Uitgelicht en gespot op internet (week 23, 2021)
Hierbij ontvangt u weer een nieuw overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet.
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AVG, Bescherming persoonsgegevens, Brexit, Standard Contractual Clauses (SCC)
- Case Law Digest 2021: Transfers of personal data to third countries (10 juni 2021). EDPS.
- Casuïstiek van overleden patiënten. Kan die zomaar worden gepubliceerd? (8 juni 2021). NTvG.
- The updated standard contractual clauses — A new hope? (7 juni 2021). IAPP.
Amsterdam UMC
“With the intention of setting a standard, structuring information and making information accessible for all researchers, the Research Lifecycle is used to navigate the researcher through the Handbook. The Research Lifecycle represents all activities typically involved in a research project, and may be scientific or administrative in nature, or both. They begin with forming a hypothesis and conclude with final reports, scientific publications and the further utilization of knowledge.”
– bron: About, APH Quality Handbook
Biobanken, Wet zeggenschap lichaamsmateriaal (WZL)
Embryo onderzoek, Human gene editing
- Human Embryo Research Beyond 14 Days? International Perspectives (7 juni 2021). The Hastings Center.
- Setting ethical limits on human gene editing after the fall of the somatic/germline barrier (1 juni 2021). PNAS.
Clinical trials, Clinical trial registries
- The future of pandemic preparedness: agile coordination around clinical trials (10 juni 2021). STAT.
- The many uses of data in public clinical trial
registries (10 juni 2021). Current Science. - Selective Use of Decentralization Methods Best Bet for Most Trials Postpandemic (7 juni 2021). WCG CenterWatch.
Drug development
- COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis (11 juni 2021). EMA.
- EMA: Verder onderzoek naar ontsteking van de hartspier na coronavaccinatie (11 juni 2021). CBG.
- Vaxzevria: EMA advises against use in people with history of capillary leak syndrome (11 juni 2021). EMA.
- UK medicine regulator looking at capillary leak syndrome precaution for AstraZeneca shot (11 juni 2021). Reuters.
- FDA approved a new Alzheimer’s drug despite controversy over whether it works (7 juni 2021). Science.
- Elation, pride, and a slew of questions: Clinical trial participants reflect on their own complicated reactions to Aduhelm approval (8 juni 2021). STAT.
- Pfizer’s Speed in Developing COVID-19 Vaccine Can Be Replicated, Experts Say (7 juni 2021). WCG CenterWatch.
- Cognitive Go/No-Go decision-making criteria in Alzheimer’s disease drug development (mei 2021). Drug Discovery Today.
- Applications of artificial intelligence in drug development using real-world data (mei 2021). Drug Discovery Today.
Dutch Clinical Research Foundation (DCRF)
European Medicines Agency (EMA)
- Advancing international collaboration on COVID-19 real-world evidence and observational studies (4 juni 2021).
- SWP recommendations on the duration of contraception following the end of treatment with a genotoxic drug (27 februari 2021).
Global Alliance for Genomics and Health (GA4GH)
International Coalition of Medicines Regulatory Authorities (ICMRA)
- Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility (11 juni 2021).
- Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
Medical Device Coordination Group (MDCG)
Noncompliance
- Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data (8 juni 2021). US Department of Justice.
- FDA Has Long Way to Go to Correct Trial Reporting Noncompliance, Study Shows (7 juni 2021). WCG CenterWatch.
Patient Focused Medicines Development (PFMD)
U.S. Food and Drug Administration (FDA)
- Core Patient-Reported Outcomes in Cancer Clinical Trials. Draft Guidance for Industry (juni 2021).
- FDA releases draft guidance on assessment of PROs for cancer trials (9 juni 2021). Regulatory Focus.
Overige
- Meet a sleuth whose work has led to the identification of hundreds of fraudulent papers (10 juni 2021). Retraction Watch.
- Human challenge trials – how should the public be involved in pandemic research policy-making? (8 juni 2021). Nuffield Council on Bioethics.
- Cultural Values and Beliefs of Selected Local Communities in Botswana: Implications for Human Subject Research Ethics Practice (7 juni 2021). J Empir Res Hum Res Ethics.
- A ‘landmark’ trial to test mRNA vaccines against COVID-19 in Africa can’t get the coveted shots (7 juni 2021). Science.
- How COVID broke the evidence pipeline (12 mei 2021). Nature.
- Oncology Trial Starts Soar in 2020, Despite Pandemic Disruptions (7 juni 2021). WCG CenterWatch.
Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.
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