Evidence map›Paper›PMID 28293909›Full record

ReviewCurrent allergy and asthma reports2017

Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles.

Harold S Nelson, Moises A Calderon, David I Bernstein, Thomas B Casale, Stephen R Durham, Jens S Andersen, Robert Esch, Linda S Cox, Hendrik Nolte

Abstract readReview
PubMed Publisher
In one paragraph

Review in Current allergy and asthma reports, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2021
    Article
  5. Clinical and immunological evaluation of cat-allergic asthmatics living with or without a cat.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2021
    Article
  6. 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

9 authors.

Harold S NelsonNational Jewish Health, 1400 Jackson St, Denver, CO, 80206, USA. nelsonh@njhealth.org.
Moises A CalderonRoyal Brompton and Harefield Hospitals NHS Trust and Imperial College London, London, UK.
David I BernsteinUniversity of Cincinnati College of Medicine and Bernstein Allergy Group, Cincinnati, OH, USA.
Thomas B CasaleUniversity of South Florida Morsani College of Medicine, Tampa, FL, USA.
Stephen R DurhamRoyal Brompton and Harefield Hospitals NHS Trust and Imperial College London, London, UK.
Jens S AndersenALK, Horsholm, Denmark.
Robert EschSchool of Natural Sciences, Lenoir-Rhyne University, Hickory, NC, USA.
Linda S CoxAllergy and Asthma Center, Ft Lauderdale, FL, USA.
Hendrik NolteALK, Horsholm, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Progress has been made in the harmonization of efficacy and safety outcome measures for allergen immunotherapy (AIT) trials, but unresolved issues still remain. Furthermore, there are discrepancies in recommendations from professional medical societies and regulatory agencies regarding requirements for AIT trials. In this article, we reviewed published recommendations and current data from recent clinical trials, as well as the criteria applied by regulatory authorities for approval of AIT products, to provide updated considerations for conducting phase 3 AIT trials. Topics discussed include analysis of outcomes and trial designs for pediatric and asthma indications, as well as trial designs for perennial allergic rhinoconjunctivitis. In addition, the need for harmonization of safety reporting is emphasized. Considerations presented in this article may further effort to find common ground among professional medical societies and government agencies in developing future recommendations for AIT trial design.

Indexed as

Clinical Trials as TopicAllergensAsthmaDesensitization, ImmunologicHumansResearch DesignRhinitis, AllergicAllergensAllergic rhinitisImmunotherapy and tolerance inductionRegulatory aspectsTrial design

Identifiers

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.