Search Results

Digital twins and Bayesian dynamic borrowing: Two recent approaches for incorporating historical control data.

• Authors : Burman CF; Early Biometrics & Statistical Innovation, Data Science & Artificial Intelligence, R&D, AstraZeneca, Gothenburg, Sweden.; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.

• Source: Pharmaceutical statistics [Pharm Stat] 2024 Mar 04. Date of Electronic Publication: 2024 Mar 04.Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1539-1612

Record details

The MaxCombo Test Severely Violates the Type I Error Rate.

• Authors : Magirr D; Advanced Methodology and Data Science, Novartis Pharma AG, Basel, Switzerland.; Burman CF

• Source: JAMA oncology [JAMA Oncol] 2023 Apr 01; Vol. 9 (4), pp. 571-572.Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print Cited Medium: Internet ISSN:

Record details

Estimands and Complex Innovative Designs.

• Authors : Collignon O; GlaxoSmithKline, Hertfordshire, UK.; Schiel A

Subjects: Research Design* ; Drug Development*; Humans

• Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2022 Dec; Vol. 112 (6), pp. 1183-1190. Date of Electronic Publication: 2022 Mar 29.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535

Record details

On model-based time trend adjustments in platform trials with non-concurrent controls.

• Authors : Roig MB; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.; Krotka P

Subjects: Sample Size*; Bias ; Humans

• Source: BMC medical research methodology [BMC Med Res Methodol] 2022 Aug 15; Vol. 22 (1), pp. 228. Date of Electronic Publication: 2022 Aug 15.Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288

Record details

A framework for assessing the impact of accelerated approval.

• Authors : Gould AL; Methodology Research, BARDS, Merck & Co., Inc., Kenilworth, New Jersey, United States of America.; Campbell RK

Subjects: Drug Approval* ; Technology Assessment, Biomedical*; Humans

• Source: PloS one [PLoS One] 2022 Jun 24; Vol. 17 (6), pp. e0265712. Date of Electronic Publication: 2022 Jun 24 (Print Publication: 2022).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet

Record details

Improved group sequential Holm procedures for testing multiple correlated hypotheses over time.

• Authors : Öhrn F; Early Biometrics and Statistical Innovation, Data Science and Artificial Intelligence, R&D, AstraZeneca, Gothenburg, Sweden.; Niewczas J

• Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2022 Mar; Vol. 32 (2), pp. 230-246. Date of Electronic Publication: 2021 Oct 22.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

Record details

A modified weighted log-rank test for confirmatory trials with a high proportion of treatment switching.

• Authors : Jiménez JL; Global Drug Development, Novartis Pharma A.G., Basel, Switzerland.; Niewczas J

Subjects: Carcinoma, Renal Cell* ; Treatment Switching*; Kidney Neoplasms

• Source: PloS one [PLoS One] 2021 Nov 15; Vol. 16 (11), pp. e0259178. Date of Electronic Publication: 2021 Nov 15 (Print Publication: 2021).Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet

Record details

Selection bias, investment decisions and treatment effect distributions.

• Authors : Wiklund SJ; Captario, Gothenburg, Sweden.; Burman CF

Subjects: Bayes Theorem*; Bias ; Humans

• Source: Pharmaceutical statistics [Pharm Stat] 2021 Nov; Vol. 20 (6), pp. 1168-1182. Date of Electronic Publication: 2021 May 17.Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1539-1612

Record details

Collaborative Platform Trials to Fight COVID-19: Methodological and Regulatory Considerations for a Better Societal Outcome.

• Authors : Collignon O; GlaxoSmithKline, Stevenage, Hertfordshire, UK.; Burman CF

Subjects: COVID-19*/COVID-19*/COVID-19*/mortality ; Clinical Trials as Topic*/Clinical Trials as Topic*/Clinical Trials as Topic*/legislation & jurisprudence ; Clinical Trials as Topic*/Clinical Trials as Topic*/Clinical Trials as Topic*/organization & administration

• Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Aug; Vol. 110 (2), pp. 311-320. Date of Electronic Publication: 2021 Mar 16.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535

Record details

Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem.

• Authors : Edgar K; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.; Jackson D

• Source: Statistical methods in medical research [Stat Methods Med Res] 2021 Jul; Vol. 30 (7), pp. 1725-1743. Date of Electronic Publication: 2021 Jun 02.Publisher: SAGE Publications Country of Publication: England NLM ID: 9212457 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

Record details