H P Selker

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This paper compares the performance of logistic regression to decision-tree induction in classifying patients as having acute cardiac ischemia. This comparison was performed using the database of 5773 patients originally used to develop the logistic-regression tool and test it prospectively. Both the ability to classify cases and the ability to estimate the(More)
We propose an "efficacy-to-effectiveness" (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial. Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous(More)
Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative 1,2 and the proposed US 21st Century Cures Act 3 may ultimately rest on addressing arcane issues of data curation, standardization, and utilization. Improved extraction of information on the safety and(More)
Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single-sponsor, single-drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real-world populations, and create systematic evidence(More)
The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although(More)
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