Evidence map›Paper›PMID 25625933›Full record

ReviewHuman vaccines & immunotherapeutics2014

Regulatory considerations for clinical development of cancer vaccines.

Bridget Theresa Heelan

Abstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Personalized Cancer Vaccines: Clinical Landscape, Challenges, and Opportunities.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    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

1 author.

Bridget Theresa Heelana VP (Tech) ; PAREXEL International ; The Quays , UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.

Indexed as

Antigens, NeoplasmCancer VaccinesClinical Trials as TopicEuropean UnionGuidelines as TopicHumansNeoplasmsUnited StatesUnited States Food and Drug AdministrationAntigens, NeoplasmCancer VaccinesAIDS, Acquired Immunodeficiency Syndromeantigenscancer vaccinesCAR, T-cell Chimeric Antigen Receptor T-cellCTL-4, Cytotoxic T-lymphocyte-associated protein 4DCs, Dendritic cellsEBV, Ebstein Barr VirusEMA, European Medicines AgencyEU, European UnionFDA, Federal Drug AdministrationHHV-8, Human Herpes Virus 8HTA, Health Technology AssessmentICH, International Conference on HarmonisationICI, Immune Checkpoint Inhibitorsimmunesurveillanceimmune systemITF, Innovation Task ForceMDSC, Myeloid-derived suppressor cellsMHRA, Medicines and Healthcare products Regulatory AgencyMUC1, Membrane-bound glycoprotein MUC1 mucinNICE, National Institute for Heath and Care excellenceOS, Overall survivalPD-1, Programmed cell death 1PD, PharmacodynamicPFS, Progression-free survivalPMDA, Pharmaceutical and Medical Devices AgencyPTLD, Post-transplant lymphoproliferative diseaseRECIST, Response Evaluation Criteria in Solid TumorsSerum Igs, Serum immunoglobulinssiRNA, Small interfering RNATAA, Tumor associated antigensT cellsTIMs, Tumor Infiltrating Myeloid CellTregs, Regulatory T cellsUS, United States of America

Identifiers

PMID25625933
PMCPMC4514046

What OpenQuestion holds

Textmetadata
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.