Frontiers in Medicine | Regulatory Science

Original Research

Published on 23 Oct 2023

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities

in Regulatory Science

Lorraine Danks
Boitumelo Semete-Makokotlela
Kennedy Otwombe
Yashmika Parag
Stuart Walker
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2023.1265058

3,258 views
3 citations

Original Research

Published on 12 Oct 2023

Chinese Clinical Trial Registry 13-year data collection and analysis: geographic distribution, financial support, research phase, duration, and disease categories

in Regulatory Science

Ruitai Fan
Yufei Zheng
Runze Zhou
Narasimha M. Beeraka
Olga A. Sukocheva
Ruiwen Zhao
Shijie Li
Xiang Zhao
Chunying Liu
Song He

Frontiers in Medicine

doi 10.3389/fmed.2023.1203346

3,090 views
2 citations

Original Research

Published on 12 Oct 2023

Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey

in Regulatory Science

Jean-Marc Hoffmann
Anette Blümle
Regina Grossmann
Henry Yau
Britta Lang
Cedric Bradbury

Frontiers in Medicine

doi 10.3389/fmed.2023.1252352

2,458 views
2 citations

Original Research

Published on 11 Oct 2023

Analysis of patients’ privacy and associated factors in the perioperative period

in Regulatory Science

Mingyang Tan
Hongyu Li
Xiaofei Wang

Frontiers in Medicine

doi 10.3389/fmed.2023.1242149

3,253 views
1 citation

Original Research

Published on 10 Oct 2023

Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications

in Regulatory Science

Viktoria Lišnić
Hishaam Ashraf
Marin Viđak
Ana Marušić

Frontiers in Medicine

doi 10.3389/fmed.2023.1276847

1,281 views

Perspective

Published on 09 Oct 2023

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program

in Regulatory Science

Meghan Morrison Joly
Terri L. Edwards
Rebecca N. Jerome
Alex Mainor
Gordon R. Bernard
Jill M. Pulley

Frontiers in Medicine

doi 10.3389/fmed.2023.1287449

1,601 views

Opinion

Published on 02 Oct 2023

The nexus of social alliances and diverse moral domains: a bedrock for participatory clinical research

in Regulatory Science

Johanna M. C. Blom
Veronica Rivi
Fabio Tascedda
Luca Pani

Frontiers in Medicine

doi 10.3389/fmed.2023.1250247

1,100 views
1 citation

Policy and Practice Reviews

Published on 22 Sep 2023

Rebalancing commercial and public interests in prioritizing biomedical, social and environmental aspects of health through defining and managing conflicts of interest

in Regulatory Science

Barbara K. Redman

Frontiers in Medicine

doi 10.3389/fmed.2023.1247258

7,535 views
10 citations

Original Research

Published on 21 Sep 2023

Evaluation of medication errors in nursing during the COVID-19 pandemic and their relationship with shift work at teaching hospitals: a cross-sectional study in Iran

in Regulatory Science

Abdolreza Gilavand
Negar Jafarian
Kourosh Zarea

Frontiers in Medicine

doi 10.3389/fmed.2023.1200686

5,779 views
3 citations

Review

Published on 19 Sep 2023

Bibliometric analysis of the current status and trends on medical hyperspectral imaging

in Regulatory Science

Sijia Jiang
Ding Ma
Xin Tan
Mingyu Yang
Qingbin Jiao
Liang Xu

Frontiers in Medicine

doi 10.3389/fmed.2023.1235955

3,273 views
3 citations

Policy and Practice Reviews

Published on 04 Sep 2023

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements

in Regulatory Science

Nevena Miletic
Sarah Adam
Jacqueline Acquah
Zainab Aziz
Angelika Joos
John M. Mwangi

Frontiers in Medicine

doi 10.3389/fmed.2023.1207954

3,715 views
3 citations

Editorial

Published on 25 Aug 2023

Editorial: Managing healthcare transformation towards P5 medicine

in Regulatory Science

Bernd Blobel
Dipak Kalra

Frontiers in Medicine

doi 10.3389/fmed.2023.1244100

1,583 views
3 citations

Original Research

Published on 17 Aug 2023

Inter-rater reliability of the extended Composite Quality Score (CQS-2)

in Regulatory Science

Steffen Mickenautsch
Stefan Rupf
Ivana Miletić
Ulf Tilman Strähle
Richard Sturm
Faheema Kimmie-Dhansay
Kata Vidosusić
Veerasamy Yengopal

Frontiers in Medicine

doi 10.3389/fmed.2023.1201517

1,672 views
3 citations

Systematic Review

Published on 16 Aug 2023

Hospital length of stay prediction tools for all hospital admissions and general medicine populations: systematic review and meta-analysis

in Regulatory Science

Swapna Gokhale
David Taylor
Jaskirath Gill
Yanan Hu
Nikolajs Zeps
Vincent Lequertier
Luis Prado
Helena Teede
Joanne Enticott

Frontiers in Medicine

doi 10.3389/fmed.2023.1192969

4,379 views
10 citations

Mini Review

Published on 07 Aug 2023

Connected health in US, EU, and China: opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development

in Regulatory Science

Susan Awad
Lina Aljuburi
Rebecca S. Lumsden
Marya Mpandzou
Roelie Marinus

Frontiers in Medicine

doi 10.3389/fmed.2023.1248912

2,836 views
4 citations

Perspective

Published on 26 Jul 2023

Walking the talk in digital transformation of regulatory review

in Regulatory Science

Ramy Khalil
Judith C. Macdonald
Andrew Gustafson
Lina Aljuburi
Fabio Bisordi
Ginny Beakes-Read

Frontiers in Medicine

doi 10.3389/fmed.2023.1233142

3,922 views
5 citations

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Articles

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities

Chinese Clinical Trial Registry 13-year data collection and analysis: geographic distribution, financial support, research phase, duration, and disease categories

Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey

Analysis of patients’ privacy and associated factors in the perioperative period

Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program

The nexus of social alliances and diverse moral domains: a bedrock for participatory clinical research

Rebalancing commercial and public interests in prioritizing biomedical, social and environmental aspects of health through defining and managing conflicts of interest

Evaluation of medication errors in nursing during the COVID-19 pandemic and their relationship with shift work at teaching hospitals: a cross-sectional study in Iran

Bibliometric analysis of the current status and trends on medical hyperspectral imaging

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements

Editorial: Managing healthcare transformation towards P5 medicine

Inter-rater reliability of the extended Composite Quality Score (CQS-2)

Hospital length of stay prediction tools for all hospital admissions and general medicine populations: systematic review and meta-analysis

Connected health in US, EU, and China: opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development

Walking the talk in digital transformation of regulatory review