Results 1 to 10 of about 27,021 (267)

RWD-Cockpit: Application for Quality Assessment of Real-world Data

JMIR Formative Research, 2022
BackgroundDigital technologies are transforming the health care system. A large part of information is generated as real-world data (RWD).
Lmar Marie Babrak, Erand Smakaj, Teyfik Agac, Petra Maria Asprion, Frank Grimberg, Daan Van der Werf, Erwin Willem van Ginkel, Deniz David Tosoni, Ieuan Clay, Markus Degen, Dominique Brodbeck, Eriberto Noel Natali, Erik Schkommodau, Enkelejda Miho   +13 more
doaj   +4 more sources

Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings [PDF]

Frontiers in Drug Safety and Regulation
The evolving regulatory landscape has increasingly recognized the value of real-world data (RWD) in enhancing drug safety surveillance across the clinical development lifecycle.
Kathleen M. Gavin, Matthew L. Sundermann, Alethea Wieland   +2 more
doaj   +2 more sources

Use of real-world data and real-world evidence in NICE (UK) health technology appraisals of new therapeutics in oncology: a systematic review [PDF]

BMJ Open
Objectives To quantify and describe the use of real-world data (RWD) in National Institute for Health and Care Excellence (NICE) oncology technology appraisal (TA) final appraisal determination documents.Design A systematic literature review was ...
Lewis Carpenter, Amy MacDougall, Filipa Tunaru, Danielle E Robinson   +3 more
doaj   +2 more sources

sFlt-1/PlGF ratio for prediction of preeclampsia in clinical routine: A pragmatic real-world analysis of healthcare resource utilisation.

PLoS ONE, 2022
BackgroundWe investigated the impact of the soluble fms-like tyrosine kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio to predict short-term risk of preeclampsia on clinical utility and healthcare resource utilisation using real-world data (RWD ...
Anne Dathan-Stumpf, Anna Rieger, Stefan Verlohren, Cyrill Wolf, Holger Stepan   +4 more
doaj   +2 more sources

Transferability of real-world data across borders for regulatory and health technology assessment decision-making

Frontiers in Medicine, 2022
Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making.
Ashley Jaksa, Patrick J. Arena, Patrick J. Arena, Kelvin K. W. Chan, Kelvin K. W. Chan, Rami H. Ben-Joseph, Páll Jónsson, Ulka B. Campbell   +7 more
doaj   +1 more source

The Real-World Data Challenges Radar: A Review on the Challenges and Risks regarding the Use of Real-World Data

Digital Biomarkers, 2021
Background: The life science industry has a strong interest in real-world data (RWD), a term that is currently being used in many ways and with varying definitions depending on the source.
Frank Grimberg, Petra Maria Asprion, Bettina Schneider, Enkelejda Miho, Lmar Babrak, Ali Habbabeh   +5 more
doaj   +1 more source

Parental Perspectives on Their Grade 4 Children with Reading and Writing Difficulties in Mainstream Government Schools in Mauritius

International Journal of Education, 2021
Reading and writing difficulties (RWD) in learners pose significant challenges not just for children but also for parents. While there is limited support available for children with RWD and their parents in Mauritian schools, research may reveal areas of
Sattiavany Veerabudren, Alta Kritzinger, Marien Graham, Salomé Geertsema, Mia le Roux   +4 more
doaj   +1 more source

RWD-derived response in multiple myeloma

PLOS ONE, 2023
Real-world data (RWD) are important for understanding the treatment course and response patterns of patients with multiple myeloma. This exploratory pilot study establishes a way to reliably assess response from incomplete laboratory measurements captured in RWD. A rule-based algorithm, adapted from International Myeloma Working Group response criteria,
Tao Xu, James Roose, Mellissa Williamson, Ahmed Sawas, Wan-Jen Hong, Huan Jin, Kathleen Maignan, Alberto Rocci, Kasra Yousefi, Shaji Kumar, Stefka Tyanova   +10 more
openaire   +3 more sources

Real World Data in Health Technology Assessment of Complex Health Technologies

Frontiers in Pharmacology, 2022
The available evidence on relative effectiveness and risks of new health technologies is often limited at the time of health technology assessment (HTA). Additionally, a wide variety in real-world data (RWD) policies exist among HTA organizations.
Milou A. Hogervorst, Milou A. Hogervorst, Johan Pontén, Rick A. Vreman, Rick A. Vreman, Aukje K. Mantel-Teeuwisse, Wim G. Goettsch, Wim G. Goettsch   +7 more
doaj   +1 more source

The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making

Breast, 2022
Among stakeholders and decision-makers in advanced breast cancer, the demand for insights from real-world data (RWD) is increasing. Although RWD can be used to support decisions throughout different stages of a breast cancer drug's life cycle, barriers ...
Paul Cottu, Scott David Ramsey, Oriol Solà-Morales, Patricia A. Spears, Lockwood Taylor   +4 more
doaj   +1 more source