17,650 research outputs found
Evaluating hybrid controls methodology in early-phase oncology trials: a simulation study based on the MORPHEUS-UC trial
Phase Ib/II oncology trials, despite their small sample sizes, aim to provide
information for optimal internal company decision-making concerning novel drug
development. Hybrid controls (a combination of the current control arm and
controls from one or more sources of historical trial data [HTD]) can be used
to increase the statistical precision. Here we assess combining two sources of
Roche HTD to construct a hybrid control in targeted therapy for decision-making
via an extensive simulation study. Our simulations are based on the real data
of one of the experimental arms and the control arm of the MORPHEUS-UC Phase
Ib/II study and two Roche HTD for atezolizumab monotherapy. We consider
potential complications such as model misspecification, unmeasured confounding,
different sample sizes of current treatment groups, and heterogeneity among the
three trials. We evaluate two frequentist methods (with both Cox and Weibull
accelerated failure time [AFT] models) and three different priors in Bayesian
dynamic borrowing (with a Weibull AFT model), and modifications within each of
those, when estimating the effect of treatment on survival outcomes and
measures of effect such as marginal hazard ratios. We assess the performance of
these methods in different settings and potential of generalizations to
supplement decisions in early-phase oncology trials. The results show that the
proposed joint frequentist methods and noninformative priors within Bayesian
dynamic borrowing with no adjustment on covariates are preferred, especially
when treatment effects across the three trials are heterogeneous. For
generalization of hybrid control methods in such settings we recommend more
simulation studies.Comment: 34 pages, 3 figures, 5 tables. To be appear in Pharmaceutical
Statistic
Raising the visibility of protected data: A pilot data catalog project
Sharing research data that is protected for legal, regulatory, or contractual reasons can be challenging and current mechanisms for doing so may act as barriers to researchers and discourage data sharing. Additionally, the infrastructure commonly used for open data repositories does not easily support responsible sharing of protected data. This chapter presents a case study of an academic university library’s work to configure the existing institutional data repository to function as a data catalog. By engaging in this project, university librarians strive to enhance visibility and access to protected datasets produced at the institution and cultivate a data sharing culture
Motivation, Design, and Ubiquity: A Discussion of Research Ethics and Computer Science
Modern society is permeated with computers, and the software that controls
them can have latent, long-term, and immediate effects that reach far beyond
the actual users of these systems. This places researchers in Computer Science
and Software Engineering in a critical position of influence and
responsibility, more than any other field because computer systems are vital
research tools for other disciplines. This essay presents several key ethical
concerns and responsibilities relating to research in computing. The goal is to
promote awareness and discussion of ethical issues among computer science
researchers. A hypothetical case study is provided, along with questions for
reflection and discussion.Comment: Written as central essay for the Computer Science module of the
LANGURE model curriculum in Research Ethic
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