165 citations · 360 across the 19 of their papers we have counts for
6 papers · 1 filter
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors
Konstantinos Sechidis, Sophie Sun, Yao Chen +8
This paper proposes a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development targeted at clinical trial sponsors. WATCH is designed to address t…
Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation
Björn Bornkamp, Silvia Zaoli, Michela Azzarito +6
We present the motivation, experience and learnings from a data challenge conducted at a large pharmaceutical corporation on the topic of subgroup identification. The data challeng…
Improving the assessment of the probability of success in late stage drug development
Lisa V Hampson, Björn Bornkamp, Björn Holzhauer +6
There are several steps to confirming the safety and efficacy of a new medicine. A sequence of trials, each with its own objectives, is usually required. Quantitative risk metrics…
Principal Stratum Strategy: Potential Role in Drug Development
Björn Bornkamp, Kaspar Rufibach, Jianchang Lin +6
A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristi…
Model Selection versus Model Averaging in Dose Finding Studies
Kirsten Schorning, Björn Bornkamp, Frank Bretz +1
Phase II dose finding studies in clinical drug development are typically conducted to adequately characterize the dose response relationship of a new drug. An important decision is…
Response-adaptive dose-finding under model uncertainty
Björn Bornkamp, Frank Bretz, Holger Dette +1
Dose-finding studies are frequently conducted to evaluate the effect of different doses or concentration levels of a compound on a response of interest. Applications include the in…