Frontiers in Medicine | Regulatory Science

Methods

Published on 02 May 2024

Application of the Composite Quality Score (CQS-2B) versus Cochrane’s Risk of Bias tool (Version 2) in systematic reviews of clinical trials – an exploratory study

in Regulatory Science

Steffen Mickenautsch
Stefan Rupf
Veerasamy Yengopal

Frontiers in Medicine

doi 10.3389/fmed.2024.1307815

691 views

Brief Research Report

Published on 26 Apr 2024

Promoting opioids, a story about how to influence medical science and opinions

in Regulatory Science

Maud Bernisson
Sergio Sismondo

Frontiers in Medicine

doi 10.3389/fmed.2024.1327939

2,115 views
2 citations

Original Research

Published on 17 Apr 2024

The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

in Regulatory Science

Annalisa Landi
Yanis Mimouni
Viviana Giannuzzi
Franz Schaefer
Annagrazia Altavilla
Spencer Gibson
Daria Julkowska

Frontiers in Medicine

doi 10.3389/fmed.2024.1384026

1,363 views

Mini Review

Published on 12 Apr 2024

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

in Regulatory Science

Kevin Klein
Jens Heisterberg
Pieter Stolk

Frontiers in Medicine

doi 10.3389/fmed.2024.1335928

2,487 views

Perspective

Published on 11 Apr 2024

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products

in Regulatory Science

Luther Gwaza
Andrew Chemwolo
Mario Musonda
Rutendo Kuwana
Admire Dube

Frontiers in Medicine

doi 10.3389/fmed.2024.1394562

1,437 views

Original Research

Published on 10 Apr 2024

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses

in Regulatory Science

Martin Baumgartner
Karl Kreiner
Aaron Lauschensky
Bernhard Jammerbund
Klaus Donsa
Dieter Hayn
Fabian Wiesmüller
Lea Demelius
Robert Modre-Osprian
Sabrina Neururer

Frontiers in Medicine

doi 10.3389/fmed.2024.1301660

3,460 views
1 citation

Original Research

Published on 05 Apr 2024

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation

in Regulatory Science

Claudia P. Alfonso
Guy B. N’Jambong
Alaa Magdy
Laura Di Trapani
Rutendo Kuwana
Abraham G. Kahsay
Diadié Maïga
Sybil N. A. Ossei-Agyeman-Yeboah
Aimé B. Djitafo Fah
Margareth Ndomondo-Sigonda

Frontiers in Medicine

doi 10.3389/fmed.2024.1362253

3,106 views
1 citation

Policy Brief

Published on 02 Apr 2024

Declaration of Helsinki: ethical norm in pursuit of common global goals

in Regulatory Science

Chieko Kurihara
Sandor Kerpel-Fronius
Sander Becker
Anthony Chan
Yasmin Nagaty
Shehla Naseem
Johanna Schenk
Kotone Matsuyama
Varvara Baroutsou

Frontiers in Medicine

doi 10.3389/fmed.2024.1360653

4,523 views
9 citations

Original Research

Published on 28 Mar 2024

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

in Regulatory Science

Viviana Giannuzzi
Arianna Bertolani
Silvia Torretta
Giorgio Reggiardo
Eleonora Toich
Donato Bonifazi
Adriana Ceci

Frontiers in Medicine

doi 10.3389/fmed.2024.1369547

2,564 views
2 citations

Hypothesis and Theory

Published on 28 Mar 2024

Physician’s autonomy in the face of AI support: walking the ethical tightrope

in Regulatory Science

Florian Funer
Urban Wiesing

Frontiers in Medicine

doi 10.3389/fmed.2024.1324963

2,185 views
2 citations

Original Research

Published on 21 Mar 2024

Methodological biases in observational hospital studies of COVID-19 treatment effectiveness: pitfalls and potential

in Regulatory Science

Oksana Martinuka
Derek Hazard
Hamid Reza Marateb
Marjan Mansourian
Miguel Ángel Mañanas
Sergio Romero
Manuel Rubio-Rivas
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1362192

2,706 views
3 citations

Editorial

Published on 18 Mar 2024

Editorial: Current priorities in health research agendas: tensions between public and commercial interests in prioritizing biomedical, social, and environmental aspects of health

in Regulatory Science

Mercedes García Carrillo
Marc-André Gagnon
Matías Blaustein

Frontiers in Medicine

doi 10.3389/fmed.2024.1391982

1,229 views
1 citation

Original Research

Published on 11 Mar 2024

Addressing bias in the definition of SARS-CoV-2 reinfection: implications for underestimation

in Regulatory Science

Hiam Chemaitelly
Houssein H. Ayoub
Patrick Tang
Hadi M. Yassine
Asmaa A. Al Thani
Mohammad R. Hasan
Peter Coyle
Zaina Al-Kanaani
Einas Al-Kuwari
Andrew Jeremijenko

Frontiers in Medicine

doi 10.3389/fmed.2024.1363045

1,883 views
3 citations

Editorial

Published on 08 Mar 2024

Editorial: Women in science - regulatory science 2023

in Regulatory Science

Mette Due Theilade Thomsen
Lisbeth Ehlert Knudsen

Frontiers in Medicine

doi 10.3389/fmed.2024.1389438

1,001 views

Policy and Practice Reviews

Published on 06 Mar 2024

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

in Regulatory Science

Philipp Cimiano
Ben Collins
Maria Carmela De Vuono
Thierry Escudier
Jürgen Gottowik
Matthias Hartung
Mathias Leddin
Bikalpa Neupane
Raul Rodriguez-Esteban
Ana Lucia Schmidt

Frontiers in Medicine

doi 10.3389/fmed.2024.1274688

4,624 views
7 citations

Original Research

Published on 06 Mar 2024

Exploring the divergence in perspectives on clinical trial operations in South Korea during the COVID-19 pandemic: a comparison of a trial site and sponsors

in Regulatory Science

Young-Sang Kim
Anhye Kim
Yil-Seob Lee

Frontiers in Medicine

doi 10.3389/fmed.2024.1342184

2,901 views

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Articles

Application of the Composite Quality Score (CQS-2B) versus Cochrane’s Risk of Bias tool (Version 2) in systematic reviews of clinical trials – an exploratory study

Promoting opioids, a story about how to influence medical science and opinions

The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registries

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products

Health data space nodes for privacy-preserving linkage of medical data to support collaborative secondary analyses

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation

Declaration of Helsinki: ethical norm in pursuit of common global goals

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

Physician’s autonomy in the face of AI support: walking the ethical tightrope

Methodological biases in observational hospital studies of COVID-19 treatment effectiveness: pitfalls and potential

Editorial: Current priorities in health research agendas: tensions between public and commercial interests in prioritizing biomedical, social, and environmental aspects of health

Addressing bias in the definition of SARS-CoV-2 reinfection: implications for underestimation

Editorial: Women in science - regulatory science 2023

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

Exploring the divergence in perspectives on clinical trial operations in South Korea during the COVID-19 pandemic: a comparison of a trial site and sponsors