Table · dataset · 2026
Estimation After Selection in Seamless Phase II/III Drop-the-Losers Trials with Time-to-Event Endpoints
Listed in HKU DataHub and figshare and Loughborough Research Repository and UP Research Data Repository — shown once because both records carry DOI 10.6084/m9.figshare.34013854.v1
<p>Seamless Phase II/III clinical trials are increasingly used in modern drug development, supported by regulatory guidance from the U.S. Food and Drug Administration (FDA) emphasizing efficiency and valid post-selection inference.
Description
A common approach is the drop-the-losers (DTL) design, where inferior treatments are eliminated at an interim stage and only the most promising arm proceeds to confirmation. However, such data-driven selection introduces bias in estimating the selected treatment effect.
While post-selection inference is well studied under normality, many clinically relevant endpoints, particularly time-to-event outcomes, are positively skewed and better modeled using a gamma distribution. In this paper, we develop a unified estimation framework for two-stage DTL designs with gamma-distributed endpoints. Assuming a known common shape parameter and unknown scale parameters, we derive the uniformly minimum variance conditionally unbiased estimator (UMVCUE) of the selected mean.
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Under a scaled squared error loss, we establish the minimaxity of the generalized Bayes estimator and provide conditions for inadmissibility of scale-equivariant estimators.</p> <p>To ensure practical utility, we extend the framework to accommodate relaxed foundational assumptions. The generalized Bayes estimator maintains its superior risk profile even when the shape parameter is unknown and estimated from data. Furthermore, the proposed estimators demonstrate robustness under model misspecification (Weibull, log-normal, piecewise exponential) and adapt to unequal shape parameters across arms.
Crucially, we expand the design for right-censored data using conditional maximum likelihood and MCMC-driven Bayesian approaches. Supported by extensive simulations, the methodology is illustrated using uncensored leukemia and right-censored lung cancer datasets.</p>
Links
Where it is published
- DOI doi.org/10.6084/m9.figshare.34013854.v1 ↗
DOI / persistent id · from datahub hku hk
Catalogue records · 1
- OAI-PMH record api.figshare.com/v2/oai?verb=GetRecord&metadataPrefix=oai_dc&identifier=oai%3Af… ↗
metadata API · from datahub hku hk
Topics
- From keywords
- Astronomy & Astrophysics · Bioinformatics and computational biology · Bioinformatics and computational biology · Bioinformatics and computational biology · Bioinformatics and computational biology · Chemistry · Chemistry · Computer Science & AI · Computer Science & AI · Earth & Environmental Science · Earth & Environmental Science · Earth & Environmental Science · Earth & Environmental Science · Economics & Finance · Economics & Finance · Engineering · Engineering · Engineering · Evolutionary biology · Evolutionary biology · Evolutionary biology · Evolutionary biology · Genetics · Genetics · Genetics · Genetics · Humanities · Humanities · Humanities · Life Sciences · Life Sciences · Life Sciences · Life Sciences · Materials Science · Mathematics & Statistics · Mathematics & Statistics · Mathematics & Statistics · Mathematics & Statistics · Medicine & Health · Medicine & Health · Medicine & Health · Medicine & Health · Ocean & Atmospheric Science · Psychology & Behavioral Science · Research, science and technology policy · Research, science and technology policy · Research, science and technology policy · Research, science and technology policy · Social Science · Social Science · Social Science
- Inferred from text
- Cancer 75%
Provenance · 4 source records, 57 field assertions
| Source | Key | Last seen | Raw |
|---|---|---|---|
| HKU DataHub | oai:figshare.com:article/34013854 | 10 d ago | JSON v1 |
| figshare | oai:figshare.com:article/34013854 | 9 d ago | JSON v1 |
| Loughborough Research Repository | oai:figshare.com:article/34013854 | 9 d ago | JSON v1 |
| UP Research Data Repository | oai:figshare.com:article/34013854 | 9 d ago | JSON v1 |
| Field | Assertion | Extractor | Evidence |
|---|---|---|---|
| access_level | source · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| concepts[disease].local:disease:cancer | enrichment · datahub hku hk | keyword-concept-rules@1.0.0 | title+description (75%) |
| concepts[field].anzsrc:field:440710 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Science Policy'] |
| concepts[field].anzsrc:field:440710 | mapping · datahub hku hk | vocabulary-mapper@1.0.0 | keywords['Science Policy'] |
| concepts[field].anzsrc:field:440710 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Science Policy'] |
| concepts[field].anzsrc:field:440710 | mapping · researchdata up ac za | vocabulary-mapper@1.0.0 | keywords['Science Policy'] |
| concepts[field].anzsrc:group:3102 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Computational Biology'] |
| concepts[field].anzsrc:group:3102 | mapping · researchdata up ac za | vocabulary-mapper@1.0.0 | keywords['Computational Biology'] |
| concepts[field].anzsrc:group:3102 | mapping · datahub hku hk | vocabulary-mapper@1.0.0 | keywords['Computational Biology'] |
| concepts[field].anzsrc:group:3102 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Computational Biology'] |
| concepts[field].anzsrc:group:3104 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Evolutionary Biology'] |
| concepts[field].anzsrc:group:3104 | mapping · researchdata up ac za | vocabulary-mapper@1.0.0 | keywords['Evolutionary Biology'] |
| concepts[field].anzsrc:group:3104 | mapping · datahub hku hk | vocabulary-mapper@1.0.0 | keywords['Evolutionary Biology'] |
| concepts[field].anzsrc:group:3104 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Evolutionary Biology'] |
| concepts[field].anzsrc:group:3105 | mapping · datahub hku hk | vocabulary-mapper@1.0.0 | keywords['Genetics'] |
| concepts[field].anzsrc:group:3105 | mapping · researchdata up ac za | vocabulary-mapper@1.0.0 | keywords['Genetics'] |
| concepts[field].anzsrc:group:3105 | mapping · repository lboro ac uk | vocabulary-mapper@1.0.0 | keywords['Genetics'] |
| concepts[field].anzsrc:group:3105 | mapping · figshare com | vocabulary-mapper@1.0.0 | keywords['Genetics'] |
| concepts[field].local:field:astronomy | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:chemistry | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:chemistry | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:computer-science-ai | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:computer-science-ai | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:earth-environmental | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:economics-finance | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:economics-finance | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:engineering | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:engineering | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:engineering | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:humanities | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:humanities | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:humanities | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:life-sciences | mapping · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| concepts[field].local:field:materials-science | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:mathematics-statistics | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:mathematics-statistics | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:mathematics-statistics | mapping · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| concepts[field].local:field:mathematics-statistics | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:medicine-health | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:ocean-atmospheric | mapping · figshare com | connector:figshare_com@1.0.0 | |
| concepts[field].local:field:psychology-behavioral | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:social-science | mapping · researchdata up ac za | connector:researchdata_up_ac_za@1.0.0 | |
| concepts[field].local:field:social-science | mapping · repository lboro ac uk | connector:repository_lboro_ac_uk@1.0.0 | |
| concepts[field].local:field:social-science | mapping · figshare com | connector:figshare_com@1.0.0 | |
| description | source · datahub hku hk | connector:datahub_hku_hk@1.0.0 | /metadata/dc/description |
| license | source · datahub hku hk | connector:datahub_hku_hk@1.0.0 | /metadata/dc/rights |
| publication_date | source · datahub hku hk | connector:datahub_hku_hk@1.0.0 | |
| title | source · datahub hku hk | connector:datahub_hku_hk@1.0.0 | /metadata/dc/title |