Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes ...current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.
We demonstrate how men and women political scientists in PhD-granting departments perceive the professional climates there. We find remarkable differences in how men and women perceive the “cultural” ...climates of their departments, such as the degree to which it is sexist, but not in how they perceive strictly collegial aspects of climate. We also demonstrate that these patterns characterize the perceptions of men and women at both junior and senior ranks. Contrary to some past research, we also find that climate perceptions do not have a general effect on faculty research productivity. Further, perceptions of high departmental sexism by women scholars does not degrade their research productivity.
We document multiple forms of symbolic behavior by members of the U.S. Senate and then offer systematic tests intended to account for variations in such behavior. Our measures of symbolic behavior ...are developed from floor speeches in the Senate, and we demonstrate, first, that the major types of speeches match particular home style activities and other commonly recognized behaviors of legislators. Our empirical tests provide evidence that the frequency with which senators give particular kinds of speeches is predictable by theoretically grounded expectations about their representational, positional, and strategic interests. Our results provide support for the prospect of systematic analysis of symbolic behavior and representation and for developing integrated theory that takes account of symbolic and policy representation simultaneously.
Background
Provider and institutional practices have been shown to have a large impact on cancer clinical trial enrollment. Understanding provider perspectives on screening for trial eligibility is ...necessary to improve enrollment.
Methods
A questionnaire about incentives, barriers, process tools, and infrastructure related to opening trials and referring patients to onsite and offsite trials was administered to diverse stakeholders, including professional societies, advocacy organizations, and industry networks. Descriptive statistics were used to summarize findings.
Results
Overall, 693 responses were received, primarily from physicians (42.7%) and nurses (35.6%) employed at hospital health systems (43.7%) and academic centers (36.5%). Approximately half (49.2%) screened all patients for onsite clinical trials with screening typically done by manual chart review (81.9%). The greatest incentive reported for offering trials was providing the best treatment options for patients (67.7%). Contracting and paperwork (48.5%) were the greatest barriers to opening more onsite trials. Offsite referrals were rare.
Conclusions
Screening for trial eligibility is a largely manual and ad hoc process, with screening and referral to offsite trials occurring infrequently. Administrative and infrastructure barriers commonly prevent sites from opening more onsite trials. These findings suggest that automated trial screening tools built into workflows that screen in a site‐agnostic manner could result in more frequent trial eligibility screening, especially for offsite trials. With recent momentum, in part in response to the COVID‐19 pandemic, to improve clinical trial efficiencies and broaden access and participant diversity, implementing tools to improve screening and referral processes is timely and essential.
Plain Language Summary
There are many factors that contribute to low adult enrollment in cancer clinical trials, but previous research has indicated that provider and institutional barriers are the largest contributors to low cancer clinical trial enrollment.
In this survey, we sought to gain insight into cancer clinical trial enrollment practices from the perspective of health care providers such as physicians and nurses. We found that only approximately half of respondents indicated their institution systematically screens their patients for clinical trials and this process is manual and time consuming. Furthermore, we found that providers infrequently search for and refer patients to clinical trials at other sites.
Creating better screening methods could improve enrollment in clinical trials.
A questionnaire was administered to understand provider perspectives and needs related to screening for cancer clinical trial eligibility, including assessment of incentives, barriers, and infrastructure related to opening and referring to trials. Findings from the survey suggest that automated screening tools built into clinical workflows could result in more frequent trial eligibility screening, especially for offsite trials.
Dyadic Representation Reappraised Hill, Kim Quaile; Hurley, Patricia A.
American journal of political science,
01/1999, Letnik:
43, Številka:
1
Journal Article
Recenzirano
Recent research on representational linkages between legislators and their constituents challenges the long-standing assumption that constituency preferences are exogenous to the linkage process, but ...does not clearly suggest the conditions under which a specific pattern of linkage should exist. Drawing on a diverse collection of prior research, we argue that issues that function as main lines of cleavage between competing political parties should be characterized by reciprocal linkages between mass and elite preferences, while highly complex issues on which party distinctions are unclear should be characterized by no linkages between mass and elite. For salient issues on which the public fails to distinguish party positions, we expect the traditional one-way linkage from mass to elite. We test our theoretical expectations with a unique version of the data from the 1958 American Representation Study-and with explicit predictions for which policy issues addressed in that study should demonstrate which particular pattern of mass-elite linkage. The empirical results, derived from LISREL analyses for three policy areas, are entirely in accord with our predictions.
Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from the American Society of Clinical Oncology and the College of ...American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research.
An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including preanalytical variables, analytical validity, interpretation and reporting, and clinical validity and utility.
The literature search identified 1338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion.
The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens, and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity or clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, reevaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.
Abstract only
300
Background: Current methods to assess site feasibility for industry-funded clinical trials are onerous and delay patient access to novel treatment options and high-quality clinical ...trials. Industry sponsors and contract research organizations (CROs) often probe for unnecessary and/or duplicative information. These burdens prolong trial start-up times and are a barrier to site participation in oncology trials. The American Society of Clinical Oncology (ASCO) Research Community Forum convened a task force to identify ways to improve the site feasibility assessment process. Methods: Data were collected in 3 steps: 1) survey to assess site burdens, 2) collation of sample feasibility questionnaires (FQs), and 3) stakeholder meeting to discuss potential solutions. The task force then developed recommendations for process improvements and obtained stakeholder feedback through a survey. Results: 113 oncology practices (66 community, 47 academic) reported completing a median 5 FQs and 2 pre-study site visits (PSSVs) per month. FQs took a median 2 hours to complete whereas PSSVs took a median 4 hours to complete. Most considered FQ (81%) and PSSV (91%) content redundant to information previously provided, and FQs similar between different sponsors (86%). The median time from first contact to first patient enrolled was 6 months. The 40 respondents to the stakeholder survey represented 19 academic- and 9 community-based sites, 8 industry sponsors, and 4 CROs. Most preferred a model with a short FQ plus a PSSV when there was not a prior relationship. If there was a prior relationship, either a PSSV or teleconference was preferred. All stakeholders identified time savings, expedited start-up, fewer staff resources, and cost savings as the greatest benefits. The greatest barriers to adoption were buy-in from sponsors and CROs, and insufficient information about site capabilities. Conclusions: Site feasibility assessments for industry-sponsored trials are important to ensure patient safety and access to high quality clinical trials. However, current methods are inefficient and time and resource intensive. This initiative provided insights about challenges for sites and the viability of a fundamental change to site feasibility assessments. ASCO recommendations are forthcoming on improving processes, standardizing and minimizing questions, and using portals that are effective across all trials and clinical research scenarios.
A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial ...and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.
Abstract only
e14092
Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and no-value steps that impact research site ...resources and clinical trial participation. This project sought stakeholder feedback on recommendations to transform industry sponsor and contract research organization (CRO) processes for evaluating sites for trials. Methods: An ASCO task force developed recommendations to improve the feasibility assessment process and standardize and centralize questions and forms. A survey was conducted with sites, industry trial sponsors, and CROs to obtain feedback and assess buy-in for the recommendations. Results: Respondents were from 28 oncology research sites (19 academic, 9 community-based), 8 sponsors, and 4 CROs. All stakeholders agreed that the current process is burdensome (93% sites, 90% sponsors, 100% CROs), standardization will improve the process (86% sites, 87% sponsors, 75% CROs). All agreed a centralized portal will reduce burdens (93% sites, 100% sponsors, 75% CROs) and expedite trial start-up (89% sites, 100% sponsors, 75% CROs). Site certification was a viable option for sites (86%) and CROs (75%), but less so for sponsors (57%). Most respondents preferred a two-tier model: 1) a short site questionnaire followed by a pre-study visit for new interactions, and 2) only a pre-study site visit or a teleconference if there is an existing relationship. The greatest benefits were time savings, expedited start-up, reduction in personnel resources, and cost savings. The greatest barriers to adoption were buy-in and alignment from sponsors/CROs and insufficient information about site or protocol. Top predictors of a site’s success on a trial were physician engagement, available patients, and site experience. Conclusions: Site feasibility assessments are important for all stakeholders to establish trial suitability. However, current methods impose tremendous burdens on site resources (reported by authors elsewhere). While this sample is limited, the proposed process and standardization changes show promise to reduce burdens and costs for all stakeholders and expedite patient enrollment onto clinical trials.
This report presents the American Society of Clinical Oncology's (ASCO's) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the ...coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around five goals to ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality. The specific goals are: (1) ensure that clinical research is accessible, affordable, and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain, and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results. Similarly, ASCO also organized its recommendations regarding cancer care delivery around five goals: (1) promote and protect equitable access to high-quality cancer care; (2) support safe delivery of high-quality cancer care; (3) advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care; (4) recognize and address threats to clinician, provider, and patient well-being; and (5) improve patient access to high-quality cancer care via telemedicine. ASCO will work at all levels to advance the recommendations made in this report.
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