Prospective Head and Neck Cancer Research: A Four‐Decade Bibliometric Perspective

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/139977/1/onco0584.pd

Development and Validation of the Geoscience Quantitative Preparation Survey (GQPS)

We have created a new survey instrument for national implementation, based on the results of our recent qualitative investigations, the Career Masters Survey from the American Geosciences Institute, and the suite of career skills recommended by the Summit on the Future of Undergraduate Geoscience Education initiative. The Geoscience Quantitative Preparation Survey (GQPS) is designed for geoscientists – geologists only during initial pilot testing – who are 3-10 years removed from BS/BA graduation with 3-7 years of related work experience. The GQPS is designed to measure (1) self-efficacy in a variety of quantitative skills, (2) whether participants use these various quantitative skills at work and/or (3) outside of work, and (4) whether participants are satisfied with the problem solving, quantitative communication, and computer-based skills they received during their undergraduate education, both in their geoscience departments and (5) at their universities outside of their departments. This presentation will focus primarily on the background, development, and validation of the GQPS survey instrument. The GQPS was loosely based on a medical patient numeracy test, the Subjective Numeracy Scale (Fagerlin et al 2007). We took the general questions of the SNS – designed to determine whether medical patients could understand quantitative instructions involving things like medications – and expanded the level of math skills discussed while re-framing the questions for a geoscience context. Validation of the GQPS is a three-part process. First, the survey was reviewed iteratively by a panel of three survey experts. Second, a group of ten graduate student volunteers took the draft version of the instrument while giving an oral account of any confusion or inconsistency noted. Third, we will validate quantitatively using the official responses to the survey and will include responses for validation from participants that fall outside the target range of experience and/or years-from-graduation

Early, precise, and safe clinical evaluation of the pharmacodynamic effects of novel agents in the intact human tumor microenvironment

Introduction: Drug development is systemically inefficient. Research and development costs for novel therapeutics average hundreds of millions to billions of dollars, with the overall likelihood of approval estimated to be as low as 6.7% for oncology drugs. Over half of these failures are due to a lack of drug efficacy. This pervasive and repeated low rate of success exemplifies how preclinical models fail to adequately replicate the complexity and heterogeneity of human cancer. Therefore, new methods of evaluation, early in the development trajectory, are essential both to rule-in and rule-out novel agents with more rigor and speed, but also to spare clinical trial patients from the potentially toxic sequelae (high risk) of testing investigational agents that have a low likelihood of producing a response (low benefit). Methods: The clinical in vivo oncology (CIVO®) platform was designed to change this drug development paradigm. CIVO precisely delivers microdose quantities of up to 8 drugs or combinations directly into patient tumors 4–96 h prior to planned surgical resection. Resected tissue is then analyzed for responses at each site of intratumoral drug exposure. Results: To date, CIVO has been used safely in 6 clinical trials, including 68 subjects, with 5 investigational and 17 approved agents. Resected tissues were analyzed initially using immunohistochemistry and in situ hybridization assays (115 biomarkers). As technology advanced, the platform was paired with spatial biology analysis platforms, to successfully track anti-neoplastic and immune-modulating activity of the injected agents in the intact tumor microenvironment. Discussion: Herein we provide a report of the use of CIVO technology in patients, a depiction of the robust analysis methods enabled by this platform, and a description of the operational and regulatory mechanisms used to deploy this approach in synergistic partnership with pharmaceutical partners. We further detail how use of the CIVO platform is a clinically safe and scientifically precise alternative or complement to preclinical efficacy modeling, with outputs that inform, streamline, and de-risk drug development