Evidence map›Paper›PMID 28670507›Full record

ArticleTherapeutic innovation & regulatory science2014

Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges.

Olga Marchenko, Valerii Fedorov, J Jack Lee, Christy Nolan, José Pinheiro

Abstract read
In one paragraph

Article in Therapeutic innovation & regulatory science, 2014. 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. Observational
  2. Article
  3. From metabolism to mind: The expanding role of the GLP-1 receptor in neurotherapeutics.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  4. Article
  5. Review
  6. Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Review
  7. Review
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

5 authors.

Olga MarchenkoCenter for Statistics in Drug Development, Innovation, Quintiles, Durham, NC.
Valerii FedorovPredictive Analytics, Innovation, Quintiles, Durham, NC.
J Jack LeeDepartment of Biostatistics, Division of Quantitative Sciences, University of Texas MD Anderson Cancer Center, Houston, TX.
Christy NolanInnovation, Quintiles, Durham, NC.
José PinheiroQuantitative Decision Strategies, Janssen Research & Development, LLC.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

In this paper, we describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early phase adaptive clinical trials. The BATTLE trial - the first completed, biomarker-based, Bayesian adaptive randomized study in lung cancer - is presented as a case study to illustrate main ideas and share learnings.

Indexed as

Adaptive designclinical trial managementdata monitoring committeeearly phase designsmodeling and simulation

Identifiers

PMID28670507
PMCPMC5489916

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.