Evidence map›Paper›PMID 34711500›Full record

ArticleCytotherapy2022

Alignment of practices for data harmonization across multi-center cell therapy trials: a report from the Consortium for Pediatric Cellular Immunotherapy.

Hisham Abdel-Azim, Hema Dave, Kimberly Jordan, Stephanie Rawlings-Rhea, Annie Luong, Ashley L Wilson

Open access · bronzeAbstract read
In one paragraph

Article in Cytotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 41% of its field
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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
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 at 4 institutions in 1 country.

Hisham Abdel-AzimCancer and Blood Disease Institute, Children's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Hema DaveCenter for Cancer and Blood Disorders, Children's National Hospital, George Washington School of Medicine, Washington, DC, USA.
Kimberly JordanDepartment of Immunology and Microbiology, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.
Stephanie Rawlings-RheaSeattle Children's Therapeutics, Seattle Children's Research Institute, Seattle, Washington, USA.
Annie LuongCancer and Blood Disease Institute, Children's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Ashley L WilsonSeattle Children's Therapeutics, Seattle Children's Research Institute, Seattle, Washington, USA. Electronic address: ashley.wilson2@seattlechildrens.org.
University of Southern California · USCenter for Cancer and Blood Disorders · USSeattle Children's Hospital · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Prospective evaluation of barriers to patient referral and enrollment in emerging cellular therapy trials: determining methods and structure to improve equity in future trial designU01TR002487 · NCATS · SEATTLE CHILDREN'S HOSPITAL · PI PARK, JULIE R, RAMSEY, BONNIE W · 2018 to 2022
$7.2M
NCATS NIH HHS U01 TR002487
6 · The paper itself

Abstract

Immune effector cell (IEC) therapies have revolutionized our approach to relapsed B-cell malignancies, and interest in the investigational use of IECs is rapidly expanding into other diseases. Current challenges in the analysis of IEC therapies include small sample sizes, limited access to clinical trials and a paucity of predictive biomarkers of efficacy and toxicity associated with IEC therapies. Retrospective and prospective multi-center cell therapy trials can assist in overcoming these barriers through harmonization of clinical endpoints and correlative assays for immune monitoring, allowing additional cross-trial analysis to identify biomarkers of failure and success. The Consortium for Pediatric Cellular Immunotherapy (CPCI) offers a unique platform to address the aforementioned challenges by delivering cutting-edge cell and gene therapies for children through multi-center clinical trials. Here the authors discuss some of the important pre-analytic variables, such as biospecimen collection and initial processing procedures, that affect biomarker assays commonly used in IEC trials across participating CPCI sites. The authors review the recent literature and provide data to support recommendations for alignment and standardization of practices that can affect flow cytometry assays measuring immune effector function as well as interpretation of cytokine/chemokine data. The authors also identify critical gaps that often make parallel comparisons between trials difficult or impossible.

Indexed as

ImmunotherapyNeoplasm Recurrence, LocalCell- and Tissue-Based TherapyChildHumansProspective StudiesRetrospective StudiesbiomarkersCAR Tcellular therapycorrelative studiesharmonizationimmunotherapy

Identifiers

PMID34711500
PMCPMC8792313
OpenAlexW3209702361

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.