A multi-laboratory preclinical trial in rodents to assess treatment candidates for acute ischemic stroke

PD Lyden, MA Diniz, F Bosetti, J Lamb… - Science translational …, 2023 - science.org
Human diseases may be modeled in animals to allow preclinical assessment of putative
new clinical interventions. Recent, highly publicized failures of large clinical trials called into …

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 …

The stroke preclinical assessment network: rationale, design, feasibility, and stage 1 results

PD Lyden, F Bosetti, MA Diniz, A Rogatko, JI Koenig… - Stroke, 2022 - Am Heart Assoc
Cerebral ischemia and reperfusion initiate cellular events in brain that lead to neurological
disability. Investigating these cellular events provides ample targets for developing new …

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 …

[HTML][HTML] Platform trials for anaesthesia and perioperative medicine: a narrative review

PS Myles, J Yeung, WS Beattie, EG Ryan… - British Journal of …, 2023 - Elsevier
Large randomised trials provide the most reliable evidence of effectiveness of new
treatments in clinical practice. However, the time and resources required to complete such …

Systematic review of available software for multi-arm multi-stage and platform clinical trial design

EL Meyer, P Mesenbrink, T Mielke, T Parke, D Evans… - Trials, 2021 - Springer
Background In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and
platform trials has increased. However, many design-related questions and questions …

A web application for the design of multi-arm clinical trials

MJ Grayling, JMS Wason - BMC cancer, 2020 - Springer
Background Multi-arm designs provide an effective means of evaluating several treatments
within the same clinical trial. Given the large number of treatments now available for testing …

[HTML][HTML] Bioavailability as Proof to Authorize the Clinical Testing of Neurodegenerative Drugs—Protocols and Advice for the FDA to Meet the ALS Act Vision

SK Niazi - International Journal of Molecular Sciences, 2024 - mdpi.com
Although decades of intensive drug discovery efforts to treat neurodegenerative disorders
(NDs) have failed, around half a million patients in more than 2000 studies continue being …

An order restricted multi‐arm multi‐stage clinical trial design

A Serra, P Mozgunov, T Jaki - Statistics in medicine, 2022 - Wiley Online Library
One family of designs that can noticeably improve efficiency in later stages of drug
development are multi‐arm multi‐stage (MAMS) designs. They allow several arms to be …

[HTML][HTML] NCC: An R-package for analysis and simulation of platform trials with non-concurrent controls

P Krotka, K Hees, P Jacko, D Magirr, M Posch, MB Roig - SoftwareX, 2023 - Elsevier
Platform trials evaluate the efficacy of multiple treatments, allowing for late entry of the
experimental arms and enabling efficiency gains by sharing controls. The power of …