35 citations · 64 across the 4 of their papers we have counts for
4 papers
The Trial within Cohorts (TwiCs) study design in oncology: Experience and methodological reflections
Rob Kessels, Anne M. May, Miriam Koopman +1
A Trial within Cohorts (TwiCs) study design is a trial design that uses the infrastructure of an observational cohort study to initiate a randomized trial. Upon cohort enrollment,…
Use of Non-concurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
Rajeshwari Sridhara, Olga Marchenko, Qi Jiang +14
This article summarizes the discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forum that took place on December 10, 2020 and was org…
Correction of overfitting bias in regression models
Emanuele Massa, Marianne Jonker, Kit Roes +1
Regression analysis based on many covariates is becoming increasingly common. However, when the number of covariates is of the same order as the number of observations , max…
Combining Evidence from Clinical Trials in Conditional or Accelerated Approval
Manja Deforth, Charlotte Micheloud, Kit C Roes +1
Conditional (European Medicines Agency) or accelerated (U.S. Food and Drug Administration) approval of drugs allow earlier access to promising new treatments that address unmet med…