Advancing the regulation of traditional and complementary medicine products: A comparison of five regulatory systems on traditional medicines with a long history of …

Z Liang, H Hu, J Li, D Yao, Y Wang… - Evidence‐Based …, 2021 - Wiley Online Library
Background. An appropriate regulatory system to ensure and promote the quality, safety,
and efficacy of the products of traditional medicine (TM) and complementary medicine (CM) …

Effect of nusinersen on motor, respiratory and bulbar function in early-onset spinal muscular atrophy

A Pechmann, M Behrens, K Dörnbrack, A Tassoni… - Brain, 2023 - academic.oup.com
Abstract 5q-associated spinal muscular atrophy is a rare neuromuscular disorder with the
leading symptom of a proximal muscle weakness. Three different drugs have been …

European health data space—An opportunity now to grasp the future of data-driven healthcare

D Horgan, M Hajduch, M Vrana, J Soderberg… - Healthcare, 2022 - mdpi.com
The May 2022 proposal from the European commission for a 'European health data
space'envisages advantages for health from exploiting the growing mass of health data in …

Tactical Considerations for Designing Real-World Studies: Fit-for-Purpose Designs That Bridge Research and Practice

NA Dreyer, CD Mack - Pragmatic and Observational Research, 2023 - Taylor & Francis
Real-world evidence (RWE) is being used to provide information on diverse groups of
patients who may be highly impacted by disease but are not typically studied in traditional …

Real-world and regulatory perspectives of artificial intelligence in cardiovascular imaging

E Wellnhofer - Frontiers in Cardiovascular Medicine, 2022 - frontiersin.org
Recent progress in digital health data recording, advances in computing power, and
methodological approaches that extract information from data as artificial intelligence are …

Overcoming personal information protection challenges involving real-world data to support public health efforts in China

Y Yao, F Yang - Frontiers in Public Health, 2023 - frontiersin.org
In the information age, real-world data-based evidence can help extrapolate and
supplement data from randomized controlled trials, which can benefit clinical trials and drug …

Effect of statins on all-cause mortality in adults: A systematic review and meta-analysis of propensity score-matched studies

MM Nowak, M Niemczyk, M Florczyk… - Journal of Clinical …, 2022 - mdpi.com
Statins are lipid-lowering medications used for the prevention of cardiovascular disease
(CVD), but the pleiotropic effects of statins might be beneficial in other chronic diseases. This …

[HTML][HTML] Young adult depression, antidepressant prescriptions, and therapy intensification in people with incident depression in the United States

J Dibato, O Montvida, WH Polonsky… - The Primary Care …, 2022 - psychiatrist.com
Objective: To evaluate the temporal trend in young adult depression, prescription patterns of
first-and second-line antidepressants, and factors influencing therapy intensification for …

[HTML][HTML] Значение исследований реальной клинической практики в оценке технологий здравоохранения

ЕА Новодережкина, СК Зырянов - Фармакоэкономика …, 2022 - cyberleninka.ru
В современном мире область данных, собираемых в условиях реальной клинической
практики (РКП; англ. real world data, RWD), а также доказательств, получаемых путем …

The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European …

R Jandhyala - Journal of Pharmaceutical Policy and Practice, 2022 - Springer
Background Despite calls for the use of additional real-world evidence (RWE) during drug
development, rates of inclusion at the regulatory stage remain low. The medicine adoption …