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Did you mean estimated (1,704,517 results)?
Application of the Estimand Framework to Anesthesia Trials.
De Silva AP, Leslie K, Braat S, Grobler AC. De Silva AP, et al. Anesthesiology. 2024 Jul 1;141(1):13-23. doi: 10.1097/ALN.0000000000004966. Anesthesiology. 2024. PMID: 38743905 Review.
This article describes how the estimand framework can be used in anesthesia trials to precisely define the treatment effect to be estimated, key attributes of an estimand, common intercurrent events in anesthesia trials with strategies for handling them, and use of …
This article describes how the estimand framework can be used in anesthesia trials to precisely define the treatment effect to be est …
Estimand in benefit-risk assessment.
Ren X, Chen XG, Wang W, Seifu Y. Ren X, et al. J Biopharm Stat. 2023 Jul 4;33(4):452-465. doi: 10.1080/10543406.2023.2170396. Epub 2023 Feb 8. J Biopharm Stat. 2023. PMID: 36755379
There is lack of systematic discussion on estimand in the context of BRA. This paper initiates the BRA discussion under the estimand framework. By identifying two types of BRA approaches, we summarize and discuss completed clinical trials, using the estimand …
There is lack of systematic discussion on estimand in the context of BRA. This paper initiates the BRA discussion under the estima …
Demystifying the estimand framework: a case study using patient-reported outcomes in oncology.
Fiero MH, Pe M, Weinstock C, King-Kallimanis BL, Komo S, Klepin HD, Gray SW, Bottomley A, Kluetz PG, Sridhara R. Fiero MH, et al. Lancet Oncol. 2020 Oct;21(10):e488-e494. doi: 10.1016/S1470-2045(20)30319-3. Lancet Oncol. 2020. PMID: 33002444 Review.
The estimand framework uses a multidisciplinary approach and can improve design, analysis, and interpretation of PRO results. On the basis of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E9(R1) adde …
The estimand framework uses a multidisciplinary approach and can improve design, analysis, and interpretation of PRO results. On the …
Adopting the estimand framework in prophylactic vaccine trials.
Beckers F, Karkada N, Yang Y, Scott J, Huang L, Klinglmüller F, Fay MP, Englert S, Spiessens B, Van Dromme I, Shekar T, Zhou H, Deng Q, Casula D, Janes H, Moulton LH. Beckers F, et al. Vaccine. 2025 Oct 3;64:127645. doi: 10.1016/j.vaccine.2025.127645. Epub 2025 Sep 3. Vaccine. 2025. PMID: 40907068 Free article. Review.
The estimand framework as outlined in ICH E9(R1) has been extensively discussed and implemented in clinical trials of therapeutic products. ...Finally, we provide considerations and examples for summarizing study estimands and data handling which may be incorporated …
The estimand framework as outlined in ICH E9(R1) has been extensively discussed and implemented in clinical trials of therapeutic pro …
Investigating estimand considerations in adaptive trials: a systematic review.
Piazza F, Wallace H, Phillips R, Cro S, Zenasni Z. Piazza F, et al. Trials. 2026 Feb 6;27(1):197. doi: 10.1186/s13063-026-09490-0. Trials. 2026. PMID: 41645316 Free PMC article. Review.
Fifty-two (36%) articles did not describe any intercurrent events. No articles specified the estimand for any planned interim analyses or considered the implications of adaptations on the primary estimand. CONCLUSIONS: This review provides evidence that there is sti …
Fifty-two (36%) articles did not describe any intercurrent events. No articles specified the estimand for any planned interim analyse …
Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence.
Lynggaard H, McKendrick S, Baird M, Kerwash E, Lanius V, Lasch F, Wright D. Lynggaard H, et al. Br J Clin Pharmacol. 2025 Feb;91(2):310-324. doi: 10.1111/bcp.16347. Epub 2024 Nov 25. Br J Clin Pharmacol. 2025. PMID: 39587445 Free PMC article. Review.
These define an estimand as a precise description of the treatment effect that reflects the scientific question of interest. In December 2022, the US Food and Drug Administration released draft guidance recommending estimands of interest be specified in bioequivalen …
These define an estimand as a precise description of the treatment effect that reflects the scientific question of interest. In Decem …
Current developments of the estimand concept.
Fierenz A, Zapf A. Fierenz A, et al. Pharm Stat. 2024 Nov-Dec;23(6):864-869. doi: 10.1002/pst.2395. Epub 2024 Apr 27. Pharm Stat. 2024. PMID: 38676433 Free PMC article.
Since the introduction of the estimand in therapeutical studies, several adaptions have been developed. This short article highlights the important aspects of the estimand concept. ...Different modified strategies for intercurrent events are presented, as well as ex …
Since the introduction of the estimand in therapeutical studies, several adaptions have been developed. This short article highlights …
PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.
Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzík M; PIONEER 1 Investigators. Aroda VR, et al. Diabetes Care. 2019 Sep;42(9):1724-1732. doi: 10.2337/dc19-0749. Epub 2019 Jun 11. Diabetes Care. 2019. PMID: 31186300
OBJECTIVE: This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficac …
OBJECTIVE: This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, …
Handling Missing Data and Drop Out in Hospice/Palliative Care Trials Through the Estimand Framework.
Grobler AC, Lee KJ, Wong A, Currow DC, Braat S. Grobler AC, et al. J Pain Symptom Manage. 2022 Apr;63(4):e431-e439. doi: 10.1016/j.jpainsymman.2021.12.022. Epub 2021 Dec 23. J Pain Symptom Manage. 2022. PMID: 34954068 Free article. Review.
METHODS: We outline the estimand framework by highlighting the five elements of an estimand: treatment, population, variable, summary measure and intercurrent event handling. ...Defining an estimand is not a statistical activity, but a multi-disciplinary proc …
METHODS: We outline the estimand framework by highlighting the five elements of an estimand: treatment, population, variable, …
Estimand for non-inferiority influenza vaccine immunogenicity trials.
Nauta J. Nauta J. Vaccine. 2024 Feb 6;42(4):840-843. doi: 10.1016/j.vaccine.2024.01.005. Epub 2024 Jan 13. Vaccine. 2024. PMID: 38220488 Clinical Trial.
According to recent regulatory guidance, clinical trial objectives should be translated into estimands, i.e., precise descriptions of that what is to be estimated. Hence, estimands are to be formulated for influenza vaccine immunogenicity (IVI) trials, notably for o …
According to recent regulatory guidance, clinical trial objectives should be translated into estimands, i.e., precise descriptions of …
1,127 results