Evidence map›Paper›PMID 33650283›Full record

ArticleClinical and translational science2021

Beyond exposure-response: A tutorial on statistical considerations in dose-ranging studies.

Glen Laird, Lei Xu, Meng Liu, Jin Liu

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 20% of its field
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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. 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

4 authors at 1 institution in 1 country.

Glen LairdVertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
Lei XuVertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
Meng LiuVertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
Jin LiuVertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
Vertex Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dose-ranging studies are a crucial part of the phase II drug development process. They complement the understanding gained from exposure-response analyses. However, the statistical design issues related to dose-ranging studies are not always keenly understood and a poorly designed study can be costly for later development. In this tutorial, we review five key statistical principles in designing such a study. We also describe some popular statistical approaches, including pairwise comparison, modeling, and Multiple Comparison Procedure modeling in the context of principles.

Indexed as

Clinical Trials, Phase II as TopicDose-Response Relationship, DrugModels, StatisticalResearch DesignHumansMaximum Tolerated Dose

Identifiers

PMID33650283
PMCPMC8301570
OpenAlexW3135075390

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.