Original Research

Published on 16 Jun 2022

Characterization of Factors Predicting a Favorable Opinion of Research Applications Submitted for an Ethical Review Process

in Regulatory Science

Eduardo Mirpuri
Lara García-Álvarez
María Teresa Acín-Gericó
Blanca Bartolomé
Roberto C. Delgado Bolton
Montserrat San-Martín
Luis Vivanco

Frontiers in Medicine

doi 10.3389/fmed.2022.878786

1,469 views

Methods

Published on 15 Jun 2022

Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage

in Regulatory Science

Menglu Ouyang
Craig S. Anderson
Lili Song
Alejandra Malavera
Stephen Jan
Guojuan Cheng
Honglin Chu
Xin Hu
Lu Ma
Xiaoying Chen

Frontiers in Medicine

doi 10.3389/fmed.2022.813749

3,441 views
1 citation

Policy and Practice Reviews

Published on 15 Jun 2022

From COVID-19 Pandemic to Patient Safety: A New “Spring” for Telemedicine or a Boomerang Effect?

in Regulatory Science

Francesco De Micco
Vittorio Fineschi
Giuseppe Banfi
Paola Frati
Antonio Oliva
Guido Vittorio Travaini
Mario Picozzi
Giuseppe Curcio
Leandro Pecchia
Tommasangelo Petitti

Frontiers in Medicine

doi 10.3389/fmed.2022.901788

5,165 views
20 citations

Original Research

Published on 14 Jun 2022

A Comparison of Post-marketing Measures Imposed by Regulatory Agencies to Confirm the Tissue-Agnostic Approach

in Regulatory Science

Jorn Mulder
Odile C. van Stuijvenberg
Paula B. van Hennik
Emile E. Voest
Anna M. G. Pasmooij
Violeta Stoyanova-Beninska
Anthonius de Boer

Frontiers in Medicine

doi 10.3389/fmed.2022.893400

3,788 views
5 citations

Original Research

Published on 09 Jun 2022

Back to the Roots of Nursing: Qualitative Study on the Experience of Nurses in the Front Line During the COVID-19 Pandemic

in Regulatory Science

Anna De Benedictis
Raffaella Gualandi
Sabrina Saccoccia
Claudio Pensieri
Michela Piredda
Francesco De Micco
Anna Marchetti
Gabriella Facchinetti
Alessia Assunta Pasquarelli
Chiara De Carolis

Frontiers in Medicine

doi 10.3389/fmed.2022.903517

7,148 views
5 citations

Original Research

Published on 06 Jun 2022

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

in Regulatory Science

Takahiro Sato
Hikaru Ishimaru
Takuya Takata
Hajime Sasaki
Mayumi Shikano

Frontiers in Medicine

doi 10.3389/fmed.2022.903188

3,683 views
5 citations

Original Research

Published on 03 Jun 2022

Social Engagement in the Fight Against COVID-19 in the Urban and Peri-Urban Areas of Cotonou (Benin, Sub-saharan Africa): Acceptability of the Vaccination and Tracking Program

in Regulatory Science

Alessia Maccaro
Davide Piaggio
Iyabosola Busola Oronti
Marius Vignigbé
Antoinette Gbokli
Roch Houngnihin
Leandro Pecchia

Frontiers in Medicine

doi 10.3389/fmed.2022.857890

3,734 views
2 citations

Opinion

Published on 17 May 2022

Existing Knowledge of Medication Error Must Be Better Translated Into Improved Patient Safety

in Regulatory Science

Craig S. Webster

Frontiers in Medicine

doi 10.3389/fmed.2022.870587

4,110 views
9 citations

Original Research

Published on 17 May 2022

Global Research Trends of Gender-Related Artificial Intelligence in Medicine Between 2001–2020: A Bibliometric Study

in Regulatory Science

Ha Young Yoon
Heisook Lee
Jeong Yee
Hye Sun Gwak

Frontiers in Medicine

doi 10.3389/fmed.2022.868040

2,953 views
4 citations

Original Research

Published on 13 May 2022

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

in Regulatory Science

Ki Young Huh
Sang-un Jeong
Seol Ju Moon
Min-Ji Kim
Wooseok Yang
Myeonggyu Jeong
Ildae Song
Yong-Geun Kwak
SeungHwan Lee
Min-Gul Kim

Frontiers in Medicine

doi 10.3389/fmed.2022.837197

2,471 views
13 citations

Perspective

Published on 13 May 2022

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

in Regulatory Science

Laura I. Salazar-Fontana

Frontiers in Medicine

doi 10.3389/fmed.2022.855100

14,304 views
14 citations

Policy and Practice Reviews

Published on 10 May 2022

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

in Regulatory Science

Gabrielle M. O’Sullivan
Joshua G. Philips
Heidi J. Mitchell
Michael Dornbusch
John E. J. Rasko

Frontiers in Medicine

doi 10.3389/fmed.2022.883434

12,222 views
4 citations

Original Research

Published on 06 May 2022

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

in Regulatory Science

Marc Maliepaard
Priscilla Nibi
Gabrièlla Nibi
Anna M. G. Pasmooij

Frontiers in Medicine

doi 10.3389/fmed.2022.893028

6,308 views
4 citations

Original Research

Published on 29 Apr 2022

Assessment of Knowledge Regarding Safety Profile, Use, and Boxed Warnings of Fluoroquinolones Among Healthcare Professionals in Saudi Arabia: A Potential Implication for Drug Regulatory Authorities

in Regulatory Science

Tauqeer Hussain Mallhi
Abdullah Salah Alanazi
Yusra Habib Khan
Nasser Hadal Alotaibi
Muhammad Salman
Abdulaziz Ibrahim Alzarea
Salah-Ud-Din Khan
Nabil K. Alruwaili
Alaa Salah Alenazi
Ahmed D. Alatawi

Frontiers in Medicine

doi 10.3389/fmed.2022.816320

3,388 views
1 citation

Systematic Review

Published on 27 Apr 2022

Non-Pharmacological Interventions for Minimizing Physical Restraints Use in Intensive Care Units: An Umbrella Review

in Regulatory Science

Nianqi Cui
Xiaoli Yan
Yuping Zhang
Dandan Chen
Hui Zhang
Qiong Zheng
Jingfen Jin

Frontiers in Medicine

doi 10.3389/fmed.2022.806945

8,973 views
11 citations

Brief Research Report

Published on 26 Apr 2022

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond

in Regulatory Science

Natalie M. Hendrikse
Jordi Llinares Garcia
Thorsten Vetter
Anthony J. Humphreys
Falk Ehmann

Frontiers in Medicine

doi 10.3389/fmed.2022.878942

5,205 views
11 citations

Navigation group

Articles

Characterization of Factors Predicting a Favorable Opinion of Research Applications Submitted for an Ethical Review Process

Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage

From COVID-19 Pandemic to Patient Safety: A New “Spring” for Telemedicine or a Boomerang Effect?

A Comparison of Post-marketing Measures Imposed by Regulatory Agencies to Confirm the Tissue-Agnostic Approach

Back to the Roots of Nursing: Qualitative Study on the Experience of Nurses in the Front Line During the COVID-19 Pandemic

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations

Social Engagement in the Fight Against COVID-19 in the Urban and Peri-Urban Areas of Cotonou (Benin, Sub-saharan Africa): Acceptability of the Vaccination and Tracking Program

Existing Knowledge of Medication Error Must Be Better Translated Into Improved Patient Safety

Global Research Trends of Gender-Related Artificial Intelligence in Medicine Between 2001–2020: A Bibliometric Study

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

Assessment of Knowledge Regarding Safety Profile, Use, and Boxed Warnings of Fluoroquinolones Among Healthcare Professionals in Saudi Arabia: A Potential Implication for Drug Regulatory Authorities

Non-Pharmacological Interventions for Minimizing Physical Restraints Use in Intensive Care Units: An Umbrella Review

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond