Evidence map›Paper›PMID 37099245›Full record

ArticlePharmaceutical medicine2023

A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials.

Andriani C Patera, Julie Maidment, Brijesh Maroj, Ahmed Mohamed, Ken Twomey

Abstract read
In one paragraph

Article in Pharmaceutical medicine, 2023. 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. Article
  2. 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

5 authors.

Andriani C PateraPatient Safety Oncology, Oncology R&D, AstraZeneca, 101 Orchard Ridge Way, Gaithersburg, MD, 20878, USA. andriani.patera@astrazeneca.com.
Julie MaidmentPatient Safety Oncology, Oncology R&D, AstraZeneca, Cambridge, UK.
Brijesh MarojPatient Safety Oncology, Oncology R&D, AstraZeneca, Cambridge, UK.
Ahmed MohamedPatient Safety Oncology, Oncology R&D, AstraZeneca, 101 Orchard Ridge Way, Gaithersburg, MD, 20878, USA.
Ken TwomeyPatient Safety Oncology, Oncology R&D, AstraZeneca, Cambridge, UK.ORCID 0000-0002-9727-7668

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Multiple components factor into the assessment of combination safety risks when two or more novel individual products are used in combination in clinical trials. These include, but are not limited to, biology, biochemistry, pharmacology, class effects, and preclinical and clinical findings (such as adverse drug reactions, drug target and mechanism of action, target expression, signaling, and drug-drug interactions). This paper presents a science-based methodology framework for the assessment of combination safety risks when two or more investigational products are used in clinical trials. The aim of this methodology framework is to improve prediction of the risks, to enable the appropriate safety risk mitigation and management to be put in place for the combination, and the development of the project combination safety strategy.

Indexed as

Clinical Trials as TopicDrug-Related Side Effects and Adverse ReactionsHumansSafety

Identifiers

PMID37099245
PMCPMC10205853

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.