Frontiers in Medicine | Regulatory Science

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

821 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

1,257 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

1,165 views

Original Research

Published on 05 Jun 2024

Streamlining intersectoral provision of real-world health data: a service platform for improved clinical research and patient care

in Regulatory Science

Katja Hoffmann
Igor Nesterow
Yuan Peng
Elisa Henke
Daniela Barnett
Cigdem Klengel
Mirko Gruhl
Martin Bartos
Frank Nüßler
Richard Gebler

Frontiers in Medicine

doi 10.3389/fmed.2024.1377209

1,751 views
1 citation

Review

Published on 05 Jun 2024

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

in Regulatory Science

Ivana Silva
Giulia Gabrielli
Juan Garcia Burgos
Isabelle Moulon
Gonzalo Calvo Rojas
Ulrich Jaeger
Rosa Giuliani

Frontiers in Medicine

doi 10.3389/fmed.2024.1399947

1,373 views

Review

Published on 03 Jun 2024

Artificial intelligence in healthcare: an Italian perspective on ethical and medico-legal implications

in Regulatory Science

Sara Sablone
Mara Bellino
Andrea Nicola Cardinale
Massimiliano Esposito
Francesco Sessa
Monica Salerno

Frontiers in Medicine

doi 10.3389/fmed.2024.1343456

2,361 views
3 citations

Review

Published on 03 Jun 2024

Navigating the challenges of clinical trial professionals in the healthcare sector

in Regulatory Science

Galo Peralta
Blanca Sánchez-Santiago

Frontiers in Medicine

doi 10.3389/fmed.2024.1400585

19,008 views

Original Research

Published on 31 May 2024

International regulatory and publicly-funded initiatives to advance drug repurposing

in Regulatory Science

Eva Louise Spin
Aukje K. Mantel-Teeuwisse
Anna Maria Gerdina Pasmooij

Frontiers in Medicine

doi 10.3389/fmed.2024.1387517

1,230 views
1 citation

Original Research

Published on 30 May 2024

Current situation and issues regarding termination of risk management plans in Japan

in Regulatory Science

Natsuko Kameyama
Aoi Hosaka
Hideki Maeda

Frontiers in Medicine

doi 10.3389/fmed.2024.1387652

1,224 views
1 citation

Technology and Code

Published on 27 May 2024

Transforming evidence-based clinical guidelines into implementable clinical decision support services: the CAREPATH study for multimorbidity management

in Regulatory Science

Mert Gencturk
Gokce B. Laleci Erturkmen
A. Emre Akpinar
Omid Pournik
Bilal Ahmad
Theodoros N. Arvanitis
Wolfgang Schmidt-Barzynski
Tim Robbins
Ruben Alcantud Corcoles
Pedro Abizanda

Frontiers in Medicine

doi 10.3389/fmed.2024.1386689

2,306 views
1 citation

Review

Published on 23 May 2024

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

in Regulatory Science

Diogo Almeida
Denise Umuhire
Rosa Gonzalez-Quevedo
Ana António
Juan Garcia Burgos
Patrice Verpillat
Nathalie Bere
Bruno Sepodes
Carla Torre

Frontiers in Medicine

doi 10.3389/fmed.2024.1408636

3,974 views

Mini Review

Published on 22 May 2024

Artificial intelligence in drug repurposing for rare diseases: a mini-review

in Regulatory Science

Lucas Cortial
Vincent Montero
Sébastien Tourlet
Joanie Del Bano
Olivier Blin

Frontiers in Medicine

doi 10.3389/fmed.2024.1404338

5,219 views
7 citations

Methods

Published on 16 May 2024

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation

in Regulatory Science

Felix N. Wirth
Hammam Abu Attieh
Fabian Prasser

Frontiers in Medicine

doi 10.3389/fmed.2024.1378866

1,183 views

Original Research

Published on 15 May 2024

Artificial intelligence based data curation: enabling a patient-centric European health data space

in Regulatory Science

Isabelle de Zegher
Kerli Norak
Dominik Steiger
Heimo Müller
Dipak Kalra
Bart Scheenstra
Isabella Cina
Stefan Schulz
Kanimozhi Uma
Petros Kalendralis

Frontiers in Medicine

doi 10.3389/fmed.2024.1365501

4,392 views
2 citations

Mini Review

Published on 13 May 2024

Exploring regulatory flexibility to create novel incentives to optimize drug discovery

in Regulatory Science

Jacqueline A. Sullivan
E. Richard Gold

Frontiers in Medicine

doi 10.3389/fmed.2024.1379966

1,474 views
1 citation

Policy and Practice Reviews

Published on 09 May 2024

Cybersecurity policy framework requirements for the establishment of highly interoperable and interconnected health data spaces

in Regulatory Science

Christian Luidold
Christoph Jungbauer

Frontiers in Medicine

doi 10.3389/fmed.2024.1379852

2,046 views
1 citation

Navigation group

Articles

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

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

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

Streamlining intersectoral provision of real-world health data: a service platform for improved clinical research and patient care

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

Artificial intelligence in healthcare: an Italian perspective on ethical and medico-legal implications

Navigating the challenges of clinical trial professionals in the healthcare sector

International regulatory and publicly-funded initiatives to advance drug repurposing

Current situation and issues regarding termination of risk management plans in Japan

Transforming evidence-based clinical guidelines into implementable clinical decision support services: the CAREPATH study for multimorbidity management

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Artificial intelligence in drug repurposing for rare diseases: a mini-review

OHDSI-compliance: a set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation

Artificial intelligence based data curation: enabling a patient-centric European health data space

Exploring regulatory flexibility to create novel incentives to optimize drug discovery

Cybersecurity policy framework requirements for the establishment of highly interoperable and interconnected health data spaces