50 citations · 91 across the 7 of their papers we have counts for
7 papers
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Silvia Calderazzo, Sergey Tarima, Carissa Reid +9
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive a…
Clinical trials impacted by the COVID-19 pandemic: Adaptive designs to the rescue?
Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz +6
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the Wo…
Efficient adaptive designs for clinical trials of interventions for COVID-19
Nigel Stallard, Lisa Hampson, Norbert Benda +14
The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clin…
Seamless phase II/III clinical trials using early outcomes for treatment or subgroup selection: Methods and aspects of their implementation
Tim Friede, Nigel Stallard, Nicholas Parsons
Adaptive seamless designs combine confirmatory testing, a domain of phase III trials, with features such as treatment or subgroup selection, typically associated with phase II tria…
Recent advances in methodology for clinical trials in small populations: the InSPiRe project
T. Friede, M. Posch, S. Zohar +19
Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical issues. This l…
Optimizing Trial Designs for Targeted Therapies
Thomas Ondra, Sebastian Jobjörnsson, Robert A. Beckman +4
An important objective in the development of targeted therapies is to identify the populations where the treatment under consideration has positive benefit risk balance. We conside…
Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions
Steffen Unkel, Christian Röver, Nigel Stallard +4
BACKGROUND: Randomized controlled trials (RCTs) are the gold standard design of clinical research to assess interventions. However, RCTs cannot always be applied for practical or e…