Evidence map›Paper›PMID 38438349›Full record

ReviewSignal transduction and targeted therapy2024

New clinical trial design in precision medicine: discovery, development and direction.

Xiao-Peng Duan, Bao-Dong Qin, Xiao-Dong Jiao, Ke Liu, Zhan Wang, Yuan-Sheng Zang

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 4 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

116 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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56 more citing papers are in PubMed but not listed here.

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.

Xiao-Peng Duan *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.ORCID 0000-0002-2421-1756
Bao-Dong Qin *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Xiao-Dong Jiao *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Ke Liu *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Zhan Wang *Department of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China.
Yuan-Sheng ZangDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University, Shanghai, China. doctorzangys@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the era of precision medicine, it has been increasingly recognized that individuals with a certain disease are complex and different from each other. Due to the underestimation of the significant heterogeneity across participants in traditional "one-size-fits-all" trials, patient-centered trials that could provide optimal therapy customization to individuals with specific biomarkers were developed including the basket, umbrella, and platform trial designs under the master protocol framework. In recent years, the successive FDA approval of indications based on biomarker-guided master protocol designs has demonstrated that these new clinical trials are ushering in tremendous opportunities. Despite the rapid increase in the number of basket, umbrella, and platform trials, the current clinical and research understanding of these new trial designs, as compared with traditional trial designs, remains limited. The majority of the research focuses on methodologies, and there is a lack of in-depth insight concerning the underlying biological logic of these new clinical trial designs. Therefore, we provide this comprehensive review of the discovery and development of basket, umbrella, and platform trials and their underlying logic from the perspective of precision medicine. Meanwhile, we discuss future directions on the potential development of these new clinical design in view of the "Precision Pro", "Dynamic Precision", and "Intelligent Precision". This review would assist trial-related researchers to enhance the innovation and feasibility of clinical trial designs by expounding the underlying logic, which be essential to accelerate the progression of precision medicine.

Indexed as

Precision MedicineAdaptive Clinical Trials as TopicClinical Trials as TopicHumans

Identifiers

PMID38438349
PMCPMC10912713

What OpenQuestion holds

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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.