Evidence map›Paper›PMID 40549132›Full record

ArticleOphthalmology and therapy2025

Clinical Trial Simulation in Geographic Atrophy: Patient, Caregiver, and Trial Site Staff Perspectives.

Ivana Gunderson, Asma Burale, Bill J Best, Cynthia I Tung, Jochen Huber, Lisa Marsh

Abstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. 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

6 authors.

Ivana GundersonAustin Clinical Research, 9707 Anderson Mill Road, Suite 100, Austin, TX, 78750, USA. igunderson@austinclinicalresearch.com.ORCID http://orcid.org/0009-0007-3604-9761
Asma BuraleMoorfields Eye Hospital, NIHR Clinical Research Facility, Moorfields Eye Hospital NHS Foundation Trust, Moorfields at City Road, 162 City Road, London, EC1V 2PD, UK. a.burale@nhs.net.
Bill J BestPatient Author, Dronfield, Derbyshire, UK.
Cynthia I TungBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Jochen HuberBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Lisa MarshBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe perspectives of patients with geographic atrophy (GA) should be considered when planning new clinical trials to ensure that real-world patient needs are addressed. The purpose of this study was to explore the perspectives of patients, caregivers, and trial site staff on designing and planning a phase 2 clinical trial in GA.

methodsThis cross-sectional study included patients with GA and their caregivers, trial site staff, and investigators from Germany, the UK, and the USA. Participants were asked to spend 30 min reviewing a simulated trial design communicated as a simple video animation with a voiceover. Subsequently, a 90-min web-assisted telephone interview and survey was conducted to identify problems with the design of the simulated trial and explore potential solutions and improvements.

resultsPatients (n = 11), caregivers (n = 11), and site staff (n = 16) completed the survey after reviewing the simulated trial design. Survey responses suggested that study recruitment could be facilitated via widespread advertisement and by including a short washout period, i.e., the time period during which patients receive no medication prior to commencing the study drug to ensure that other treatments do not impact the study results. Survey suggestions for reducing the burden of trial participation included minimizing the number and frequency of trial visits, enabling assessments to be completed at home, and making the schedule of trial visits flexible. Appropriate investment in study center facilities was recommended. In addition, survey respondents proposed that providing transport could be highly beneficial, potentially enabling patients and caregivers to attend trial visits more easily.

conclusionsThis study provides valuable information on the viewpoints of patients, caregivers, and trial site staff regarding trial design. Accounting for these perspectives when designing future clinical trials may help ensure successful trial completion and promote positive perceptions of clinical research.

Indexed as

Clinical trial designGeographic atrophyPatient perspectiveTelephone interview

Identifiers

PMID40549132
PMCPMC12271047

What OpenQuestion holds

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Registered trials

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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.