Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:
Brexit
- Speed Dating in the UK? Negotiating New Data Protection Relationships with the EU (28 oktober 2020). LexBlog.
- Guidance Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021 (last updated 27 oktober 2020). Medicines and Healthcare products Regulatory Agency.
COVID-19
- Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: A report from the Innovative Therapies for Children with Cancer (ITCC) consortium (december 2020). European Journal of Cancer.
- EMA outlines regulatory transparency measures amid COVID pandemic (30 oktober 2020). Regulatory Focus.
- Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development (29 oktober 2020). PNAS.
- The ‘very, very bad look’ of remdesivir, the first FDA-approved COVID-19 drug (28 oktober 2020). Science.
- Recommended Checklist for Research Communities During the COVID-19 Pandemic (oktober 2020). UK Research Integrity Office.
- Researchers publish the same COVID-19 paper three times (29 oktober 2020). Retraction Watch.
- Analyze Data Validity to Identify Impact of COVID-19 Disruptions, Expert Says (26 oktober 2020). WCG CenterWatch.
- FDA Advisory Committee to Develop Master Protocols for COVID-19 Vaccines (26 oktober 2020). WCG CenterWatch.
- Watch: mRNA vaccines face their first test in the fight against Covid-19. How do they work? (26 oktober 2020). STAT.
- Binnen drie uur 10.000 aanmeldingen Limburgs corona-onderzoek (23 oktober 2020). Skipr.
- Vaccines 101: How new vaccines are developed (28 september 2020). Nature, via YouTube.
- Immuno-oncology drug development forges on despite COVID-19 (18 september 2020). Nature.
- Russian Covid-19 vaccine data raises questions (11 september 2020). Chemistry World.
Dierexperimenteel onderzoek
Dutch Oncology Research Platform (DORP)
- Clinical Trial Roadmap is compleet (27 oktober 2020).
- Waarom een statisticus vroeg in een studie betrekken? (27 oktober 2020).
EQUATOR Network
- What is the little thing you can do to increase reproducibility, replicability and trust in science? (5 oktober 2020).
- Why did we develop TIDieR-Placebo? (29 september 2020).
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
Ministerie van Economische Zaken en Klimaat & Ministerie van Onderwijs, Cultuur en Wetenschap
Overig nieuws
- Pharmafocus (November 2020).
- ‘Patient friction coefficient’ can gauge the burden of participating in a clinical trial (30 oktober 2020). STAT.
- Euro Convergence: Early consultation critical in overcoming gene therapy hurdles (30 oktober 2020). Regulatory Focus.
- The Stressful Conclusion of a Clinical Trial (29 oktober 2020). The New York Times.
- Wealthy funder pays reparations for use of HeLa cells (29 oktober 2020). Nature.
- Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges (29 oktober 2020).
- There’s a silent crisis in clinical research. And it’s not Covid-19 (28 oktober 2020). STAT.
- Euro Convergence: Pragmatic approaches to data collection needed to meet MDR (28 oktober 2020). Regulatory Focus.
- Study bystanders and ethical treatment of study participants—A proof of concept (26 oktober 2020). Bioethics.
- Prof. Peter Mol: Bringing regulatory science closer to the shop floor (19 oktober 2020). Regulatory Science, edition 11.
- US ex-doctor who ran fraudulent clinical trial sites is sentenced to 28 years in prison (12-10-2020). BMJ.
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