Evidence map›Paper›PMID 34363901›Full record

ReviewInternational journal of radiation oncology, biology, physics2022

An Overview of Phase 2 Clinical Trial Designs.

Pedro A Torres-Saavedra, Kathryn A Winter

Registry-linked trialAbstract readReview
In one paragraph

Review in International journal of radiation oncology, biology, physics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06426602 (Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–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.

NCT06426602 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology

TypeinterventionalSponsorAmy WagnerRan2024 to 2026Enrolled40ConditionsDisorders of ConsciousnessArmsmindBEAGLE daily device use
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  13. Reply.Arthritis & rheumatology (Hoboken, N.J.) · 2026
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  18. Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials.Current research in pharmacology and drug discovery · 2025
    Review
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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.

Pedro A Torres-SaavedraNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania. Electronic address: torresp@nrgoncology.org.
Kathryn A WinterNRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, Pennsylvania.

Funding

Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NCI NIH HHS U10 CA180822
6 · The paper itself

Abstract

Clinical trials are studies to test new treatments in humans. Typically, these treatments are evaluated over several phases to assess their safety and efficacy. Phase 1 trials are designed to evaluate the safety and tolerability of a new treatment, typically with a small number of patients (eg, 20-80), generally spread across several dose levels. Phase 2 trials are designed to determine whether the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. These studies usually involve a few hundred patients. This article provides an overview of some of the most commonly used phase 2 designs for clinical trials and emphasizes their critical elements and considerations. Key references to some of the most commonly used phase 2 designs are given to allow the reader to explore in more detail the critical aspects when planning a phase 2 trial. A comparison of 3 potential designs in the context of the NRG-HN002 trial is presented to complement the discussion about phase 2 trials.

Indexed as

Clinical Trials, Phase II as TopicResearch DesignHumans

Identifiers

PMID34363901
PMCPMC8688307

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.