Core services in imaging and radiation therapy were established to manage specified needs in cooperative group clinical trial management. These included the Radiological Physics Center (RPC) and the Quality Assurance Review Center (QARC) as well as the American College of Radiology (ACR). As radiation oncology matured into an image-directed discipline, the radiation oncology quality assurance centers assumed a greater responsibility into collecting images used to develop target volumes of choice for radiation therapy treatment planning. In pediatrics, the images were not siloed as segregate entities between radiology and radiation therapy but applied symbiotically to all investigators for target definition and assessment of response in a single data review system. This enhanced the synergism between radiologists and radiation oncologists in the care of children [1]. In 2007, a recommendation was made by a group designed to review and assess the cooperative group mechanism and functions. The recommendation was to decrease the number of the individual cooperative groups and consolidate core services including tissue banks, data management centers, and process review of quality assurance [2]. The pediatric groups had merged into the Children's Oncology Group (COG) and as the restructuring started to mature, COG was positioned to be one of the five funded groups. The transition was completed by 2014. SWOG (formerly South West Oncology Group) chose to remain a single entity. The National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG) merged as an administrative entity now known as NRG Oncology. The Cancer and Leukemia Group B (CALGB), American College of Surgeons Oncology Group (ACOSOG), and the North Central Cancer Treatment Group (NCCTG) formed the Alliance for Clinical Trials in Oncology and the Eastern Cooperative Oncology Group (ECOG) merged with the American College of Radiology Imaging Network (ACRIN) to form the ECOG-ACRIN Cancer Research Group. Each of the groups maintains an operation center as well as a statistical and data management center with NRG having more than one center. Tissue banking overlaps between the groups. The image acquisition and management and radiation therapy quality assurance are managed by the Imaging and Radiation Oncology Core (IROC), which was constituted by the existing imaging and radiation therapy quality assurance centers. These centers include the Radiologic Physics Center (RPC), the Quality Assurance Review Center (QARC), the Wright Imaging Center at Ohio State,

**174**

and the American College of Radiology (ACR) core quality assurance centers in imaging and radiation oncology [1, 3].

The integration of the cooperative groups established an economy of scale for the NCI clinical trials program. The five NCTN groups house a significant amount of data. These data include outcome data, tissue banks data, and IROC hosting invaluable information important for clinical trial outcome analysis. These data libraries house the largest volume of oncology-related information in the world. Because the data are acquired on clinical trials, the datasets and outcome information are the best in the world for consistency in data acquisition and management and completeness of the information. They are among the best resources in the world for performing outstanding translational science research and comparing institutional translational science against validated datasets. Currently, the data are fragmented and siloed within the multiple remaining statistical centers, tissue banks, and IROC. Moving salient trial information into a single or synergistic data system would be an important objective promoting translational science. Hundreds of thousands of complete datasets are readily available in these systems, which can be used to promote individual work and serve to validate work of translational scientists for the next generation of clinical trials. This is the goal of big data acquisition and data management of this information. Each subject on study has pathology, imaging, therapy, and data for outcome analysis. Validated datasets with consistent and uniform acquisition of information will permit accurate assessment of trial outcome and provide quantitative significance to the work. The potential for successful application of this effort is within our reach, the challenge is to define a pathway to achieve the goals of the work.

Problem solving in oncology is challenging. To move the field forward with strong translational science and apply balanced judgments for disease management, the information acquired for review must be robust to appropriately power the study question and have the quality needed to be certain that the conclusions are accurate and can be validated. Oncology data management can be challenging if the information under review is incomplete and unvalidated, resulting in inaccurate conclusions established in outcome analysis. The database must also undergo self-renewal as process improvements become standard for evaluating outcome imaging to validate patterns of failure and pathology to review change in biomarker status relative to disease progression. Tools for biomarker identification, imaging, radiation oncology, and applied medical oncology are under constant revision and databases for translational science need constant maintenance to insure accuracy and applicability. Future strategic translational science objectives are clear and unambiguous. The more complete and accurate the information acquired, the more successful science can be applied to the bedside. In the next section, we will describe challenges in clinical trial outcome interpretation when information is incomplete.
