Evidence map›Paper›PMID 27598744›Full record

ReviewInflammatory bowel diseases2017

Investigator-Initiated IBD Trials in the United States: Facts, Obstacles, and Answers.

Hans H Herfarth, Susan Jackson, Barbara G Schliebe, Christopher Martin, Anastasia Ivanova, Kristen Anton, Robert S Sandler, Millie D Long, Kim L Isaacs, Mark T Osterman and 3 more

Abstract readReview
In one paragraph

Review in Inflammatory bowel diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. 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

13 authors.

Hans H Herfarth*Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina; †CGIBD Biostatistics Core, University of North Carolina, Chapel Hill, North Carolina; ‡Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; §Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; ‖Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania; ¶Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; #Division of Gastroenterology and Hepatology, Michigan, Indiana; and **Center for Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.
Susan Jackson
Barbara G Schliebe
Christopher Martin
Anastasia Ivanova
Kristen Anton
Robert S Sandler
Millie D Long
Kim L Isaacs
Mark T Osterman
Bruce E Sands
Peter D Higgins
James D Lewis

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
MEthotrexate Response in Treatment of UC - MERIT-UCU01DK092239 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HERFARTH, HANS H. · 2011 to 2015
$8.2M
NIDDK NIH HHS P30 DK034987NIDDK NIH HHS U01 DK092239
6 · The paper itself

Abstract

Investigator-initiated randomized clinical trials are the backbone of academic clinical research. Investigator-initiated trials (IITs) complement the large clinical studies sponsored by industry and address questions, which are usually not the main focus of a commercially directed research but have the purpose to confirm, improve, or refute clinically important questions with regard to diagnostic and therapeutic approaches in patient care. The aim of this review is to illustrate the necessary steps to start and complete an IIT in the field of inflammatory bowel diseases in the United States. The initial milestones for an investigator include structuring a protocol, planning and building of the trial infrastructure, accurately estimating the costs of the trial, and gauging the time span for recruitment. Once the trial has begun it is important to keep patient recruitment on target, monitor of the data quality, and document treatment emergent adverse events. This article provides a framework for the different phases of an IIT and outlines potential hurdles, which could hinder a successful execution.

Indexed as

Clinical ProtocolsInflammatory Bowel DiseasesResearch PersonnelHumansRandomized Controlled Trials as TopicUnited States

Identifiers

PMID27598744
PMCPMC5177501

What OpenQuestion holds

Textmetadata
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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.