Uitgelicht en gespot op internet (week 22, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Vergeet niet om ook de ‘Consultations‘-overzichtspagina (consultations.bontrop.com) en de ‘Events‘ overzichtspagina (events.bontrop.com) te bezoeken. Ook zijn er weer een aantal nieuwe boeken toegevoegd aan de Boekenplank!
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Artificial intelligence, Kunstmatige Intelligentie (KI), MDR/IVDR
- Artificial intelligence in healthcare. Applications, risks, and ethical and societal impacts (01-06-2022). European Parliamentary Research Service.
- Legal analysis – European legislative proposal draft AI act and MDR/IVDR (31-01-2022).
BBMRI-ERIC
Bureau Medicinale Cannabis (BMC)
- Medicinale cannabis slaat niet aan (31-05-2022). Skipr.
- Kamerbrief over beleidsinzet medicinale cannabis (30-05-2022). Ministerie van Volksgezondheid, Welzijn en Sport.
Cel-, gen- en weefseltherapieën, Genetically Modified Organism (GMO)
- Is België klaar voor cel-, gen- en weefseltherapieën? (31-05-2022). Pharma.be.
- One size doesn’t fit all? FDA may soften some cell therapy regs (27-05-2022). The Niche, Trusted stem cell blog & resources.
- FDA’s Peter Marks lays out plans to support gene therapies for ultra-rare diseases (01-06-2022). Endpoints News.
- 20 Years of Legislation – How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic (10-05-2022). Front. Med.
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trials, Clinical Trials Regulation (CTR), European Commission, European Medicines Agency (EMA), Heads of Medicines Agencies (HMA)
- Questions and answers – Complex clinical trials Version 2022-05-23.
- Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.1, May 2022
- Pitfalls to Avoid with Clinical Adjudication (03-06-2022). Applied Clinical Trials.
- Bioethicists weigh in: Xenotransplantation may be here ‘within the next five years,’ but concerns loom (03-06-2022). Endpoints News.
- The Future of Clinical Trials: Turning Data Chaos into Trial Intelligence (03-06-2022). Applied Clinical Trials.
- Just How ‘Real’ is Real-World Data? (03-06-2022). Applied Clinical Trials.
- Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (02-06-2022). Trials.
- Tolerating bad health research: the continuing scandal (02-06-2022). Trials.
- SurvivorNet unveils AI-powered tool for patients to find cancer trials (02-06-2022). Clinical Trials Arena.
- Tolerating bad health research: the continuing scandal (02-06-2022). Trials.
- Why We Need Stricter Oversight of Research Involving Human Subjects Affected by Conflict (juni 2022). AMA Journal of Ethics.
- Under Pressure: Are Enhanced Global Efforts Enough For Trial Transparency? (01-06-2022). In Vivo.
- Fewer dry AMD clinical trials than wet variety despite no treatment options (02-06-2022). Clinical Trials Arena.
- Early signs support revolutionary potential of EU clinical trials regulation (01-06-2022). Science X.
- Clinical Trials in Ukraine During the War (01-06-2022). Applied Clinical Trials.
- How Study Sites Experienced Clinical Trial Changes During Pandemic (01-06-2022). Applied Clinical Trials.
- Covid-19, clinical trials, and the new normal: data shows decentralisation is here to stay (01-06-2022). Clinical Trials Arena.
- UK shuts down all ‘unviable’ clinical trials (31-05-2022). TranspariMED.
- The evolving landscape of decentralised/virtual clinical trials (31-05-2022). Clinical Trials Arena.
- Just-in-time: on schedule to rescue the clinical trial supply chain? (31-05-2022). Clinical Trials Arena.
- Preregistration: Practical Considerations for Speech, Language, and Hearing Research (31-05-2022). PsyArXiv.
- Using observational study data as an external control group for a clinical trial: an empirical comparison of methods to account for longitudinal missing data (28-05-2022). BMC Medical Research Methodology.
- Transition to new European clinical trials info system starts slowly (27-05-2022). Endpoints News
- WHO member states pledge to tackle research waste (25-05-2022). TranspariMED.
- Preregistration of research provides greater transparency (25-05-2022). Universiteit Utrecht.
- Structured reporting of study protocols (20-05-2022). On Medicine, BMC Blog Network.
- Detection of data manipulation in bioequivalence trials (januari 2022). European Journal of Pharmaceutical Sciences.
Dierexperimenteel onderzoek
- Clinical Phenotypes of Heart Failure With Preserved Ejection Fraction to Select Preclinical Animal Models (25-05-2022). J Am Coll Cardiol Basic Trans Science.
- Replacement of animal testing by integrated approaches to testing and assessment (IATA): a call for in vivitrosi (03-05-2022). Archives of Toxicology.
Dutch Oncology Research Platform (DORP)
Early access
Embryowet, Wet zeggenschap lichaamsmateriaal
Zoals reeds aangekondigd in het regeerakkoord: gezamenlijke initiatiefwet VVD en D66 wijziging Embryowet
In het licht van de Wet zeggenschap lichaamsmateriaal (WZL):
European Commission, Clinical Trials Expert Group (CTEG)
European Data Governance
- Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (Text with EEA relevance).
- Brief regering: Fiche: Mededeling en verordening Europese ruimte voor gezondheidsgegevens (03-06-2022). minister van Buitenlandse Zaken.
European Patients’ Academy on Therapeutic Innovation (EUPATI)
Good Clinical Practice (GCP), Inspections
Inclusion and ethics in global research collaborations
- Nature addresses helicopter research and ethics dumping (30-05-2022). Nature.
- Introducing a new approach to address inclusion and ethics in global research (31-05-2022). Springer Nature Group.
International Council for Harmonisation (ICH)
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
In Vitro Diagnostics Regulation (IVDR)
Journals, Publications
- Continued Visibility of COVID-19 Article Removals (juni 2022). Southern Medical Journal.
- Want to know whether that journal is scamming you? Introducing the Retraction Watch Hijacked Journal Checker (29-05-2022). Retraction Watch.
- A randomized trial alerting authors, with or without co-authors or editors, that research they cited in systematic reviews and guidelines has been retracted (23-05-2022). Accountability in Research.
- An Ethical Exploration of Increased Average Number of Authors Per Publication (23-05-2022). Science and Engineering Ethics.
National eHealth Living Lab (NeLL)
Nieuwsbrief voor Goede Onderzoekspraktijken
Opinie
- Rosanne Hertzberger: Wetenschappers zijn notoir beïnvloedbaar (04-06-2022). NRC.
- Kustaw Bessems: Ik probeer me het juiste soort wantrouwen eigen te maken, te mikken op de sweet spot. Het valt niet mee (03-06-2022). De Volkskrant.
- Rosanne Hertzberger: Hoe durf ik het beter te weten dan Dijkgraaf? (28-05-2022). NRC.
Paul-Ehrlich-Institut (Duitsland)
Pharma.be
Prediction model
Proefschriften
Publieke consultatie
R
Rathenau Instituut
- Kennis voor het wetenschapsbeleid (01-06-2022).
- R&D-uitgaven naar uitvoerende sector, als % van het BBP (internationaal) (17-05-2022).
UK Research Integrity Office (UKRIO)
U.S. Food and Drug Administration (FDA), Verenigde Staten
- Final guidance: Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (06-06-2022).
- Final guidance: Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Clinical/Medical (27-05-2022).
Wet zeggenschap lichaamsmateriaal (WZL)
Overige berichten
- Weekend reads: Researcher has paper retracted, then earns promotion; is peer review ‘more cavalier, self-serving, and ignorant?’; a ‘weird notice’ for all a publisher’s papers (04-06-2022). Retraction Watch.
- Multiple deadlocks in the development of nonprofit drugs (03-06-2022). Drug Discovery Today.
- Funders: The missing link in equitable global health research? (03-06-2022). PLOS Glob Public Health.
- Elk onderzoek verdient meerdere statistische analyses (02-06-2022). Medisch Contact.
- Meta-Analyses in Psychology Often Overestimate Evidence for and Size of Effects (01-06-2022). PsyArXiv.
- Half of researchers admit questionable practices in Dutch survey (01-06-2022). University World News.
- Diverse medicijnen raken vergunning kwijt om rammelend onderzoek (31-05-2022). Medisch Contact.
- Drug repurposing: An effective strategy to accelerate contemporary drug discovery (31-05-2022). Drug Discovery Today.
- The Impact of Structured and Standardized Documentation on Documentation Quality; a Multicenter, Retrospective Study (27-05-2022). Journal of Medical Systems.
- A Paradox of Ethics: Why People in Good Organizations do Bad Things (27-05-2022). Journal of Business Ethics.
- Xenotransplantatie-experimenten zijn aanzet tot maatschappelijk debat (27-05-2022). Medisch Contact.
- Scientists Must Consider the Risk of Racist Misappropriation of Research (26-05-2022). Scientific American.
- Why “stealth research” is the bane of scientific inquiry (22-05-2022). Salon.
- How to be a Research Detective – screening studies for fake research. NSWHSB External seminar series 2022 (10-05-2022).
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties