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Algemene verordening gegevensbescherming (AVG), Privacy
Centrale Commissie Dierproeven (CCD)
Clinical trials
- NIH aims to boost diversity in Alzheimer’s disease trials with online tech (24 augustus 2021). Clinical Insider.
- Planning key to mastering digital master trials, researchers (23 augustus 2021). Clinical Insider.
- Guest Column: Parallel, Not Sequential, Activities are Pivotal to Reducing Clinical Trial Cycle Times (23 augustus 2021). WCG CenterWatch.
- Experts Outline Best Route for Sites When Completing Study Startup Documents (23 augustus 2021). WCG CenterWatch.
- Sites Need Sponsors’ Help to Fill in Quality Metrics Gaps in Remote Monitoring (23 augustus 2021). WCG CenterWatch.
- COVID has set the stage for trials to go digital say researchers (16 augustus 2021). Clinical Insider.
- When Clinical Trials Go Digital, Ethics Is Needed (18 augustus 2021). Data Ethics.
Datascience, Gegevensbronnen, Kunstmatige intelligentie, Statistics
- Eerste stappen in Europese regulering van artificiële intelligentie: algoritmes en patiëntenrechten. TvGR 2021, p. 381-389
- Excel autocorrect errors still plague genetic research, raising concerns over scientific rigour (26 augustus 2021). The Conversation.
- VIG: één loket voor medische data (25 augustus 2021). Vereniging Innovatieve Geneesmiddelen.
- Kankeronderzoek gebaat bij personal health train (23 augustus 2021). ICT & Health.
- NHS data grab on hold as millions opt out (22 augustus 2021). The Guardian.
- Israeli data: How can efficacy vs. severe disease be strong when 60% of hospitalized are vaccinated? (20 augustus 2021). Covid-19 Data Science.
- Start gezamenlijk, grootschalig Long-COVID-onderzoek waarin diverse methodes en gegevensbronnen worden gecombineerd (30 juli 2021). NIVEL.
European Medicines Agency (EMA)
- Workplan 2021-2023 – HMA / EMA joint Big Data Steering Group (27 augustus 2021).
- EMA goes all in on big data (27 augustus 2021). Regulatory Focus.
EU Verordening betreffende klinische proeven met geneesmiddelen (ECTR), GCP, GMP
US Food and Drug Administration (FDA), Institutional Review Board (IRB)
- FDA issues 39 new and revised product-specific guidances (25 augustus 2021). Regulatory Focus.
- FDA: No plans yet to resume onsite GMP foreign inspections (25 augustus 2021). Regulatory Focus.
- Beginner’s Guide to Minimal Risk Research (23 augustus 2021). Advarra.
- FDA Notice Threatens Second Sponsor with Heavy Fines for Failure to Report Results (23 augustus 2021). WCG CenterWatch.
Overige
- Can preclinical drug development help to predict adverse events in clinical trials? (29 augustus 2021). Drug Discovery Today.
- Biotech’s data supporting Alzheimer’s trials under scrutiny (26 augustus 2021). Retraction Watch.
- A science in the shadows. Controls on ‘gain of function’ experiments with supercharged pathogens have been undercut despite concerns about lab leaks (26 augustus 2021). The Washington Post.
- Too many scientists still say Caucasian (24 augustus 2021). Nature.
- What should you do when you get a result that seems wrong, but you can’t find any problems in the underlying data or calculations? (23 augustus 2021). Dynamic Ecology.
- Penn Medicine apologizes for notorious doctor who conducted experiments on Holmesburg Prison inmates (21 augustus 2021). The Philadelphia Inquirer.
Meer actueel nieuws, bijeenkomsten en publieke consultaties
Hi Vincent,
https://www.sciencedirect.com/science/article/abs/pii/S1359644621003706?via%3Dihub
Seems like an interesting publication: Have you read it, and, in case so, what is your main take away?
Thanks!
Annet
Hi Annet,
Not groundbreaking but nice to read and insightfull short overview of certain developments in preclinical drug development and toxicity testing methods. Plea for further development and research, and the deployment of these methods on a case-by-case basis (evt. in combination with other methods: AI).
Vincent