Oliver N Keene
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Explore the profile of Oliver N Keene including associated specialties, affiliations and a list of published articles.
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32
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3335
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Recent Articles
1.
Lynggaard H, Keene O, Mutze T, Rehal S
Pharm Stat
. 2024 Aug;
23(6):1156-1165.
PMID: 39115134
Most published applications of the estimand framework have focused on superiority trials. However, non-inferiority trials present specific challenges compared to superiority trials. The International Council for Harmonisation of Technical Requirements...
2.
Wright D, Bratton D, Drury T, Keene O, Rehal S, White I
J Biopharm Stat
. 2023 Sep;
34(1):146-148.
PMID: 37747099
No abstract available.
3.
Keene O, Lynggaard H, Englert S, Lanius V, Wright D
BMC Med
. 2023 Jul;
21(1):276.
PMID: 37501156
Background: The estimand for a clinical trial is a precise definition of the treatment effect to be estimated. Traditionally, estimates of treatment effects are based on either an ITT analysis...
4.
Martin N, Papi A, Bratton D, Chan R, Howarth P, Abbott C, et al.
Respir Med
. 2022 Jan;
191:106065.
PMID: 35090690
No abstract available.
5.
Hartley B, Drury T, Lettis S, Mayer B, Keene O, Abellan J
Pharm Stat
. 2022 Jan;
21(3):612-624.
PMID: 34997685
Discontinuation from randomised treatment is a common intercurrent event in clinical trials. When the target estimand uses a treatment policy strategy to deal with this intercurrent event, data after cessation...
6.
Pavord I, Bel E, Bourdin A, Chan R, Han J, Keene O, et al.
Allergy
. 2021 Aug;
77(3):778-797.
PMID: 34402066
Effective treatment of inflammatory diseases is often challenging owing to their heterogeneous pathophysiology. Understanding of the underlying disease mechanisms is improving and it is now clear that eosinophils play a...
7.
Keene O, Wright D, Phillips A, Wright M
Contemp Clin Trials
. 2021 Jun;
108:106494.
PMID: 34186242
For many years there has been a consensus among the Clinical Research community that ITT analysis represents the correct approach for the vast majority of trials. Recent worldwide regulatory guidance...
8.
Best N, Price R, Pouliquen I, Keene O
Pharm Stat
. 2021 Jan;
20(3):551-562.
PMID: 33475231
Assessment of efficacy in important subgroups - such as those defined by sex, age, race and region - in confirmatory trials is typically performed using separate analysis of the specific...
9.
Pavord I, Menzies-Gow A, Buhl R, Chanez P, Dransfield M, Lugogo N, et al.
J Allergy Clin Immunol Pract
. 2020 Sep;
9(3):1121-1132.e7.
PMID: 32889223
The development of mepolizumab, an anti-IL-5 monoclonal antibody for the treatment of severe eosinophilic asthma, is an example of a clinical development program that evolved over time based on sound,...
10.
Keene O, Ruberg S, Schacht A, Akacha M, Lawrance R, Berglind A, et al.
Pharm Stat
. 2020 Jan;
19(4):370-387.
PMID: 31919979
In drug development, we ask ourselves which population, endpoint and treatment comparison should be investigated. In this context, we also debate what matters most to the different stakeholders that are...