Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

CS Coffey, B Levin, C Clark, C Timmerman… - Clinical …, 2012 - journals.sagepub.com
Background The clinical trials community has a never-ending search for dependable and
reliable ways to improve clinical research. This exploration has led to considerable interest …

Adaptive designs in clinical trials: why use them, and how to run and report them

P Pallmann, AW Bedding, B Choodari-Oskooei… - BMC medicine, 2018 - Springer
Adaptive designs can make clinical trials more flexible by utilising results accumulating in
the trial to modify the trial's course in accordance with pre-specified rules. Trials with an …

Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs

T Burnett, P Mozgunov, P Pallmann, SS Villar… - BMC medicine, 2020 - Springer
Adaptive designs for clinical trials permit alterations to a study in response to accumulating
data in order to make trials more flexible, ethical, and efficient. These benefits are achieved …

Adaptive design clinical trials: a review of the literature and ClinicalTrials. gov

LE Bothwell, J Avorn, NF Khan, AS Kesselheim - BMJ open, 2018 - bmjopen.bmj.com
Objectives This review investigates characteristics of implemented adaptive design clinical
trials and provides examples of regulatory experience with such trials. Design Review of …

Review of draft FDA adaptive design guidance

T Cook, DL DeMets - Journal of Biopharmaceutical Statistics, 2010 - Taylor & Francis
Recent draft Food and Drug Administration (FDA) guidelines on adaptive clinical trial design
and conduct provide a useful background for both academic and industry clinical research …

Adaptive design: results of 2012 survey on perception and use

CC Morgan, S Huyck, M Jenkins… - Therapeutic …, 2014 - journals.sagepub.com
Adaptive designs are increasingly used in clinical trials. The Drug Information Association's
Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among …

CBER's experience with adaptive design clinical trials

M Lin, S Lee, B Zhen, J Scott, A Horne… - Therapeutic …, 2016 - journals.sagepub.com
There is considerable interest among pharmaceutical and other medical product developers
in adaptive clinical trials, in which knowledge learned during the course of a trial affects …

Adaptive trial designs: a review of barriers and opportunities

JA Kairalla, CS Coffey, MA Thomann, KE Muller - Trials, 2012 - Springer
Adaptive designs allow planned modifications based on data accumulating within a study.
The promise of greater flexibility and efficiency stimulates increasing interest in adaptive …

Paradigms for adaptive statistical information designs: practical experiences and strategies

SJ Wang, HM James Hung, R O'Neill - Statistics in medicine, 2012 - Wiley Online Library
In the last decade or so, interest in adaptive design clinical trials has gradually been directed
towards their use in regulatory submissions by pharmaceutical drug sponsors to evaluate …

A review of available software for adaptive clinical trial design

MJ Grayling, GM Wheeler - Clinical Trials, 2020 - journals.sagepub.com
Background/aims: The increasing cost of the drug development process has seen interest in
the use of adaptive trial designs grow substantially. Accordingly, much research has been …