A multi-laboratory preclinical trial in rodents to assess treatment candidates for acute ischemic stroke
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 …
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
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 …
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
Cerebral ischemia and reperfusion initiate cellular events in brain that lead to neurological
disability. Investigating these cellular events provides ample targets for developing new …
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 …
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
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 …
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 …
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 …
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 …
(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 …
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
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 …
experimental arms and enabling efficiency gains by sharing controls. The power of …