Results 171 to 180 of about 223,149 (252)

Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions. [PDF]

Clin Transl Sci
Kim E, Bae S, Huh KY, Lee S, Shin W, Yoo H, Gu N, Kim A.   +7 more
europepmc   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

When the system fails, the community leads: field insights from the self-efficacy and knowledge (SEEK) trial during Lebanon's 2024 active conflict. [PDF]

Confl Health
Saleh S, Naal H, Chamseddine Z, Sarieddine D, Govender V, Bosqui T, Honein-AbouHaidar G, Tamim H, Fouad F, Say L, Dakdouki AE.   +10 more
europepmc   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Feasibility of Home-Based Spirometry Monitoring as a Decentralized Clinical Trial Component in Patients with Chronic Obstructive Pulmonary Disease and Other Respiratory Diseases. [PDF]

Healthcare (Basel)
Park YC, Kim SY, Hong G, Hong JH, Park D, Sunwoo J.   +5 more
europepmc   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

Evaluation of Decentralized Solid Waste Management in the Thiruvananthapuram Corporation Area in Kerala, India. [PDF]

Cureus
D S D, G N, S H.
europepmc   +1 more source

Publicly funded private schools and academic achievement: A comparative analysis of PISA data in European countries

British Educational Research Journal, EarlyView.
Abstract This paper analyses differences in academic achievement associated with attendance at publicly funded private schools and public schools across 11 European countries. Using eight waves of PISA data (2000–2022), we apply OLS, IPW and IPWRA estimators to account for observed heterogeneity and mitigate selection bias.
Priya Maurya, Léonard Moulin, Denis Fougère   +2 more
wiley   +1 more source

Cost and cost-effectiveness of alternative screening and diagnostic pathways for achieving hepatitis C elimination in the country of Georgia. [PDF]

PLOS Glob Public Health
Walker JG, Tskhomelidze Schumacher I, Shadaker S, Gabunia T, Tohme RA, Abutidze A, Getia V, Vickerman P.   +7 more
europepmc   +1 more source

‘Self’ and ‘othering’ as a byproduct of large‐scale assessment: An investigation into the Gaokao retake policy

British Educational Research Journal, EarlyView.
Abstract While Gaokao, the National College Entrance Examination (NCEE), has been extensively discussed outside the Chinese academic circle, the retake policy of the test has not received much attention. Moreover, Gaokao research in China has predominantly examined the effectiveness of the retake decision in relation to students' demographic ...
Yifeng Cheng, M. Obaidul Hamid
wiley   +1 more source