Evidence map›Paper›PMID 40476949›Full record

ArticleNeuroscience applied2023

Conducting CNS trials during a public health emergency - Lessons learned from the COVID-19 pandemic: A joint ISCTM/ECNP working group consensus paper.

Kemi Olugemo, Dragana Bugarski-Kirola, Gerard R Dawson, Franco DiCesare, Dejan Stevanović, Janko Samardzic, Andreas Chatzittofis, Raeanne Moore, Joris C Verster, Lais Bhering and 1 more

Abstract read
In one paragraph

Article in Neuroscience applied, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Kemi OlugemoInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Dragana Bugarski-KirolaInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Gerard R DawsonEuropean College of Neuropsychopharmacology (ECNP), Utrecht, the Netherlands.
Franco DiCesareEuropean College of Neuropsychopharmacology (ECNP), Utrecht, the Netherlands.
Dejan StevanovićInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Janko SamardzicEuropean College of Neuropsychopharmacology (ECNP), Utrecht, the Netherlands.
Andreas ChatzittofisEuropean College of Neuropsychopharmacology (ECNP), Utrecht, the Netherlands.
Raeanne MooreInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Joris C VersterInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Lais BheringInternational Society of CNS Clinical Trials and Methodology (ISCTM), Nashville, Tennessee, USA.
Eduard VietaEuropean College of Neuropsychopharmacology (ECNP), Utrecht, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A joint working group between the International Society of CNS Clinical Trials and Methodology (ISCTM) and the European College of Neuropsychopharmacology (ECNP) was formed in the latter part of 2020 to explore possible ways to mitigate the impact of Coronavirus disease-19 (COVID-19) in clinical trials while attempting to advance approaches and capabilities to bring new therapeutics to patients. The working group was tasked with developing guidelines for trial design modifications to assist sponsor companies in minimizing risks to data integrity, with a focus on regulatory, technological, operational, and methodological issues related to COVID-19. To facilitate focused and transferable recommendations, three disease categories were selected as examples to demonstrate the breadth of solutions implemented across CNS clinical trials, as well as ongoing challenges. The categories studied reflected the interests and expertise of the working group, and included neurodegenerative diseases and dementia, mental health disorders, and rare/pediatric diseases. Herein, we describe interim recommendations from the working group as well as priorities for future public health emergencies, to inform permanent adoption in CNS clinical trial development and conduct.

Indexed as

COVID-19ECNPISCTMMethodologyNeuroscienceWorking group

Identifiers

PMID40476949
PMCPMC10275769

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.