Evidence map›Paper›PMID 37020207›Full record

ReviewBMC medical research methodology2023

Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials.

Katharina Klatte, Suvitha Subramaniam, Pascal Benkert, Alexandra Schulz, Klaus Ehrlich, Astrid Rösler, Mieke Deschodt, Thomas Fabbro, Christiane Pauli-Magnus, Matthias Briel

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

10 authors.

Katharina KlatteDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland. Katiklatte@icloud.com.
Suvitha SubramaniamDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Pascal BenkertDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Alexandra SchulzDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Klaus EhrlichDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Astrid RöslerDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Mieke DeschodtDepartment of Public Health & Primary Care, KU Leuven, Leuven, Belgium.
Thomas FabbroDepartment of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Christiane Pauli-Magnus *Department of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.
Matthias Briel *Department of Clinical Research, University Hospital Basel and University of Basel, Spitalstrasse 12, Basel, CH- 4031, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. Thoroughly identifying trial-specific risks to enable focussing of monitoring and management efforts on these critical areas during trial conduct may allow for the timely initiation of corrective action and to improve the efficiency of trial conduct. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard.

methodsWe performed a literature review to identify risk indicators and trial monitoring approaches followed by a contextual analysis involving local, national and international stakeholders. Based on this work we developed a risk-tailored management approach with integrated monitoring for RCTs and including a visualizing trial dashboard. We piloted the approach and refined it in an iterative process based on feedback from stakeholders and performed formal user testing with investigators and staff of two clinical trials.

resultsThe developed risk assessment comprises four domains (patient safety and rights, overall trial management, intervention management, trial data). An accompanying manual provides rationales and detailed instructions for the risk assessment. We programmed two trial dashboards tailored to one medical and one surgical RCT to manage identified trial risks based on daily exports of accumulating trial data. We made the code for a generic dashboard available on GitHub that can be adapted to individual trials.

conclusionsThe presented trial management approach with integrated monitoring enables user-friendly, continuous checking of critical elements of trial conduct to support trial teams in the academic setting. Further work is needed in order to show effectiveness of the dashboard in terms of safe trial conduct and successful completion of clinical trials.

Indexed as

Patient SafetyResearch PersonnelHumansRecordsRisk AssessmentRisk FactorsClinical trialRisk-tailored monitoringTrial dashboardTrial management

Identifiers

PMID37020207
PMCPMC10074803

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.