Evidence map›Paper›PMID 39375767›Full record

ArticleTrials2024

Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the UK, and Germany.

Alexandra Griessbach, Benjamin Speich, Gilles Dutilh, Shaun Treweek, Matthias Schwenkglenks, Matthias Briel, MAking Randomized Trials Affordable (MARTA) Group

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Alexandra GriessbachCLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland. alexandranatacha.griessbach@usb.ch.ORCID http://orcid.org/0000-0003-3726-1856
Benjamin SpeichCLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Gilles DutilhDepartment Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Shaun TreweekHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Matthias SchwenkglenksInstitute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
Matthias BrielCLEAR Methods Center, Division of Clinical Epidemiology, Department Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
MAking Randomized Trials Affordable (MARTA) Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConducting high-quality randomized clinical trials (RCTs) is challenging, time consuming, and resource intense. Academic investigators usually depend on scarce financial resources; however, current literature lacks systematically collected empirical data on the detailed resource use and costs of investigator-initiated RCTs.

methodsThe aim of this study is to generate a database of detailed empirical resource use and cost data from 100 investigator-initiated RCTs in Switzerland, Germany, and the UK. Investigators enter their empirical costs data into an online data collection form, which is followed by a short interview and a detailed cost report. We plan to investigate cost patterns and cost drivers and examine planned versus actual RCT costs as well as explore different strata of costs across the planning, conduct, and finalization phases, in drug and non-drug trials, and across medical fields and countries. DISCUSSION: This study will add detailed empirical data to the limited research on investigator-initiated RCT costs currently available. A study limitation will be that cost data will be retrospective and self-reported, which might be inaccurate depending on how costs were recorded.

trial registrationOpen Science Framework (OSF) https://doi.org/10.17605/OSF.IO/QY2GU . Registered on June 4, 2021.

Indexed as

Randomized Controlled Trials as TopicResearch DesignCosts and Cost AnalysisDatabases, FactualHumansInterviews as TopicObservational Studies as TopicResearch PersonnelSelf ReportSwitzerlandUnited KingdomConductCostsCosts of clinical trialsFinalizationPlanningRCTsResource use

Identifiers

PMID39375767
PMCPMC11457363

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.