[HTML][HTML] The evolution of master protocol clinical trial designs: a systematic literature review

EL Meyer, P Mesenbrink, C Dunger-Baldauf… - Clinical Therapeutics, 2020 - Elsevier
Purpose Recent years have seen a change in the way that clinical trials are being
conducted. There has been a rise of designs more flexible than traditional adaptive and …

Urgently seeking efficiency and sustainability of clinical trials in global health

JJH Park, RF Grais, M Taljaard… - The Lancet Global …, 2021 - thelancet.com
This paper shows the scale of global health research and the context in which we frame the
subsequent papers in the Series. In this Series paper, we provide a historical perspective on …

The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an …

M Dimairo, P Pallmann, J Wason, S Todd, T Jaki… - bmj, 2020 - bmj.com
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without
compromising the validity of conclusions and it is essential to distinguish pre-planned from …

Sample size requirements for multivariate models to predict between-patient differences in best treatments of major depressive disorder

A Luedtke, E Sadikova… - Clinical Psychological …, 2019 - journals.sagepub.com
Clinical trials have documented numerous clinical features, social characteristics, and
biomarkers that are “prescriptive” predictors of depression treatment response, that is …

Distinguishing prognostic and predictive biomarkers: an information theoretic approach

K Sechidis, K Papangelou, PD Metcalfe… - …, 2018 - academic.oup.com
Motivation The identification of biomarkers to support decision-making is central to
personalized medicine, in both clinical and research scenarios. The challenge can be seen …

Efficient adaptive designs for clinical trials of interventions for COVID-19

N Stallard, L Hampson, N Benda… - Statistics in …, 2020 - Taylor & Francis
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 …

Multi-disciplinary fairness considerations in machine learning for clinical trials

I Chien, N Deliu, R Turner, A Weller, S Villar… - Proceedings of the …, 2022 - dl.acm.org
While interest in the application of machine learning to improve healthcare has grown
tremendously in recent years, a number of barriers prevent deployment in medical practice …

Machine learning methods for developing precision treatment rules with observational data

RC Kessler, RM Bossarte, A Luedtke… - … Research and Therapy, 2019 - Elsevier
Clinical trials have identified a variety of predictor variables for use in precision treatment
protocols, ranging from clinical biomarkers and symptom profiles to self-report measures of …

[HTML][HTML] Statistical considerations for subgroup analyses

X Wang, S Piantadosi, J Le-Rademacher… - Journal of thoracic …, 2021 - Elsevier
Randomized clinical trials (RCTs) are conducted to evaluate the effect of an experimental
treatment on outcomes of a target patient population. Eligibility criteria for large trials are …

Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

M Alosh, MF Huque, F Bretz… - Statistics in …, 2017 - Wiley Online Library
Clinical trials target patients who are expected to benefit from a new treatment under
investigation. However, the magnitude of the treatment benefit, if it exists, often depends on …