Uitgelicht en gespot op internet (week 9, 2023)
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.
Er is ook weer een nieuwe publieke consultatie toegevoegd aan het overzicht op de ‘Consultations‘ pagina.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn en Mastodon.
Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG), WGBO
- Guidelines 05/2021 on the Interplay between the application of Article 3 and the provisions on international transfers as per Chapter V of the GDPR (24-02-2023). EDPB.
- Heeft mijn patiënt recht op vernietiging van zijn medisch dossier? (19-01-2023). KNMG.
Clinical trials, Clinical research
- FDA rejects Covid-19 drug over uncertainties around small trial (03-03-2023). Endpoints News.
- Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy? (02-03-2023). BMJ.
- The Limited Impact of COVID-19 on US Clinical Trial Activity (28-02-2023). Applied Clinical Trials.
- ICH to adopt final guideline on drug interaction studies early next year (27-02-2023). Regulatory Focus.
- Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials (24-02-2023). Advarra.
Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)
Clinical Trials Coordination and Advisory Group (CTAG)
Expert group on clinical trials (CTEG)
EU Geneesmiddelenwetgeving |
Diversity, Inclusion, Retention, Representative
- The Impact of Trial Design on Interest by Race and Ethnicity (03-03-2023). Applied Clinical Trials.
- Tackling Trial Diversity Through Higher Innovation Standards (03-03-2023). Applied Clinical Trials.
- Rebooting the Statistic That 5% of Eligible Patients Participate in Clinical Trials (02-03-2023). Applied Clinical Trials.
- Considerations to Reach Underrepresented Groups (28-02-2023). Applied Clinical Trials.
- How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and Retention (28-02-2023). Applied Clinical Trials.
- Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials. Trials 24, 127 (2023).
Drug Information Association
- DIA Global Forum (March 2023).
- Protecting Clinical Research, Researchers, and Research Participants in Ukraine.
- From COVID-19 Pandemic to War: Clinical Trial Industry Powers On Under Extreme Conditions.
- Cancer Trial Continuity in Ukraine Is a Shared Responsibility and a Global Imperative.
Dutch Oncology Research Platform (DORP)
European CRO Federation (EUCROF)
European Data Protection Board (EDPB)
- EDPB welcomes improvements under the EU-U.S. Data Privacy Framework, but concerns remain (28-02-2023).
- Opinion 5/2023 on the European Commission Draft Implementing Decision on the adequate protection of personal data under the EU-US Data Privacy Framework (28-02-2023).
- EDPB publishes a procedure for the adoption of EDPB Opinions on national criteria for certification and European Data Protection Seals (27-02-2023).
Kunstmatige Intelligentie (KI)
- Eyeing a Role for Artificial Intelligence in Clinical Trials. JAMA Ophthalmol. Published online February 23, 2023. doi:10.1001/jamaophthalmol.2022.6542.
- AI and Neurotechnology: Learning from AI Ethics to Address an Expanded Ethics Landscape (22-02-2023). Communications of the ACM.
- Garbage in, Garbage out—Words of Caution on Big Data and Machine Learning in Medical Practice. JAMA Health Forum. 2023;4(2):e230397. doi:10.1001/jamahealthforum.2023.0397.
Medicines and Healthcare prodsucts Regulatory Agency (MHRA)
Stem cells, Organoids, Embryo
- Stem cell research ethics topics: organoid consciousness & embryo models (28-02-2023). The Niche.
- Citizens’ jury votes in favour of editing human embryos to treat serious genetic conditions (23-02-2023). Wellcome Connecting Science.
- Organoid intelligence (OI): the new frontier in biocomputing and intelligence-in-a-dish. Front Sci (2023) 1:1017235. doi: 10.3389/fsci.2023.1017235
Weesgeneesmiddelen
- Strategies for Building Greater DE&I in Rare Disease Trials (02-03-2023). Applied Clinical Trials.
- My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility (28-02-2023). STAT.
- Q&A: Ethics of ultra-rare disease drug development and expanded access (28-02-2023). Clinical Trials Arena.
Overig
- Research misconduct and questionable research practices form a continuum (03-03-2023). Accountability in Research.
- What the Cochrane “masks don’t work” review does (and does not) tell us (03-03-2023). Reflections on Infection Prevention and Control.
- Betaalt de samenleving nog steeds twee keer voor nieuwe geneesmiddelen? (22-02-2023). Medisch Contact.
- Here’s why we’re not prepared for the next wave of biotech innovation (03-11-2022). STAT.
- How your brain data could be used against you (24-02-2023). MT Technology Review.
- COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise. IEEE Open Journal of Engineering in Medicine and Biology, vol. 3, pp. 167-170, 2022, doi: 10.1109/OJEMB.2022.3217431.
- Wat kan Nederland leren van Vlaams life sciences centrum om talent te boosten? (28-02-2023). HollandBio.
- New dose optimization guidance released for cancer drugs (09-02-2023). Nature Reviews Drug Discovery.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties