[HTML][HTML] Methods for stratification and validation cohorts: a scoping review

T Torres Moral, A Sanchez-Niubo… - Journal of Personalized …, 2022 - mdpi.com
Personalized medicine requires large cohorts for patient stratification and validation of
patient clustering. However, standards and harmonized practices on the methods and tools …

[PDF][PDF] Research methods for clinical trials in personalized medicine: a systematic review

Z Ren, M Davidian, SL George, RM Goldberg… - … , R. Maksymowicz, W …, 2012 - Citeseer
Background: Personalized medicine, the notion that an individual's genetic and other
characteristics can be used to individualize the diagnosis, treatment and prevention of …

Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers

WJ Shih, Y Lin - Statistics in medicine, 2018 - Wiley Online Library
Prospective randomized clinical trials addressing biomarkers are time consuming and
costly, but are necessary for regulatory agencies to approve new therapies with predictive …

Clinical trial designs for predictive biomarker validation: one size does not fit all

SJ Mandrekar, DJ Sargent - Journal of biopharmaceutical statistics, 2009 - Taylor & Francis
Traditionally, anatomic staging systems have been used to provide predictions of individual
patient outcome and, to a lesser extent, guide the choice of treatment in cancer patients …

[HTML][HTML] Biomarkers, subgroup evaluation, and clinical trial design

SG Baker, BS Kramer, DJ Sargent… - Discovery …, 2012 - discoverymedicine.com
Advances in clinical and basic sciences are raising the potential to use genetic and clinical
biomarkers to identify a subgroup of patients who would most likely benefit from treatment …

On the relevance of prognostic information for clinical trials: a theoretical quantification

S Siegfried, S Senn, T Hothorn - Biometrical Journal, 2023 - Wiley Online Library
The question of how individual patient data from cohort studies or historical clinical trials can
be leveraged for designing more powerful, or smaller yet equally powerful, clinical trials …

Predictive biomarker validation in practice: lessons from real trials

SJ Mandrekar, DJ Sargent - Clinical trials, 2010 - journals.sagepub.com
Background With the advent of targeted therapies, biomarkers provide a promising means of
individualizing therapy through an integrated approach to prediction using the genetic …

Too many cohorts and repeated measurements are a waste of resources

FB Tekle, FES Tan, MPF Berger - Journal of Clinical Epidemiology, 2011 - Elsevier
OBJECTIVE: Researchers in Health Sciences and Medicine often use cohort designs to
study treatment effects and changes of outcome variables over time period. The costs of …

[HTML][HTML] A novel framework for classification of selection processes in epidemiological research

J Björk, A Nilsson, C Bonander, U Strömberg - BMC Medical Research …, 2020 - Springer
Background Selection and selection bias are terms that lack consistent definitions and have
varying meaning and usage across disciplines. There is also confusion in current definitions …

Epidemiologic methods: the “art” in the state of the art

DG Kleinbaum - Journal of clinical epidemiology, 2002 - Elsevier
When performing empirical research in public health and medicine, the investigator is
typically faced with a variety of methodologic issues to resolve at the design and analysis …