Frontiers in Medicine | Regulatory Science

Original Research

Published on 17 Jul 2024

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

in Regulatory Science

Joyce M. Hoek
Jonna Brenninkmeijer
Ymkje Anna de Vries
Rob R. Meijer
Don van Ravenzwaaij

Frontiers in Medicine

doi 10.3389/fmed.2024.1409259

1,037 views
1 citation

Policy Brief

Published on 17 Jul 2024

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

in Regulatory Science

Ciara Staunton
Johanna M. C. Blom
Deborah Mascalzoni
on behalf of the IMI FACILITATE Consortium

Frontiers in Medicine

doi 10.3389/fmed.2024.1408600

1,309 views

Original Research

Published on 16 Jul 2024

A reference architecture for personal health data spaces using decentralized content-addressable storage networks

in Regulatory Science

Toomas Klementi
Gunnar Piho
Peeter Ross

Frontiers in Medicine

doi 10.3389/fmed.2024.1411013

1,937 views
4 citations

Review

Published on 10 Jul 2024

A comprehensive analysis of digital health-focused Living Labs: innovative approaches to dementia

in Regulatory Science

Teodora Figueiredo
Luís Midão
Joana Carrilho
Diogo Videira Henriques
Sara Alves
Natália Duarte
Maria João Bessa
José María Fidalgo
Maria García
David Facal

Frontiers in Medicine

doi 10.3389/fmed.2024.1418612

1,694 views

Original Research

Published on 05 Jul 2024

Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register

in Regulatory Science

Anwesha Dhal Samanta
Rishima Borah
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1357930

883 views

Opinion

Published on 03 Jul 2024

Enhancing the quality and efficiency of regulatory science literature reviews through innovation and collaboration with library and information science experts

in Regulatory Science

Elizabeth R. Stevens
Gregory Laynor

Frontiers in Medicine

doi 10.3389/fmed.2024.1434427

1,299 views
1 citation

Original Research

Published on 03 Jul 2024

One hundred years of Ecuadorian biomedical scientific output and its association with the main causes of mortality: a bibliometric study

in Regulatory Science

Ivan Sisa
Jhon Caicedo-Potosí
María Cordovez
Clara Verdezoto
Mishell Barreno
Martín Coral
Gricelda Herrera-Franco

Frontiers in Medicine

doi 10.3389/fmed.2024.1395433

3,896 views
1 citation

Original Research

Published on 01 Jul 2024

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

in Regulatory Science

Yong Yang
Rui Jiang
Gengliang Bai
Qingqing Liu
Yongfa Chen

Frontiers in Medicine

doi 10.3389/fmed.2024.1409270

860 views

Original Research

Published on 27 Jun 2024

Showcasing the Saudi e-referral system experience: the epidemiology and pattern of referrals utilising nationwide secondary data

in Regulatory Science

Nawfal A. Aljerian
Abdullah A. Alharbi
Reem S. AlOmar
Meshary S. Binhotan
Hani A. Alghamdi
Mohammed S. Arafat
Abdulrahman Aldhabib
Mohammed K. Alabdulaali

Frontiers in Medicine

doi 10.3389/fmed.2024.1348442

3,074 views
2 citations

Policy Brief

Published on 24 Jun 2024

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

in Regulatory Science

Mariia V. Maksimova
Ghislaine J. M. W. van Thiel
Yke Tromp
Rosan Lechner
Johannes J. M. van Delden
Lourens T. Bloem

Frontiers in Medicine

doi 10.3389/fmed.2024.1408553

1,525 views
2 citations

Systematic Review

Published on 21 Jun 2024

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America

in Regulatory Science

Harold M. Farfán-Vargas
Dante Espinoza-Morriberon
Marcia M. Moya-Salazar
Hans Contreras-Pulache
Jeel Moya-Salazar

Frontiers in Medicine

doi 10.3389/fmed.2024.1281199

2,728 views

Original Research

Published on 17 Jun 2024

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

in Regulatory Science

John Owen
Anando Sen
Beate Aurich
Corinna Engel
Giacomo Cavallaro
Eva Degraeuwe
Dipak Kalra
Ronald Cornet
Melissa Walsh
Teresa Berkery

Frontiers in Medicine

doi 10.3389/fmed.2024.1370916

2,077 views
2 citations

Original Research

Published on 17 Jun 2024

Lessons learned: avoiding bias via multi-state analysis of patients’ trajectories in real-time

in Regulatory Science

Elisabeth Lucke
Derek Hazard
Marlon Grodd
Susanne Weber
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1390549

1,199 views

Original Research

Published on 12 Jun 2024

Protection from prior natural infection vs. vaccination against SARS-CoV-2—a statistical note to avoid biased interpretation

in Regulatory Science

Susanne Weber
Pontus Hedberg
Pontus Naucler
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1376275

909 views

Mini Review

Published on 10 Jun 2024

New clinical insight in amyotrophic lateral sclerosis and innovative clinical development from the non-profit repurposing trial of the old drug guanabenz

in Regulatory Science

Anna Ambrosini
Eleonora Dalla Bella
Maddalena Ravasi
Mario Melazzini
Giuseppe Lauria

Frontiers in Medicine

doi 10.3389/fmed.2024.1407912

1,393 views

Brief Research Report

Published on 05 Jun 2024

Clinical development and marketing application review times for novel orphan-designated drugs

in Regulatory Science

Ebru Demirci
Jennifer Knicley
Lori Fiorentino

Frontiers in Medicine

doi 10.3389/fmed.2024.1404922

1,289 views