Even for a successful drug, the risk/benefit balance of trials was similar to phase I cancer trials in general. Sunitinib monotherapy development showed worsening risk/benefit, and the testing of new indications responded slowly to evidence that sunitinib monotherapy would not extend to new malignancies. Research decision-making should draw on evidence from whole research programs rather than a narrow band of studies in the same indication.

Key PointsQuestionAre there gender-based and generational differences in how physicians in the Department of Medicine at the University of Calgary perceive and experience gender inequity?FindingsThis mixed-methods study demonstrated that men physicians perceive that the culture is more favorable for women than women physicians. Junior women physicians reported experiencing greater bias and discrimination compared with their men peers, while senior men physicians perceived little or no gender inequity for women physicians.MeaningThis study suggests that there are gender-based and generational differences in how gender inequities are perceived and experienced in medicine.

Objective To quantify the proportion of trials for unsuccessfully licensed drugs that are not published.Design A systematic assessment of the availability of published research reports for publicly registered trials testing drugs stalling in clinical development ("stalled drugs") and drugs receiving regulatory licensure in the same time period ("licensed drugs").Data sources Searches of clinicaltrials.gov, Google Scholar, PubMed, Embase, and electronic query of contacts in registries to identify trials and assess publication status. Eligibility criteria ResultsThe unadjusted publication proportion for registered trials of licensed drugs was 75% (72/96) versus 37% (30/81) for stalled drugs. The adjusted hazard ratio for publication was 2.7 (95% confidence interval 1.7 to 4.3) in favour of licensed drug trials. Higher publication rates for licensed drug trials were observed regardless of disease type, sponsorship, trial phase, and geography. The rate of non-publication of stalled drug trials was significantly higher for studies that did not complete enrolment compared with licensed drug trials. A total of 20 135 patients participated in trials of stalled drugs that were never published. ConclusionsMuch of the information collected in unsuccessful drug trials is inaccessible to the broader research and practice communities. These findings provide an evidence base and rationale for policy reforms aimed at promoting transparency, ethics, and accountability in clinical research.

Purpose: In principle, nondiagnostic biopsies for pharmacodynamic (PD) studies are carried out to inform decision-making in drug development. Because such procedures have no therapeutic value, their ethical justification requires that results be published. We aimed to assess the frequency of nonpublication of PD data in early phase cancer trials and to identify factors that prevent full publication of data.Methods: We identified a sample of early-phase cancer trials containing invasive nondiagnostic tissue procurement for PD analysis from American Society of Clinical Oncologyand American Association for Cancer Research meeting abstracts published between 1995 and 2005. These trials were followed to publication to determine frequency of nonpublication of PD data. Corresponding authors on early-phase cancer trials using invasive nondiagnostic research procedures were also surveyed to identify factors preventing full publication of PD data.Results: In a sample of 90 trials, 22.2% (20 trials) resulted in no trial publication. Of published trials expected to contain PD reports, 16 (17.8%) did not include any PD data, and 21 (23.3%) reported incomplete PD data. We surveyed 92 authors; nonpublication was regarded as a frequent occurrence, and the most commonly cited barrier to full publication of PD data was strategic considerations in publication (58.8% of responding authors).Conclusions: Our results suggest ways that investigators, study planners, and reviewers can improve the burden/knowledge value balance in PD studies. Clin Cancer Res; 18(23); 6478-84. Ó2012 AACR.

BACKGROUND: Some gender-based disparities in medicine may relate to pregnancy and parenthood. An understanding of the challenges faced by pregnant physicians and physician parents is needed to design policies and interventions to reduce these disparities. OBJECTIVE: Our objective was to characterize workrelated barriers related to pregnancy and parenthood described by physicians. DESIGN: We performed framework analysis of qualitative data collected through individual, semi-structured interviews between May and October 2018. Data related to pregnancy or parenthood were organized chronologically to understand barriers throughout the process of pregnancy, planning a parental leave, taking a parental leave, returning from parental leave, and parenting as a physician. PARTICIPANTS: Physician faculty members of all genders, including parents and non-parents, from a single department at a large academic medical school in Canada were invited to participate in a department-wide study broadly exploring gender equity. A P P R O A C H :T h e m a t i c a n a l y s i s g u i d e d b y constructivism. KEY RESULTS: Twenty-eight physicians were interviewed (7.2% of eligible physicians), including 22 women and 6 men, of which 18 were parents (15 mothers and 3 fathers). Common barriers included a lack of systems-level guidelines for pregnancy and parental leave, inconsistent workplace accommodations for pregnant physicians, a lack of guidance and support for planning parental leaves, and difficulties obtaining clinical coverage for parental leave. Without systems-level guidance, participants had to individually navigate challenges and resolve these difficulties, including negotiating with their leadership for benefits. This led to stress, wasted time and effort, and raised questions about fairness within the department. CONCLUSIONS: Physician parents face unique challenges navigating institutional policies as well as planning and taking parental leave. Systems-level interventions such as policies for pregnancy, parental leave, and return to work are needed to address barriers experienced by physician parents.

While cohesive teams are essential to advancing interdisciplinary research, few frameworks exist to guide team development. In this article, eight academic women adopt a participatory process of inter-relational reflexivity to reflect upon our interdisciplinary research and propose a best-practice framework for sustained effectiveness of interdisciplinary collaboration.

Purpose Student mental well-being is a matter of increasing concern on university campuses around the world. Social, psychological, academic and career aspects of graduate learning are enriched through peer mentorship. Peer-mentoring experiences and the impacts of these relationships on the mental well-being of graduate students remain underexplored in the scholarship of teaching and learning. The purpose of this study was to explore how engagement in formal and informal peer mentorship, as described by students across four academic disciplines, impacts the social connectedness and well-being of graduate students. Design/methodology/approach A convergent mixed methods research design was used, with quantitative and qualitative data gathered in parallel to gain a comprehensive, corroborated and integrated understanding of graduate students’ perspectives and experiences with peer mentorship. Online survey and interview data were collected from graduate thesis-based master’s EdD and PhD students in education, medicine, nursing and social work. The data were analyzed using descriptive statistics and thematic analysis. Findings The authors found a commonality of graduate student experiences across disciplines with respect to the diverse psychosocial impacts of graduate peer mentorship. Peer-mentoring relationships offered mentees emotional support, motivation and a sense of community and offered mentors opportunities for self-development and gratification. Originality/value This research is unique in its in-depth exploration of the interdisciplinary perspectives and experiences of graduate students from Education, Nursing, Medicine and Social Work. While further research is needed to explore the implementation of structural approaches to support the development of peer-mentoring relationships in graduate education, the multidisciplinary focus and depth and breadth of this inquiry suggest the potential transferability of the study findings to other disciplines and academic settings. The findings from this study further highlight the need for strategic activation of existing program resources to foster greater connectedness and well-being among graduate students.

Background:Tumour biopsy for pharmacodynamic (PD) study is increasingly common in early-phase cancer trials. As they are non-diagnostic, the ethical justification for such procedures rests on their knowledge value. On the premise that knowledge value is related to reporting practices and outcome diversity, we assessed in a sample of recent invasive PD studies within cancer trials.Methods:We assessed reporting practices and outcomes for PD studies in a convenience sample of cancer trials published from 2000 to 2010 that employed invasive, non-diagnostic tissue procurement. Extracted data were used to measure outcome reporting in individual trials. Using a reporting scale we developed for exploratory purposes, we tested whether reporting varied with study characteristics, such as funding source or drug novelty.Results:Reporting varied widely within and across studies. Some practices were sporadically reported, including results of all planned tests (78% trials reporting), use of blinded histopathological assessment (43% trials reporting), biopsy dimensions (38% trials reporting), and description of patient flow through PD analysis (62%). Pharmacodynamic analysis as a primary end point and mandatory biopsy had statistically significant positive relationships with overall quality of reporting. A preponderance of positive results (61% of the studies described positive PD results) suggests possible publication bias.Conclusion:Our results highlight the need for PD-reporting guidelines, and suggest several avenues for improving the risk/benefit for studies involving invasive, non-diagnostic tissue procurement.