Evidence map›Paper›PMID 38321191›Full record

ArticleTherapeutic innovation & regulatory science2024

Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting.

Annett Keller, Nathalie van Borrendam, Patrice Benner, Steven Gilbert, Stefano Saino, Debra Jendrasek, Steve Young, Marcus Muli, Jim Wang, Marta Kozińska and 1 more

Abstract read
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In one paragraph

Article in Therapeutic innovation & regulatory science, 2024. 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. Article
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

11 authors.

Annett KellerGlobal Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH &Co. KG, Binger Strasse 173, 55216, Ingelheim, Germany. annett.keller@boehringer-ingelheim.com.ORCID 0009-0002-3698-020X
Nathalie van BorrendamIntegrated Data Analytics and Reporting, Janssen Research and Development, Graaf Engelbertlaan 75, 4837DS, Breda, Netherlands.
Patrice BennerGlobal Data Management and Standards, Merck & Co., Inc, 770 Sumneytown Pike, West Point, PA, 19486, USA.
Steven GilbertStatistical Research and Innovation, Pfizer, 100 Cambridge Park Drive, Cambridge, MA, 02140, USA.
Stefano SainoRisk Evaluation and Adaptive Integrated Monitoring, MSD, V. F.lli Cervi, Palazzo Canova, 20090, Segrate, Milan, Italy.
Debra JendrasekRisk Based Quality Management, Daiichi Sankyo, 211 Mount Airy Rd, Basking Ridge, NJ, 07920, USA.
Steve YoungResearch, Cluepoints, 1000 Continental Drive, Suite 240, King of Prussia, PA, 19406, USA.
Marcus MuliBiostatistics and Research Decision Sciences, Merck & Co., Inc, 351 N. Sumneytown Pike, North Wales, PA, 19454, USA.
Jim WangStatistics & Decision Sciences, Janssen Research and Development, 920 Route 202, Raritan, NJ, 08869, USA.
Marta KozińskaCentralized Monitoring, BioPharmaceuticals Clinical Operations, R&D, AstraZeneca, Postepu 14, 02-676, Warsaw, Poland.
Jun LiuCentralized Monitoring, Astellas, 1 Astellas Way, Northbrook, IL, 60062, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The past years have sharpened the industry's understanding of a Quality by Design (QbD) approach toward clinical trials. Using QbD encourages designing quality into a trial during the planning phase. The identification of Critical to Quality (CtQs) factors and specifically Critical Data and Processes (CD&Ps) is key to such a risk-based monitoring approach. A variable that allows monitoring the evolution of risk regarding the CD&Ps is called a Quality Tolerance Limit (QTL) parameter. These parameters are linked to the scientific question(s) of a trial and may identify the issues that can jeopardize the integrity of trial endpoints. This paper focuses on defining what QTL parameters are and providing general guidance on setting thresholds for these parameters allowing for the derivation of an acceptable range of the risk.

Indexed as

Clinical Trials as TopicHumansQuality ControlResearch DesignCtQ factorData simulationHistorical dataQTL ParameterQTL Threshold setting methodologiesQuality Tolerance Limits (QTLs)

Identifiers

PMID38321191

What OpenQuestion holds

Textmetadata
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.