Evidence map›Paper›PMID 35191170›Full record

ArticlePharmaceutical statistics2022

Utilizing restricted mean duration of response for efficacy evaluation of cancer treatments.

Bo Huang, Lu Tian

Abstract read
In one paragraph

Article in Pharmaceutical statistics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Bo HuangPfizer Inc., Groton, Connecticut, USA.ORCID 0000-0002-3088-9328
Lu TianStanford Medical School, Stanford University, Stanford, California, USA.

Funding

Statistical Methods for Optimizing Personalized Treatment SelectionR01HL089778 · NHLBI · STANFORD UNIVERSITY · PI LU TIAN · 2008 to 2026
$4.8M
NHLBI NIH HHS R01 HL089778
6 · The paper itself

Abstract

In oncology clinical trials, response-based endpoints (time to response, objective response, duration of response [DOR]) are commonly used to detect therapeutic effect to support proof-of-concept or submission decisions. The restricted mean DOR (RMDOR) was recently proposed as a composite nonparametric method to efficiently quantify the treatment effect related to tumor reductions, which offers an intuitive way to perform statistical inference in cross-arm comparison and has since been applied in some Phase III studies. In this paper, we provide further technical details and asymptotic properties of the RMDOR method and discuss the selection of the truncation time. A simulation study is conducted comparing the performance of the proposed method with existing standard methods in hypothesis testing and quantification of treatment efficacy. We use two oncology Phase III examples to illustrate the method. An R package PBIR and a SAS macro are available to perform statistical inference based on the RMDOR.

Indexed as

NeoplasmsResearch DesignComputer SimulationHumansduration of responseestimationrestricted mean duration of responserestricted mean survival timestatistical inference

Identifiers

PMID35191170
PMCPMC10676756

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.