Evidence map›Paper›PMID 25949926›Full record

ArticleTherapeutic innovation & regulatory science2013

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.

Frederick Curro, Van P Thompson, Frederick Naftolin, Ashley Grill, Don Vena, Louis Terracio, Mariko Hashimoto, Matthew Buchholz, Andrea McKinstry, Diane Cannon and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2013. 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

14 authors.

Frederick CurroPEARL Executive Management Team, New York University, College of Dentistry, 380 2nd Ave, Suite 302, New York, NY.
Van P ThompsonPEARL Executive Management Team, New York University, College of Dentistry, 380 2nd Ave, Suite 302, New York, NY.
Frederick NaftolinMedical Director PEARL Network, NYU School of Medicine. New York, NY.
Ashley GrillPEARL Information Core Coordinator, New York University, College of Dentistry. New York, NY.
Don VenaPEARL Executive Management Team, PEARL Coordinating Center Principal Investigator, EMMES Corporation, Rockville, Maryland.
Louis TerracioVice Dean of Research, and PEARL Executive Management Team, New York University, College of Dentistry, New York, NY.
Mariko HashimotoPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Matthew BuchholzPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Andrea McKinstryPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Diane CannonPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Vincent AlfanoPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Thalia GoodenPEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
Anthony VernilloProfessor, Department Oral & Maxillofacial Pathology, Radiology & Medicine, New York University College of Dentistry, New York, NY.
Elan CzeislerDirector of NYU School of Medicine IRB. New York, NY.

Funding

Practitioners Engaged in Applied Research and LearningU01DE016755 · NIDCR · NEW YORK UNIVERSITY · PI CURRO, FREDERICK ANTHONY · 2005 to 2011
$17.3M
NIDCR NIH HHS U01 DE016755
6 · The paper itself

Abstract

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Identifiers

PMID25949926
PMCPMC4418503

What OpenQuestion holds

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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.