Evidence map›Paper›PMID 23399084›Full record

ArticleClinical and translational science2013

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).

Maria Ferris, Victoria Norwood, Milena Radeva, Jennifer J Gassman, Amira Al-Uzri, David Askenazi, Tej Matoo, Maury Pinsk, Amita Sharma, William Smoyer and 8 more

Abstract read
In one paragraph

Article in Clinical and translational science, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
–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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Optimal management of primary focal segmental glomerulosclerosis in adults.International journal of nephrology and renovascular disease · 2017
    Review
  11. Glomerular Diseases: Registries and Clinical Trials.Clinical journal of the American Society of Nephrology : CJASN · 2016
    Article
  12. Article
  13. Article
  14. Pediatric nephrologists' beliefs regarding randomized controlled trials.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2014
    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

18 authors.

Maria FerrisUniversity of North Carolina, Chapel Hill, NC, USA.
Victoria Norwood
Milena Radeva
Jennifer J Gassman
Amira Al-Uzri
David Askenazi
Tej Matoo
Maury Pinsk
Amita Sharma
William Smoyer
Jenna Stults
Shefali Vyas
Robert Weiss
Debbie Gipson
Frederick Kaskel
Aaron Friedman
Marva Moxey-Mims
Howard Trachtman

Funding

UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD: BPCAUL1RR025747 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$44.6M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025750 · NCRR · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI SHAMOON, HARRY · 2008 to 2011
$20.5M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
Focal Glomerulosclerosis Trial Data Coordinating CenterU01DK063490 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI GASSMAN, JENNIFER · 2002 to 2008
$5.6M
Multicenter Trial of Focal GlomerulosclerosisU01DK063455 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GIPSON, DEBBIE S · 2002 to 2009
$2.6M
Tacrolimus vs Intensive Prednisone in Pediatric FSGSU01DK063549 · NIDDK · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI KASKEL, FREDERICK · 2002 to 2007
$2.4M
OPTIMAL TREATMENT OF FOCAL SEGMENTAL GLOMERULOSCLEROSISU01DK063385 · NIDDK · STATE UNIVERSITY NEW YORK STONY BROOK · PI FINE, RICHARD N · 2002 to 2007
$2.1M
Novel Therapies for Resistant FSGSR21DK070341 · NIDDK · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI TRACHTMAN, HOWARD · 2005 to 2006
$435k
NCRR NIH HHS UL1 RR0249860NCRR NIH HHS UL1 RR025747NCRR NIH HHS UL1 RR025750NCRR NIH HHS UL1 RR029882NCRR NIH HHS UL1 RR05758NIDDK NIH HHS DK063455NIDDK NIH HHS DK063490NIDDK NIH HHS DK063549NIDDK NIH HHS R21 DK070341NIDDK NIH HHS U01 DK063385NIDDK NIH HHS U01-DK063385NIDDK NIH HHS U01 DK063455NIDDK NIH HHS U01 DK063490NIDDK NIH HHS U01 DK063549
6 · The paper itself

Abstract

We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology.

Indexed as

Multicenter Studies as TopicPatient SelectionRandomized Controlled Trials as TopicChild, PreschoolGeographyGlomerulosclerosis, Focal SegmentalHealth PlanningHealth SurveysHumansResearch ReportUnited States

Identifiers

PMID23399084
PMCPMC4698888

What OpenQuestion holds

Textmetadata
LicenceTDM
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.