Uitgelicht en gespot op internet (week 45, 46, 47 & 48, 2021)
Wegens andere verplichtingen ben ik de afgelopen weken er niet aan toegekomen om de binnengekomen nieuwsberichten te screenen en op mijn blog te plaatsen.
Sinds gisteren heb ik weer wat tijd gevonden om de meer dan 400 berichten die de afgelopen weken zijn binnengekomen te filteren en een nieuw overzicht samen te stellen. Een deel van de nieuwsberichten zal waarschijnlijk al tot u zijn gekomen via andere kanalen. Voor de volledigheid en in het licht van de continuïteit van het supplement ‘Uitgelicht en gespot op internet‘ kon ik de binnengekomen nieuwsberichten niet zomaar weggooien. Daarbij, redelijke kans dat er nog interessante nieuwberichten zijn die u nog niet heeft gezien.
Heeft u nog ruimte over in uw agenda? Ook de ‘Events‘ pagina is weer voorzien van nieuwe events.
BBMRI-ERIC
- New European initiative will build a collaborative platform for data and sample sharing, to accelerate the discovery and validation of biomarkers for neurodegenerative diseases (3-11-2021).
- Code of conduct for health research – Presentation on Code of Conduct, V02.11.2021.
Biobanken, Organoids
- 200,000 whole genomes made available for biomedical studies by U.K. effort (18-11-2021). Science.
- Creation and use of organoids in biomedical research and healthcare: the bioethical and metabioethical issues (28-10-2021). Cell Adhesion & Migration.
Cambridge Network
Centrale Commissie Dierproeven (CCD)
Centrale Commissie Mensgebonden Onderzoek (CCMO)
- CCMO gesloten tussen Kerst en Oud en Nieuw (1-12-2021).
- Informatie Clinical Trial Regulation beschikbaar op CCMO-website (15-11-2021).
- Themagedeelte voor geneesmiddelenonderzoek volgens de CTR.
- Nieuwe model documenten
- Format jaarverslag METC (1-12-2021).
- P1b. Model nader besluit toevoeging centrum MDR-onderzoek artikel 74.1 positief (08-11-2021)
- P1b. Model nader besluit toevoeging centrum MDR-onderzoek artikel 82 positief (08-11-2021)
- P1b. Model nader besluit toevoeging centrum MDR-onderzoek artikelen 62.1 en 74.2 positief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikel 74.1 negatief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikel 74.1 positief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikel 82 negatief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikel 82 positief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikelen 62.1 en 74.2 negatief (08-11-2021)
- P2. Model nader besluit MDR-onderzoek artikelen 62.1 en 74.2 positief (08-11-2021)
Clinical trial results reporting
- FDA Should Get Far More Aggressive About Clinical Trial Reporting, Study Says (22-11-2021). WCG CenterWatch.
- FDA could do more to enforce ClinicalTrials.gov reporting requirements (15-11-2021). Regulatory Focus.
- Ask the Experts: ClinicalTrials.gov Compliance (15-11-2021). WCG CenterWatch.
- Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements (12-11-2021). JAMA.
Clinical trials, Pragmatic clinical trials
- eConsent: Sites and Sponsors Tout Benefits, Confront Obstacles (22-11-2021). WCG CenterWatch.
- Onsite Inspections Back to Normal, But Some Things Remain Changed (22-11-2021). WCG CenterWatch.
- COVID hit cell and gene therapy trials and suppliers but experts see signs of recovery (17-11-2021). Clinical Insider.
- Critical Challenges Persist for Sites in Staffing, Enrollment and Protocol Complexity (15-11-2021). WCG CenterWatch.
- Dedicated Sites, Private Practices Outdoing AMCs on Diversity Front (15-11-2021). WCG CenterWatch.
- Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory (13-11-2021). Military Medicine.
- Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations (12-11-2021). Clinical Trials.
- Site staff diversity vital for trial participant diversity according to Tufts (8-11-2021). Clinical Insider.
- A PI Compensation Case Study: Stamford Health (8-11-2021). WCG CenterWatch.
- Centralized Innovation Teams More Successful Than Decentralized Units, Survey Findings Reveal (8-11-2021). WCG CenterWatch.
- New Technology Is Biggest Hurdle for Sites Running Decentralized Trials (8-11-2021). WCG CenterWatch.
- Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop (2021). National Academies of Sciences, Engineering, and Medicine.
- FDA Trails Behind EMA, Health Canada on Proactive Data Transparency (8-11-2021). WCG CenterWatch.
- Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems (19-10-2021).
Clinical Trials Regulation (CTR), Clinical Trial Information System (CTIS).
- Informatie Clinical Trial Regulation beschikbaar op CCMO-website (15-11-2021). CCMO.
- Clinical Trial Information System (CTIS) – Sponsor handbook (updated) (2-12-2021). EMA.
- EMA: Clinical Trials Information System (CTIS): online modular training programme (updated)
- Instructor’s guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – CTIS Training Programme – Module 01 (updated) (15-11-2021).
- FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – CTIS Training Programme – Module 01 (updated).
- Step-by-step guide : Support with workload management in the sponsor workspace – CTIS Training Programme – Module 04.
- Step-by-step guide : Support with workload management in the authority workspace – CTIS Training Programme – Module 04.
- FAQs: Support with workload management by workspace – CTIS Training Programme – Module 04 (updated).
- EMA: EudraVigilance training and support
- EU CTR en VGO: welke impact hebben ze op onderzoek in Nederland? Beschouwingen vanuit het veld: Thera Max-Mos, Sanofi (23-11-2021). DCRF.
- EUCROF Podcast #4 – “EU CTR and CTIS. Ready or not… here it comes!” (19-11-2021). EUCROF.
- ACRON/DCRF symposium over CTR 11 november jl.- presentaties en video-opname nu online (18-11-2021). ACRON.
- ACRON/DCRF symposium over CTR 11 november jl.- presentaties en video-opname nu online (18-11-2021). DCRF.
- Informatie Clinical Trial Regulation beschikbaar op CCMO-website (15-11-2021). DCRF.
College ter Beoordeling van Geneesmiddelen (CBG)
Dierexperimenteel onderzoek
- Newsletter no. 6-2021 from Norecopa.
- Lancering Transparantieovereenkomst Dierproeven (2-11-2021). Stichting Dierproeven.
Drug development
- FDA shares research to improve dose selection in pediatric drug development (23-11-2021). Regulatory Focus.
- Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity (10-11-2021). Regulatory Focus.
- White paper bolsters ctDNA as potential ‘early endpoint’ in cancer approvals (9-11-2021). Regulatory Focus.
- Making a medicine”. Check out Step 1:Pre-discover. EUPATI.
Dutch Association of Research Quality Assurance (DARQA)
Dutch Clinical Research Foundation (DCRF)
Dutch Oncology Research Platform (DORP)
- Wat biedt DORP… (1-12-2021).
- Shaping the future of DORP – denk met ons mee! (16-11-2021) [13-12-2021].
European Clinical Research Infrastructure Network (ECRIN)
European Federation of Academies of Sciences and Humanities (ALLEA), Federation of European Academies of Medicine (FEAM)
European Medicines Agency (EMA)
- ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic (3-12-2021).
- Clinical Trial Information System (CTIS) – Sponsor handbook (updated) (2-12-2021).
- Guide on advanced therapy medicinal products – Clinical development flowchart (29-11-2021).
- Guide on advanced therapy medicinal products – Non-clinical development flowchart (29-11-2021).
- Guide on advanced therapy medicinal products – Quality flowchart (29-11-2021).
- A vision for use of real-world evidence in EU medicines regulation (24-11-2021).
- Clinical Trials Information System (CTIS): online modular training programme (updated)
- Instructor’s guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – CTIS Training Programme – Module 01 (updated) (15-11-2021).
- FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 – CTIS Training Programme – Module 01 (updated).
- Step-by-step guide : Support with workload management in the sponsor workspace – CTIS Training Programme – Module 04.
- Step-by-step guide : Support with workload management in the authority workspace – CTIS Training Programme – Module 04.
- FAQs: Support with workload management by workspace – CTIS Training Programme – Module 04 (updated).
- EudraVigilance training and support
European Research Council (ERC)
EQUATOR Network
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)
Global Alliance for Genomics and Health (GA4GH)
- In this issue: GA4GH standards enable the responsible sharing of human genomic and biomedical data (10-11-2021). Cell Genomics.
- I can drive in Iceland: Enabling international joint analyses (10-11-2021). Cell Genomics.
- GA4GH: International policies and standards for data sharing across genomic research and healthcare (10-11-2021). Cell Genomics.
- Partnerships to enable the responsible sharing of biomedical data (10-11-2021). Cell Genomics.
- The Data Use Ontology to streamline responsible access to human biomedical datasets (10-11-2021). Cell Genomics.
- International federation of genomic medicine databases using GA4GH standards (10-11-2021). Cell Genomics.
Health-RI
- 1st release: Implementation-standard Personal Health Train (29-11-2021).
- HEART4DATA: consortium to develop and test a sustainable infrastructure for cardiovascular registration-based research in the Netherlands (23-11-2021).
Information Commissioner’s Office (ICO) (Verenigd Koninkrijk)
Innovative Medicines Initiative (IMI)
Medicines and Healthcare products Regulatory Agency (MHRA)
- Clinical trials for medicines: authorisation assessment performance (updated 16-11-2021).
- Managing clinical trials during Coronavirus (COVID-19) (updated 16-11-2021).
Medische hulpmiddelen, Good Machine Learning Practice (GMLP), In Vitro Diagnostic Regulation (IVDR), Eudamed
- IVDR amendment proposal update: moving on up to adoption (1-12-2021). Medicaldeviceslegal.
- Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed).
- Time to simplify ISO 13485 (21-11-2021). Michael Schaefer, via LinkedIn.
- Ten International Guiding Principles on Good Machine Learning in Medical Devices. BioSlice Blog, Arnold & Porter (11-11-2021).
- Ballerine: toepassing had veiliger gekund, CE nog geschorst (10-11-2021). IGJ.
- Regulators release 10 principles for good machine learning practice (27-10-2021). Regulatory Focus.
Monitoring, Gegevensbescherming (Frankrijk)
Nationaal Comité advies dierproevenbeleid (NCad)
Nederlands Trial Register
NHS Health Research Authority (Verenigd Koninkrijk)
- Combined review for all CTIMPs coming soon (26-11-2021).
- Working together to make public involvement better (26-11-2021).
- Research Ethics Committee members help develop new tool to benefit people who participate in research (15-11-2021).
- Clinical trials of the future – a blog by Dr Janet Messer, Director of Approvals (12-11-2021).
METC AVL, METC Utrecht
- Fusie METC’s AVL, Máxima en UMC Utrecht (26-10-2021). METC Utrecht.
- Fusie METC’s AVL, Prinses Máxima Centrum en UMC Utrecht (10-11-2021). Antoni van Leeuwenhoek.
Pedmed-NL – Dutch Paediatric Clinical Trial Network
Personal Health Train
Retraction watch
- Weekend reads: Nepotism in journals; the lessons of the ‘lab leak’ theory; four decades of research misconduct (27-11-2021). Retraction Watch.
- Weekend reads: An error in a PLOS journal leads to angry calls to Fauci; Jonathan Pruitt placed on leave; Cassava Sciences under SEC investigation (20-11-2021). Retraction Watch.
- Weekend reads, double edition: Scamming journals to publish gibberish; a whole issue with nothing but retractions; ‘the unbearable lightness of scientometric indices’ (13-11-2021). Retraction Watch.
SOPs4RI
Stichting CGR
TransCelerate BioPharma Inc.
- The Pulse on Progress: TransCelerate Shares Third Quarter Highlights (18-11-2021).
- Seven ways to diversify patient populations in clinical trials (3-8-2021).
US Food and Drug Administration (FDA)
- Draft guidance: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (29-11-2021).
- FDA offers draft guidance for registries as RWD (29-11-2021). Regulatory Focus.
- FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions (22-11-2021). FDA Law Blog.
Overige
- How much do the public sector and the private sector contribute to biopharmaceutical R&D? (1-12-2021). Drug Discovery Today.
- EU official says ICH Q6B is outdated and needs revision (1-12-2021). Regulatory Focus.
- Systematic risk identification and assessment using a new risk map in pharmaceutical R&D (december 2021). Drug Discovery Today.
- Persbericht Lancering rapport impact COVID-19-pandemie op wetenschappers (30-11-2021). De Jonge Akademie.
- Veel minder tijd voor wetenschappelijk onderzoek door covid-19 (30-11-2021). Skipr.
- Trust, trustworthiness and sharing patient data for research (29-11-2021). Journal of Medical Ethics.
- ICH recaps progress made over past year, charts new topics (29-11-2021). Regulatory Focus.
- Want research integrity? Stop the blame game (24-11-2021). Nature.
- Question the ‘lab leak’ theory. But don’t call it a conspiracy (23-11-2021). Knowable Magazine.
- Kamer wil publiek-privaat expertisecentrum medicijnontwikkeling (23-11-2021). Vereniging Innovatieve Geneesmiddelen.
- Professionele autonomie (23-11-2021). NTvG.
- Misidentified biomedical resources: Journal guidelines are not a quick fix (22-11-2021). International Journal of Cancer.
- Advocacy Group Pushes FDA to Disqualify Minneapolis IRB, Investigators from Running Trials (22-11-2021). WCG CenterWatch.
- Keeping science reproducible in a world of custom code and data (19-11-2021). ARS Technica.
- Procedures and Principles of Disposal of Research Misconduct in Japan From the Perspective of Case Analysis (16-11-2021). SAGE Open.
- The past, present and future of Registered Reports (15-11-2021). Nature Human Behaviour.
- Zoek het uit (9-11-2021). NTvG.
- Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response: Lessons from COVID-19 (2021). National Academies of Sciences, Engineering, and Medicine.
- Priorities On The Health Horizon: Informing PCORI’s Strategic Plan. A Special Publication from the National Academy of Medicine (2021).
- Brain safety concerns of nanomedicines: The need for a specific regulatory framework (november 2021). Drug Discovery Today.
- Implications of sex-related differences in central nervous system disorders for drug research and development (5-7-2021). Nature Drug Reviews Drug Discovery.
Meer actueel nieuws, bijeenkomsten en publieke consultaties