Hierbij weer een nieuw overzicht van nieuws en andere ontwikkelingen die de afgelopen weken zijn gespot op het internet.
BBMRI-ERIC
Bescherming persoonsgegevens
- Territorial Scope and Data Transfer Rules in the GDPR: Realising the EU’s Ambition of Borderless Data Protection (16 april 2021). University of Cambridge Faculty of Law Research Paper No. 20/2021.
- EDPB cautiously welcomes UK adequacy finding (16 april 2021). LexBlog.
- ‘Breng privacyregels in diverse zorgwetten op één lijn’ (15 april 2021). Medisch Contact.
- International Sharing of Personal Health Data for Research (15 april 2021). COREON.
Centrale Commissie Dierproeven (CDD)
Clinical research,
- FDA: Master protocols have value in COVID-19, and beyond (15 april 2021). Regulatory Focus.
- Study Finds Pandemic Mitigation Efforts Impacted Trial Completion Rates (12 april 2021). WCG CenterWatch.
- Thousands of lives put at risk by clinical trials system that is ‘not fit for purpose’ (31 maart 2021). The Guardian.
- Combining drugs and extending treatment — a PFS end point is not sufficient (23 mei 2017). Nature Reviews Clinical Review.
COVID-19
- EU Covid19 open calls for proposals on Research Infrastructures, vaccines & treatments Clinical Trials and cohorts are now open.
- Cohorts united against COVID-19 variants of concern
- Vaccines & therapeutic clinical trials to boost COVID-19 prevention and treatment
- Research infrastructure services for rapid research responses to COVID-19 and other infectious disease epidemics
- FAIR and open data sharing in support to European preparedness for COVID-19 and other infectious diseases
Drug development, Farmacovigilantie,
- ‘We did need to throw a lot of spaghetti against the Covid window’: a biotech analyst on pandemic drug development (16 april 2021). STAT.
- Next-generation Covid-19 vaccines are supposed to be better. Some experts worry they could be worse (16 april 2021). STAT.
- Cerebral venous thrombosis: a retrospective cohort study of 513,284 confirmed COVID- 19 cases and a comparison with 489,871 people receiving a COVID-19 mRNA vaccine (preprint). OSF, 15 Apr. 2021.
- The J&J Vaccine Pause Is Science Working Like It’s Supposed To (15 april 2021). SLATE.
- I’m a Virus Expert Who Got the J&J Vaccine. I’m Not Losing Sleep. (15 april 2021). The New York Times.
- COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues (14 april 2021). EMA.
- AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets (14 april 2021). EMA.
- Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine (13 april 2021). FDA.
- FDA, CDC recommend J&J vaccine pause while rare clots investigated (13 april 2021). Regulatory Focus.
- U.S. urges pause on use of Johnson & Johnson Covid-19 vaccine after rare blood clotting cases (13 april 2021). STAT.
- U.S. pauses J&J vaccine rollout after 6 people of 6.8 million get rare blood clots (13 april 2021). Science.
- Why would a Covid vaccine cause rare blood clots? Researchers have found clues (13 april 2021). STAT.
- Voorzitter Gezondheidsraad: ‘Het beste voor vertrouwen in vaccins, is volkomen transparant zijn’ (12 april 2021). De Volkskrant.
- Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination (16 april 2021). NEJM.
- Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination (9 april 2021). NEJM.
- Brief report ‘Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination’ (9 april 2021). NEJM.
- Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson (2 februari 2021). STAT.
Embryo onderzoek
- International team creates first chimeric human-monkey embryos (15 april 2021). STAT.
- First monkey–human embryos reignite debate over hybrid animals (15 april 2021). Nature.
Ethics
European Union Drug Regulating Authorities Clinical Trials Database (EudraCT)
European Clinical Research Infrastructure Network (ECRIN)
- Marketplace for scientific clinical research on Covid-19 (12 april 2021).
- ECRIN Newsletter – April 2021 (14 april 2021).
Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)
Fieldlab studies
- Kabinet geeft Fieldlab Evenementen toestemming voor opschalen (13 april 2021). Ministerie EZK en OCW.
- Kabinet start pilots toegangstesten (6 april 2021). Ministerie VWS.
- Onderzoeken over gedrag en het coronavirus. Rijksoverheid.
Geneesmiddelenonderzoek, ECTR, CTIS
- Clinical Trials Information System (CTIS): training programme
- Industry Webinar – Introduction to RMS services and activities (15 maart 2021). EMA via YouTube.
- Industry Webinar Introduction to OMS services and activities (15 maart 2021). EMA via YouTube.
Gentherapie
Medische hulpmiddelen, MDR, IVDR
- MDR/IVDR: Commission adopts new standardization request (16 april 2021). Regulatory Focus.
- Verslag NVFG bijeenkomst “Medical Device trials: waar moet ik beginnen?” dinsdag 13 april 2021, door Joost Melis. NVFG.
- Download presentaties NVFG Medical Device Meeting (13 april 2021):
- Gert Bos – MDR en IVDR – “De essentials”
- Annet Muetstege – ISO 14155: 2020, de nieuwe GCP voor medical devices: Waar moet ik op letten?”
- Niels van Tienen – Medical data collection Platforms
- Erik Vollebregt – Artikel 117 MDR en Klinisch onderzoek met combinatie-producten en veranderingen in de juridische parameters
- Download presentaties NVFG Medical Device Meeting (13 april 2021):
- MDR date of application next month – and the book (11 april 2021). Medical devices legal.
Patient involvement
- Device Consortium Pushes for Stronger Patient Voice in Trials (12 april 2021).
- Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials (5 april 2021). Medical Device Innovation Consortium (MDIC).
Platform for European Preparedness Against (Re-)emerging Epidemics
Publications, Preprints
Safety reporting
ZonMw
Overige
- Journal of Clinical Research Best Practices, April 2021.
- Countries ‘must do their part’ in widening EU’s R&D strength (15 april 2021). Research Professional News.
- Why researchers created a database of half a million journal editors (13 april 2021). Nature Index.
- Views on ethical issues in research labs: A university-wide survey (13 april 2021). Accountability in Research.
- A self-correcting fallacy – Why don’t researchers correct their own errors in the scientific record? (13 april 2021). LSE Blog.
- Regulators: Focus Global Harmonization Efforts on Rare Disease Trials (12 april 2021). WCG CenterWatch.
- How to Handle Co-authorship When Not Everyone’s Research Contributions Make It into the Paper (12 april 2021). Science and Engineering Ethics.
- The informed consent process in health research with under-served populations: a realist review protocol (9 april 2021). Systemic Reviews.
- AI uses patient data to optimize selection of eligibility criteria for clinical trials (7 april 2021). Nature.
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