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Introduction: There is an increased need to monitor and intervene to assist breast cancer (BC) survivors overcome the long-term and late effects of treatment. Many institutions are moving toward computerized assessments (CA) of PROs such as symptoms and concerns in place of more traditional paper and pencil administration, but little work has been performed to demonstrate that these very different methods of administration produce comparable results. Our goal was to evaluate the outcomes produced by these methods by comparing two similar samples of breast cancer survivors, one of which completed a PROs assessment using paper and pencil (PP), the other of which was assessed using a computerized system that links to the patient portal in use at our facility. Data collection of the CA of PROs is ongoing. Method: Women were eligible if they had a confirmed diagnosis of Stage 0-III BC, were within one year of completion of primary therapy, and were scheduled for a survivorship-focused end of treatment visit. As this was a naturalistic cohort study, no randomization was undertaken. The PRO assessment covered 19 common long-term or late effects of treatment, inquiring about their occurrence and severity in the previous month. On the day of the visit, participants in the PP cohort were provided with the questionnaire packet to complete prior to meeting with their provider. The women who completed the CA were either already enrolled in the patient portal or enrolled at the time of recruitment and sent an online version of the same questionnaire. Reminder calls and/or emails were sent to the CA participants to improve compliance. Results: 164 BC survivors completed the PP questionnaire, and 62 women completed the CA. Racial make-up, marital status, and education, were similar between groups. Women in the PP group were older than those in the CA group (55.45 vs. 51.23 yrs, p < 0/05) and those in the PP group were marginally more likely than those in the CA group to have been menopausal prior to treatment (50% vs. 35%, p = 0.05). With respect to PROs, there were no significant differences between groups in either the proportion of women endorsing a given symptom/concern or in the mean severity rating for any symptom/concern. The five most commonly reported concerns did differ somewhat between groups, with PP reporting Fatigue, Insomnia, Hot Flashes, Aching Joints, and Memory Difficulties, respectively, and CA reporting Fatigue, Anxiety, Body Image Problems, Memory Difficulties, and a tie between Insomnia and Depression, respectively. Conclusion: The results of the PRO assessment can be assumed to be comparable whether the method of administration is either PP or computerized. Differences found between groups in the most commonly endorsed symptoms likely reflected differences in age and menopausal status. Citation Format: Palmer SC, DeMichele A, Glanz K, Schapira M, Pucci DA, Blauch AN, Jacobs LA. Comparability of computerized and paper-pencil patient reported outcome (PRO) assessments – Does it matter how they are administered?. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-10-11.

Over the past 10 years, the Tumor Microenvironment Network (TMEN), supported by the NCI (Bethesda, MD), has promoted collaborative research with the explicit goal of fostering multi-institutional and transdisciplinary groups that are capable of addressing complex issues involving the tumor microenvironment. The main goal of the TMEN was to generate novel information about the dynamic complexity of tumor-host interactions in different organ systems with emphasis on using human tissues and supplemented by experimental models. As this initiative comes to a close, members of the TMEN took time to examine what has been accomplished by the Network and importantly to identify the challenges and opportunities ahead. This consensus document summarizes for the broader scientific community discussions that occurred at the two final meetings of the TMEN in 2015 and 2016. Cancer Res; 77(5); 1051-9. ©2017 AACR ., (©2017 American Association for Cancer Research.)

The lack of reproducibility of preclinical research is a significant and growing problem which slows basic research and leads to fruitless clinical trials. An increasing number of reports have found discrepancies in published preclinical studies across scientific disciplines. For example: * Amgen found that 47 of 53 “landmark” oncology publications could not be reproduced. * Bayer found that their internal results contradicted academic publications in 43 of 67 oncology and cardiovascular projects. * Dr. John Ioannidis and his colleagues found that of 432 publications purporting sex differences in hypertension, multiple sclerosis, or lung cancer, only one data set was reproducible. These studies, and the many others that report similar results, highlight a significant problem in the development of new therapies to treat disease. With increasing reports of discrepancies in preclinical publications, pharmaceutical companies are being forced to re-evaluate their reliance on academic research. In fact, Bayer recently decided to halt nearly two-thirds of target-validation projects.In this session, we'll report the work we have done to address this issue. We will bring together researchers and representatives from funders and publishers to discuss the issue of reproducibility. We will share funder and publisher initiatives to promote reproducibility and also discuss research practices that lead to more reproducible research such as using proper statistical tests, reporting all experimental data, experimental blinding, and identification and validation of research reagents. We'll also share preliminary results from an Arnold Foundation-funded study to replicate the 50 most high impact cancer biology studies from 2010-1012. Reproducibility ResearchAmgen47 of 53 “landmark” oncology publications could not be reproducedBayerinternal results contradicted academic publications in 43 of 67 oncology and cardiovascular projectsDr. John Ioannidis and colleagues432 publications purporting sex differences in hypertension, multiple sclerosis, or lung cancer, only one data set was reproducible Note: This abstract was not presented at the meeting. Citation Format: Gunn William, Elizabeth Iorns, Elizabeth Silva, Brian Nosek. Preliminary results from the Reproducibility Project: Cancer Biology - a replication of 50 high-impact cancer cell biology papers from 2010-2012. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 5053. doi:10.1158/1538-7445.AM2014-5053

Background: The healthcare system has extremely large volumes of patients' paper medical records (PMRs) scattered throughout various medical facilities. Currently the industry is transitioning to Electronic Medical Records (EMR). Although each source of information is equally important, a complete longitudinal health record is rarely available or currently attainable. The goal of this effort is to convert the existing PMRs into searchable electronic equivalents and merge them with existing EMRs to create a more complete longitudinal health record to support clinical care and biomedical research.Method: Using a subset of PMRs for subjects enrolled in the Clinical Breast Care Project at Walter Reed Army Medical Center, (WRAMC), we are developing an automated method to digitize and index the records, extract the biomedical information and prepare the data for delivery to clinicians and researchers. The electronic records were loaded into a database for immediate access by clinicians. To support translational research, MRs need to be de-identified, and information extracted and loaded into a research database; we used ten MRs to develop the operational method. Several methods were tested in the de-identification process: 1) manually, by striking out the protected health information (PHI) on paper before it was digitized and 2) “electronically”, by redacting the record electronically on the computer after it was digitized. We are in the process of testing automated data extraction tools and natural language processors to automatically de-identify and extract data from the EMR.Result: We quickly realized that only 10% of PMRs existed onsite at WRAMC; remaining MRs were held by the patients or other medical facilities. Approximately 300 PMRs, containing 66,600 pages, were scanned and digitized for this project. We have created a successful digitization process, which includes creating PDFs with hidden and searchable information. We have compared the effort and accuracy of various redaction methods. To de-identify 10 records, it took ∼10 hours manually and ∼20 hours electronically. It took longer electronically because of the preparations to ensure the removed information could not be retrieved. We expect that automated redaction tools will greatly reduce that effort. We also found that the electronic method had a 99% accuracy compared to 96% for the paper method. A portal prototype to allow access to medical records by clinicians and researchers is currently being tested and evaluated.Discussion: Conversion of non-searchable data into an explorable and computable format will enable clinicians to acquire needed information more conveniently in their clinical care including treatment plan development. Similarly, properly de-identified, complete MRs will serve as a rich source of clinical information to support translational research. Although the method we are developing will initially satisfy the CBCP need for clinical service and research, it will be further developed into a full solution to expand into other disease condition fields. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5123.

Background Each year, approximately 13,110 women under age 40 are diagnosed with breast cancer, with 1,200 dying of the disease. There are approximately 250,000 breast cancer survivors living in the US today who were diagnosed under 40. Compared to older women, young women generally face more aggressive cancers, lower survival rates, and unique psychosocial concerns. Breast cancer in women under 40 is rarely studied. Young Survival Coalition (YSC) is the premier global organization dedicated to the critical issues unique to young women and breast cancer. It is a strategic goal of YSC to increase the amount of quality research on young women, to define the greatest research needs for young women with breast cancer, and to advocate these needs to doctors and researchers. In 2001, YSC convened the “Medical Research Symposium on Young Women and Breast Cancer,” consisting of seven researchers from the New York City area from all of the major cancer disciplines. The resulting white paper set an initial YSC agenda on both the current state and future direction for research in young women. In 2012, YSC decided to revisit this agenda, review what progress has been made and what priority research areas remain. Methods In 2012, work on the YSC Research Think Tank (RTT) began. Our goal was to identify the most pressing research questions that would improve the quality and quantity of life for young women diagnosed with breast cancer. YSC assembled doctors, researchers and advocates to focus on six areas of particular importance to its young constituents: risk factors; treatment; metastasis; quality of life; fertility; and pregnancy. Each participant was assigned to a workgroup based on their stated interest and expertise. A young survivor advocate led and coordinated each workgroup. In mid- 2012, these groups met remotely to review the state of the research in each of their assigned areas. They compiled detailed reports summarizing their work and listed the research gaps pertinent to young women. In February, 2013, all RTT participants met in Arlington, Virginia for a two day in-person meeting. Each workgroup briefly presented their work to date and displayed a large poster reflecting what they believed to be the most pressing research questions. During day two of the RTT, attendees rotated through the assigned rooms of three workgroups (other than their own), discussing more fully each of the items that workgroup identified as a research priority. Participants placed each priority on a graph, reflecting how that priority would impact quality and quantity of life for young women. Each workgroup re-assembled and discussed the feedback they received, selecting their top three research priorities. Results Young women with breast cancer remain an understudied population. Taking the knowledge gained and recommendations received at the RTT meeting, YSC is currently drafting a white paper and updated research agenda to be finalized by spring, 2014. These documents will be published and promoted in an effort to focus the research community on the unique issues of young women with breast cancer to extend their quantity and improve their quality of life. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-10-02.

Academic cancer research in the UK is structured around key organizations. The National Cancer Research Institute (NCRI) is a ‘virtual institute’ that brings together government and charitable funders to set priorities and co-ordinate funding of cancer research. NCRI Clinical Studies Groups (CSGs), which provide the site-specific leadership to develop studies, will be adopted into the national portfolio of cancer studies as part of the National Institute for Health Research (NIHR) if the funding is available. The NIHR National Cancer Research Network leads the delivery of research through research networks throughout the UK. Related groups and initiatives facilitate or carry out specific tasks in research development, management and monitoring. Patients have input at all levels and their voice has, throughout the history of NCRI & NCRN, been considered critically important in developing research. The key principles from researchers and clinicians include working together with consumers as partners in the research effort, involving consumers in developing strategy as well as specific initiatives and studies, listening to the consumer voice on research needs and the experience of participating in research, and learning from experience to develop and increase the impact of the consumer role in cancer research. The NCRI Consumer Liaison Group brings together patient and caregiver members to support research development at all levels from the NCRI Board through CSGs to membership of individual Trial and Study Management groups. Impact has been captured in many narratives from researchers, clinicians and patients. Working together in a robust partnership is a particular strength of UK Cancer Research and forms the ideal platform to truly achieve research intended for patient betterment. This is recognized in the recent White Paper: ‘Equity and excellence: Liberating the NHS’. The organization's first decade of patient and public involvement is captured in the NCRI report: Patient, Carer & Public Involvement in Cancer Research. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr LB-73. doi:10.1158/1538-7445.AM2011-LB-73