Background: Little is known about outcomes of adjuvant-treated melanoma patients beyond the clinical trial setting. Since 2019, adjuvant-treated melanoma patients have been registered in the DMTR,... Show moreBackground: Little is known about outcomes of adjuvant-treated melanoma patients beyond the clinical trial setting. Since 2019, adjuvant-treated melanoma patients have been registered in the DMTR, a population-based registry to monitor the quality and safety of melanoma care in the Netherlands. This study aims to describe treatment patterns, relapse, and toxicity rates of adjuvant-treated melanoma patients beyond the clinical trial setting.Methods: Analyses were performed on adjuvant-treated melanoma patients included in the DMTR. Descriptive statistics were used to analyse patient-, and treatment characteristics. A baseline registration completeness analysis was performed, and an analysis on trial eligibility in clinical practice patients. Recurrence-free survival (RFS) at 12-months was estimated with the Kaplan-Meier method.Results: A total of 641 patients were treated with adjuvant anti-PD-1 therapy. RFS at 12-months was 70.6% (95% CI, 66.9-74.6) with a median follow-up of 12.8 months. Sex, stage of disease and Breslow thickness were associated with a higher hazard for RFS. Eighteen per cent of the anti-PD-1-treated patients developed grade >= 3 toxicity. Sixty-one per cent of patients prematurely discontinued anti-PD-1 therapy.Conclusion: Adjuvant anti-PD-1 treatment of resected stage III/IV melanoma in daily practice showed slightly higher toxicity rates and more frequent premature discontinuation but similar RFS rates compared to trials. (C) 2021 The Authors. Published by Elsevier Ltd. Show less
Oijen, J.C.F. van; Grit, K.J.; Bos, W.J.W.; Bal, R. 2021
The complexity of regulations governing investigator-initiated trials (IITs) places a great burden on hospitals. Consequently, many hospitals seek to alleviate regulatory pressures by seeking an... Show moreThe complexity of regulations governing investigator-initiated trials (IITs) places a great burden on hospitals. Consequently, many hospitals seek to alleviate regulatory pressures by seeking an alternative quality management system (QMS). This paper takes the Netherlands as a case. To investigate how QMSs for IITs are organized in Dutch hospitals, we adopted the theoretical concepts of mentoring and monitoring in a mixed methods study in the period 2014-2018. In clinical practice and international guidelines, monitoring is seen as the standard quality assurance for ongoing trials. However, hospitals have implemented monitoring programs that resemble mentoring. The contrast between these ideal types is less pronounced in practice as both combine elements of compliance and feedback for learning in practice. In a monitoring setting, learning is one-way, from monitor to researcher; whereas mentoring focuses on mutual support and learning. To tackle problems in each system, the authority of the Board of Directors (BoD) and the BoD's relationship with staff members are crucial. We discuss the challenges that BoD and staff face in keeping an integrated view of the various components of QMSs. Show less
Pels, P.; Boog, I.; Florusbosch, H.J.; Kripe, Z.; Minter, T.; Postma, M.; ... ; Richards‐Rissetto, H. 2018
Recent demands for accountability in ‘data management’ by funding agencies, universities, international journals and other academic institutions have worried many anthropologists and ethnographers.... Show moreRecent demands for accountability in ‘data management’ by funding agencies, universities, international journals and other academic institutions have worried many anthropologists and ethnographers. While their demands for transparency and integrity in opening up data for scrutiny seem to enhance scientific integrity, such principles do not always consider the way the social relationships of research are properly maintained. As a springboard, the present Forum, triggered by such recent demands to account for the use of ‘data’, discusses the present state of anthropological research and academic ethics/integrity in a broader perspective. It specifically gives voice to our disciplinary concerns and leads to a principled statement that clarifies a particularly ethnographic position. This position is then discussed by several commentators who treat its viability and necessity against the background of wider developments in anthropology – sustaining the original insight that in ethnography, research materials have been co‐produced before they become commoditised into ‘data’. Finally, in moving beyond such a position, the Forum broadens the issue to the point where other methodologies and forms of ownership of research materials will also need consideration. Show less
This paper provides an overview of the discussion and presentations from the Workshop on the Management of Large CryoEM Facilities held at the New York Structural Biology Center, New York, NY on... Show moreThis paper provides an overview of the discussion and presentations from the Workshop on the Management of Large CryoEM Facilities held at the New York Structural Biology Center, New York, NY on February 6-7, 2017. A major objective of the workshop was to discuss best practices for managing cryoEM facilities. The discussions were largely focused on supporting single-particle methods for cryoEM and topics included: user access, assessing projects, workflow, sample handling, microscopy, data management and processing, and user training. Show less
