Uitgelicht en gespot op internet (week 12, 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.
Centrale Commissie Dierproeven (CCD)
- Wijzigingsaanvragen door het nieuwe uitvoeringsbeleid voor Genetisch Gewijzigde Dieren (24-03-2023).
Centrale Commissie Mensgebonden Onderzoek (CCMO)
| Clinical Trial Regulation (CTR), Clinical Trials Information System (CTIS) |
Clinical trials
- Decentralized trials getting some attention on the international regulatory front (24-03-2023). Regulatory Focus.
- What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics. Trials 24, 203 (2023).
- Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries [version 1; peer review: awaiting peer review]. Wellcome Open Res 2023, 8:120.
- Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials. Human Gene Therapy.
- Innovative Tools for Patient-Centric Clinical Trial Design: Examples and Applications from Eli Lilly (24-03-2023). Applied Clinical Trials.
- Clinical Trials Moving From Site to Home—Lessons Learned from Digital Health Technologies (23-03-2023). Applied Clinical Trials.
- The Harraseeket Conference – Revisiting systems for ethics oversight of research with human participants (23-03-2023). Research Ethics.
- Filling the Gaps in European Clinical Trial Reporting (22-03-2023). Applied Clinical Trials.
- Using Clinical Trial Sites’ Input to Select the Right Capabilities when Decentralizing Clinical Trials (22-03-2023). Applied Clinical Trials.
- New dashboard puts spotlight on research waste at German medical universities (21-03-2023). TranspariMED.
- Health Equity In Clinical Trials (21-03-2023). Applied Clinical Trials.
- Detecting (even more) outcome reporting bias in clinical trials by digging deep(er) (21-03-2023). TranspariMED.
- 15 highly questionable practices in clinical trial publications (21-03-2023). TranspariMED.
- UK: Despite strong progress on clinical trial reporting, gaps remain (20-03-2023). TranspariMED.
- Clinical Trial Addresses the Lack of Diversity in Dermatology Research (19-03-2023). Managed Healthcare Executive.
- Researchers Scramble to Meet Clinical Trial Diversity Rules (01-03-2023). Pharmaceutical Outsourcing.
College ter Beoordeling van Geneesmiddelen (CBG)
Commissie Genetische Modificatie (COGEM)
- Trendanalyse biotechnologie 2023. Tijd voor een integrale visie (21-03-2023).
- Nederland was koploper in biotechnologie, maar wordt nu links en rechts ingehaald (21-03-2023). Trouw.
Data delen
- Waarom is data delen zo moeilijk? (10-03-2023). Zorgvisie.
- Farminform: ‘Waarom is data delen zo moeilijk?’ (21-03-2023). Vereniging Innovatieve Geneesmiddelen.
- Health Data Agency: een centraal contactpunt voor secundair gebruik van gezondheidsgegevens in België (10-03-2023). Pharma.be.
Dierexperimenteel onderzoek
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Medicines Agency (EMA)
- Acceptability of IU as abbreviation for International Units in the strength of human medicinal products (24-03-2023).
- Advancing regulatory science in the EU – mid-point report published (22-03-2023).
- EMA’s Regulatory Science Strategy to 2025. Mid-point achievements to end 2022.
International Council for Harmonisation (ICH)
- The ICH Q9(R1) Introductory Training Presentation is now available on the ICH website (20-03-2023).
- ICH adopts S12 guideline for gene therapies (20-03-2023). Regulatory Focus.
Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)
- MDR and IVDR amendment has entered into force now (20-03-2023). Medicaldeviceslegal.
- Extension to EU MDR transition periods finalised (20-03-2023). BioSlcie Blog, Arnold & Porter.
Medicines and Healthcare products Regulatory Agency
- MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years (21-03-2023).
- Consultation outcome Government response to consultation on legislative proposals for clinical trials (Updated 21 March 2023).
- Euro Roundup: MHRA advances major overhaul of UK clinical trial regulation after positive feedback (23-03-2023). Regulatory Focus.
- New UK law will require all clinical trials to rapidly report results (23-03-2023). TranspariMED.
Signalement Therapeutische Toepassingen van Psychedelica
- Minister Kuipers neemt Signalement Therapeutische Toepassingen van Psychedelica in ontvangst (06-03-2023). ZonMw.
- Signalement Therapeutische Toepassingen van Psychedelica (mrt 2023).
Universiteiten van Nederland
- Succesvol webinar standaard deal-termprincipes (21-03-2023).
- Overheid moet steviger inzetten op Europees onderwijs- en onderzoeksbeleid (17-03-2023).
US Food and Drug Administration’s (FDA)
- Draft guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (24-03-2023).
- FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval (24-03-2023).
- FDA spells out how cancer drug developers can use one trial for both accelerated and full approvals (24-03-2023). Endpoints News.
- Framework for the Use of Digital Health Technologies (DHT) in Drug and Biological Product Development.
- NCI official raises concerns about FDA’s cancer drug dose optimization guidance (21-03-2023). Regulatory Focus.
- FDA issues guidance on submission of pharmacogenomic data (21-03-2023). Regulatory Focus.
- FDA outlines plan for digital health technologies for clinical trials (24-03-2023). Regulatory Focus.
- New US guidelines for decentralized and adaptive trials on the way (21-03-2023). Clinical Insider.
Overig
- Weekend reads: A bizarre shark story ends in a retraction; one scientist’s decades-long fight; the math wars (25-03-2023). Retraction Watch.
- The surprising biomedical legacy of the Iraq War (24-03-2023). STAT.
- Een nieuw prognostisch voorspelmodel voor hartfalen. Is de huisarts hiermee geholpen? (23-03-2023). NTvG.
- DARWIN EU ‘ramping up quickly’ with more partners coming on board (23-03-2023). Regulatory Focus.
- Stakeholders offer input on educational materials for rare disease drug development (22-03-2023). Regulatory Focus.
- A practical checklist for return of results from genomic research in the European context. Eur J Hum Genet (2023).
- The need for a new keyword — “Trial registry-metaresearch” — to track certain uses of clinical trial registry records. Trials 24, 190 (2023).
- VIRT2UE: A European train-the-trainer programme for teaching research integrity (23-03-2023). Research Ethics.
- Managed access programmes: expanding clinical development plans for patients in need (22-03-2023). Clinical Trials Arena.
- Analysis: Expanded access compliance falters among US drug companies (22-03-2023). Clinical Trials Arena.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties