ArticleBMJ open2019
Systematic review protocol: an assessment of the post-approval challenges of autologous CAR-T therapy delivery.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review of economic evaluations of advanced therapy medicinal products.British journal of clinical pharmacology · 2021Pooled it
- Understanding the Feasibility of Implementing CAR T-Cell Therapies from a Canadian Perspective.Healthcare policy = Politiques de sante · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFollowing recent regulatory approvals of two chimeric antigen receptor T-cell (CAR-T) therapies, the field now faces a number of post-approval challenges. These challenges are in some respects defined and, in others, uncertain due to the nascence of the field. At present, information pertaining to such post-approval challenges are scattered in various previous reviews or raised in singular papers reporting experience in working with the therapy. This systematic review is designed to evaluate and summarise the post-approval challenges for robust delivery of CAR-T therapies to inform future work on the optimisation of CAR-T delivery to patients. METHODS AND ANALYSIS: We will search Medline, EMBASE (OvidSP), BIOSIS & Web of Science, Cochrane Library, ICER database, NICE Evidence Search, CEA Registry, WHOLIS WHO Library and Scopus for studies published between 2014 and the present. In addition, a Google search for grey literature such as bioprocess blog posts, opinion pieces, press releases and listed companies involved in CAR-T development annual reports will be conducted. Two authors will independently screen the titles and abstracts identified from the search and accept or reject the studies according to the study inclusion criteria and any discrepancies will be discussed and resolved. The quality of the selected literature will be assessed using the Critical Appraisal Skills Programme(CASP) Systematic Review checklist and grey literature will be assessed using the Authority, Accuracy, Coverage, Objectivity, Date, Significance (AACODS) checklist. Data from eligible publications will be categorised using a flowchart and extracted using a data abstraction form. Qualitative and quantitative analysis of the post-approval challenges of CAR-T therapies will be conducted based on the results attained. ETHICS AND DISSEMINATION: The executed study will be published in a peer-reviewed journal in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The findings from this review will be used to inform the development of an optimisation model for robust delivery of CAR-T therapies using a systems engineering approach. TRIAL REGISTRATION NUMBER: CRD42018109756.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.