Uitgelicht en gespot op internet (week 35, 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.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
Algemene verordening gegevensbescherming (AVG), European Health Data Space (EHDS)
- Patiënten willen keuzemogelijkheden bij delen van hun medische gegevens voor zorgverbetering (01-09-2023). Patiëntenfederatie Nederland.
- De Nederlandse regels voor hergebruik van patiëntgegevens en lichaamsmateriaal voor onderzoek zijn beperkender en onduidelijker dan in veel andere Europese landen (25-08-2023). MLCF.
- Toetsingskader voor de doorgifte van persoonsgegevens (24-08-2023). SURF.
- The Estimand Framework had Implications in Time to Patient-Reported Outcomes Deterioration Analyses in Cancer Clinical Trials. J Clin Epidemiol. 2023 Aug 25:S0895-4356(23)00215-9.
- Factsheet – Personal data protection (01-07-2023). European Court of Human Rights.
- Webinar Privacy DTIA (28-06-2023). Centrum Informatiebeveiliging en Privacybescherming.
- The General Data Protection Regulation. Articles and Recitals integrated edition. 2040 Training Ltd.
| Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)
Duitsland, Bundesregierung
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Coalition for Epidemic Preparedness Innovations’ (CEPI
Coordinating Research and Evidence for Medical Devices (CORE-MD)
European Forum for Good Clinical Practice (EFGCP)
Fraud, Misconduct, Integrity
- Stelselmatige fraude met Europese subsidies voor onderzoek brengt academische ziekenhuizen in grote problemen (02-09-2023). FTM.
- Na LUMC lijkt ook UMC Utrecht slachtoffer subsidie-sjoemelaar (28-08-2023). Skipr.
- FDA Warns PI for Eligibility Criteria, Study Drug Administration Issues (28-08-2023). CenterWatch.
- ‘Gagged and blindsided’: how an allegation of research misconduct affected our lab (25-08-2023). Nature.
- When snowball sampling leads to an avalanche of fraudulent participants in qualitative research. Int J Older People Nurs. 2023 Aug 26:e12572. doi: 10.1111/opn.12572.
- Scammers threaten quality of research survey data (24-08-2023). Spectrum.
- Identifying and preventing fraudulent responses in online public health surveys: Lessons learned during the COVID-19 pandemic. PLOS Global Public Health 3(8): e0001452.
- Research integrity during the COVID-19 pandemic: Perspectives of health science researchers at an Academic Health Science Center. Account Res. 2023 Dec;30(7):471-492. doi: 10.1080/08989621.2022.2029704.
- The trinity of good research: Distinguishing between research integrity, ethics, and governance. Account Res. 2023 Jul 25:1-20. doi: 10.1080/08989621.2023.2239712.
- ENRIO Handbook on Whistleblower Protection in Research (31-07-2023). Zenodo.
Genetisch gemodificeerde organismen (GGO’s)
Good Clinical Practice (GCP)
Historie
- The Infamous Drug Trial That Shocked Britain | Real Stories Full-Length Medical Documentary (11-04-2018). Real Stories, via LinkedIn.
- Toezicht op het medisch-wetenschappelijk onderzoek met mensen: het in kaart brengen van een multi-centered speelveld (augustus 2015). iBMG.
Keuringsraad
Kunstmatige Intelligentie (KI)
- Large language models aren’t people. Let’s stop testing them as if they were (30-08-2023). MIT Technology Review.
- Defending explicability as a principle for the ethics of artificial intelligence in medicine. Med Health Care Philos. 2023 Aug 29. doi: 10.1007/s11019-023-10175-7.
Medical Dictionary for Regulatory Activities (MedDRA)
Medische hulpmiddelen, Medical Device Regulation (MDR)
- Can we fix / improve the MDR and the IVDR? (29-08-2023). Medicaldeviceslegal.
- Wetenschappelijk onderzoek en de MDR: wat kan en mag zonder CE-markering? (29-08-2023). ICTRecht.
- Stressmeters in smartwatches maken geen onderscheid tussen opwinding en stress (27-08-2023). Vrije Universiteit Amsterdam.
- The tricky ethics of brain implants and informed consent (25-08-2023). MIT Technology Review.
NHS Health Research Authority (HRA)
- New pilot to make it easier to set up research involving health and social care staff as participants (31-08-2023).
- Our response to concerns raised about the ‘Outcomes for children referred to the Gender Identity Development Service’ research study (15-08-2023).
- “Tell us what you think: guidance on how to involve patients and the public in the design and delivery of clinical trials. … The survey will close on 29 September 2023.“.
- “Information on the National Contract Value Review (NCVR) stage two, following the Lord O’Shaughnessy Review: read about its roll-out and scope“.
Nieuwsbrief voor Goede Onderzoekspraktijken
Nuffield Council on Bioethics
- The application of AI to genomics raises ‘urgent’ ethical questions, early findings suggest (31-08-2023).
- Towards a best practice UK model for ethical standards in genomics healthcare and research (27-07-2023).
Nederlandse Federatie van Universitair Medische Centra (NFU)
PROMISE Consortium (Preparing for RSV Immunisation and Surveillance in Europe)
Repurposing
- Repurposed drug studies on the primary prevention of SARS-CoV-2 infection during the pandemic: systematic review and meta-analysisBMJ Open Respiratory Research 2023;10:e001674. doi: 10.1136/bmjresp-2023-001674.
- The potential of innovative trial design for efficiently evaluating repurposed drugs (03-08-2023). Nature Reviews Drug Discovery.
US Food and Drug Administration’s (FDA)
- Final guidance: Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment : Guidance for Industry (05-09-2023).
- Final guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products. Guidance for Industry (30-08-2023).
- ClinicalTrials.gov – a Three-Part Series (09-08-2023). In a three-part webinar series, FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements. Participants will gain an understanding of CDER’s role and responsibilities with respect to ClinicalTrials.gov oversight and will hear examples of compliance and enforcement activities CDER has taken to encourage compliance.
- FDA finalizes guidance on real-world evidence in drug approvals (31-08-2023). Regulatory Focus.
- Stakeholders want FDA to consider latest advancements in diabetes drug efficacy draft guidance (29-08-2023). Regulatory Focus.
- Psychedelic drug trial guidance: Commenters see vital role for psychotherapy (29-08-2023). Regulatory Focus.
- Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product Development (29-08-2023). FDA Law Blog.
- FDA issues final guidance on obtaining informed consent in drug and device clinical trials (15-08-2023). Regulatory Focus.
- FDA updates off-the-shelf software guidance to reflect least burdensome approach (14-08-2023). Regulatory Focus.
- FDA draft guidance focuses on postapproval trial diversity data 14-08-2023). Regulatory Focus.
- More than half of novel drug approvals were based on single studies in 2022 (11-08-2023). Regulatory Focus.
- New Drugs Approved With Fewer Trials and Less Public Information, Study Suggests (25-08-2023). Technology Networks.
- Stakeholders seek risk-based approach from FDA on regulating AI/ML for drug development (10-08-2023). Regulatory Focus.
Voedingsmiddelen
Overig
- Weekend reads: A journey through a paper mill; Stanford president’s retractions; developments in Gino case (02-09-2023). Retraction Watch.
- The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022. Appl Health Econ Health Policy (2023).
- Standards for Human Stem Cell Use in Research. International Society for Stem Cell Research.
- Enhancing reproducibility in human stem cell research (30-08-2023). Nature.
- How to Make Clinical Trials for Elderly with Disabilities More Inclusive (28-08-2023). The Clinical Trial Vanguard.
- Enabling the Nonhypothesis-Driven Approach: On Data Minimalization, Bias, and the Integration of Data Science in Medical Research and Practice (30-08-2023). The American Journal of Bioethics
- The Ethics of Publishing Biomedical and Natural Products Research (28-08-2023). J. Nat. Prod.
- Research participants’ perspectives about the return of uninformative genomic test results in a clinical research setting. J Genet Couns. 2023 Aug 28. doi: 10.1002/jgc4.1772.
- The benefits of Open science are not inevitable: monitoring its development should be value-led (14-08-2023). LSE.
- Benefit-risk assessment of vaccines. Vaccine. 2023 Aug 8:S0264-410X(23)00872-1. doi: 10.1016/j.vaccine.2023.07.041.
- Applying Lessons Learned from COVID-19 Research and Development to Future Epidemics: Proceedings of a Workshop. Washington, DC: The National Academies Press.
- Let’s be more idealistic about pragmatism in clinical research (24-08-2023). BMC Series Blog.
- Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments. BMC Med Res Methodol 23, 148 (2023).
- New cell sources for CAR-based immunotherapy. Biomark Res. 2023 May 6;11(1):49. doi: 10.1186/s40364-023-00482-9.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties