Evidence map›Paper›PMID 38834238›Full record

ReviewBMJ supportive & palliative care2024

Single-arm clinical trials: design, ethics, principles.

Minyan Wang, Huan Ma, Yun Shi, Haojie Ni, Chu Qin, Conghua Ji

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMJ supportive & palliative care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 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.

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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

6 authors.

Minyan WangZhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Huan MaZhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Yun ShiZhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Haojie NiZhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Chu QinZhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Conghua JiZhejiang Chinese Medical University, Hangzhou, Zhejiang, China jchi2005@126.com.ORCID http://orcid.org/0000-0002-8329-8927

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although randomised controlled trials are considered the gold standard in clinical research, they are not always feasible due to limitations in the study population, challenges in obtaining evidence, high costs and ethical considerations. As a result, single-arm trial designs have emerged as one of the methods to address these issues. Single-arm trials are commonly applied to study advanced-stage cancer, rare diseases, emerging infectious diseases, new treatment methods and medical devices. Single-arm trials have certain ethical advantages over randomised controlled trials, such as providing equitable treatment, respecting patient preferences, addressing rare diseases and timely management of adverse events. While single-arm trials do not adhere to the principles of randomisation and blinding in terms of scientific rigour, they still incorporate principles of control, balance and replication, making the design scientifically reasonable. Compared with randomised controlled trials, single-arm trials require fewer sample sizes and have shorter trial durations, which can help save costs. Compared with cohort studies, single-arm trials involve intervention measures and reduce external interference, resulting in higher levels of evidence. However, single-arm trials also have limitations. Without a parallel control group, there may be biases in interpreting the results. In addition, single-arm trials cannot meet the requirements of randomisation and blinding, thereby limiting their evidence capacity compared with randomised controlled trials. Therefore, researchers consider using single-arm trials as a trial design method only when randomised controlled trials are not feasible.

Indexed as

Clinical Trials as TopicResearch DesignHumansClinical assessmentClinical decisions

Identifiers

PMID38834238
PMCPMC11874317

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.