User profiles for "author:Spencer Phillips Hey"

Spencer Phillips Hey

Prism Analytic Technologies
Verified email at prism.bio
Cited by 1773

Assessment of the clinical benefit of cancer drugs receiving accelerated approval

B Gyawali, SP Hey, AS Kesselheim - JAMA Internal Medicine, 2019 - jamanetwork.com
Importance The US Food and Drug Administration's (FDA's) accelerated approval pathway
allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a …

The questionable use of unequal allocation in confirmatory trials

SP Hey, J Kimmelman - Neurology, 2014 - AAN Enterprises
Randomization is the standard means for addressing known and unknown confounders
within the patient population in clinical trials. Although random assignment to treatment arms …

A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing

SG Nicholls, K Carroll, SP Hey, M Zwarenstein… - Journal of clinical …, 2021 - Elsevier
Objective We established a large database of trials to serve as a resource for future
methodological and ethical analyses. Here, we use meta-data to describe the broad …

Are outcome-adaptive allocation trials ethical?

SP Hey, J Kimmelman - Clinical trials, 2015 - journals.sagepub.com
Randomization is firmly established as a cornerstone of clinical trial methodology. Yet, the
ethics of randomization continues to generate controversy. The default, and most efficient …

A comparison of response patterns for progression-free survival and overall survival following treatment for cancer with PD-1 inhibitors: a meta-analysis of correlation …

B Gyawali, SP Hey, AS Kesselheim - JAMA Network Open, 2018 - jamanetwork.com
Importance Based on efficacy results from pivotal randomized clinical trials, PD-1
(programmed cell death 1) inhibitors, such as nivolumab and pembrolizumab, have been …

Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials

M Taljaard, CE Goldstein, B Giraudeau… - Clinical …, 2020 - journals.sagepub.com
Background: Novel rationales for randomizing clusters rather than individuals appear to be
emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment …

Is the concept of clinical equipoise still relevant to research?

SP Hey, AJ London, C Weijer, A Rid, F Miller - BMJ, 2017 - bmj.com
Is the concept of clinical equipoise still relevant to research? | The BMJ Skip to main content
Intended for healthcare professionals Access provided by Google Indexer Subscribe My …

[HTML][HTML] Heterogeneity of antidiabetic treatment effect on the risk of major adverse cardiovascular events in type 2 diabetes: a systematic review and meta-analysis

E D'Andrea, AS Kesselheim, JM Franklin… - Cardiovascular …, 2020 - Springer
Background We explored whether clinically relevant baseline characteristics of patients with
type 2 diabetes can modify the effect of glucagon-like peptide-1 receptor agonists (GLP-1 …

[HTML][HTML] Cell and gene therapy trials: are we facing an 'evidence crisis'?

M Abou-El-Enein, SP Hey - EClinicalMedicine, 2019 - thelancet.com
Cell and Gene Therapy Trials: Are We Facing an ‘Evidence Crisis’? - eClinicalMedicine Skip to
Main Content Advertisement EClinicalMedicine This Journal Back Journal Home Online First …

A systematic review of the food and drug administration's 'exception from informed consent'pathway

WB Feldman, SP Hey, AS Kesselheim - Health Affairs, 2018 - healthaffairs.org
In 1996 the Food and Drug Administration (FDA) created an “exception from informed
consent”(EFIC) pathway for trials conducted on people incapacitated by life-threatening …