Evidence map›Paper›PMID 41523631›Full record

ArticleJournal of clinical and translational science2025

Protocol for applying an enhanced quality-by-design program across the translational science spectrum.

Allison Zumberge Orechwa, Leslie Aguilar, Megan Castiel, Cathelin Huang, Jeanne Dzekov, Nicole M G Maccalla, Wendy Mack, Zoe Mele, Kaelyn Moses, Cecilia Patino-Sutton and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

13 authors.

Allison Zumberge OrechwaSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0001-8152-871X
Leslie AguilarSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Megan CastielSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Cathelin HuangSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.ORCID https://orcid.org/0009-0002-7469-508X
Jeanne DzekovSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Nicole M G MaccallaSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Wendy MackSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0002-2474-7921
Zoe MeleSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Kaelyn MosesSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Cecilia Patino-SuttonDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0001-5742-2157
Saira ShahSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Amytis TowfighiSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.
Thomas BuchananSouthern California Clinical and Translational Science Institute, University of Southern California, Los Angeles, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The quality by design (QbD) framework holds promise for improving success rates for completion of clinical studies, which often fail to complete on time. Initially used in manufacturing, the framework is now frequently applied to clinical trials to anticipate risks and avoid challenges that impact study completion or the credibility of results. The Southern California Clinical and Translational Science Institute created and implemented a program based on QbD to increase the success of research studies, including clinical trials and other study designs, being conducted by scholars in our Mentored Career Development Program and awardees in our Pilot Grant Programs. The program's three components are QbD Design Studios, project management, and team science support. The overall goal is to increase study quality and efficiency, thereby improving study completion success rates and, ultimately, driving innovations in healthcare and public health. The current article describes QbD program elements in detail, along with preliminary results from initial implementation, approaches for evaluating the program's implementation and impact on study success, and plans to disseminate the program widely.

Indexed as

clinical research efficiencyoperationsquality by design (QbD)risk-based monitoringTranslational science

Identifiers

PMID41523631
PMCPMC12779482

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.