Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Vergeet niet om ook een bezoekje te plegen aan de Consultations-pagina (consultations.bontrop.com) en de Events-pagina (events.bontrop.com). Er zijn namelijk weer een aantal nieuwe publieke consultaties en evenementen toegevoegd aan de overzichten.
Veel leesplezier,
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn en Mastodon.
Adverse event risks
Algemene verordening gegevensbescherming (AVG)
- Brief regering: Facebook Pages DPIA en HRIA (18-11-2022). Ministerie van Binnenlandse Zaken en Koninkrijksrelaties.
- The GDPR International Data Transfer Regime: the case for Proportionality and a Risk-Based Approach (15-11-2022). DLA Piper.
Cancer research
- Research with integrity – the importance of communication (14-11-2022). Cancer Research UK.
- New pilot programme to boost quality and integrity in cancer research (17-11-2022). TranspariMED
Clinical trials
- Ted Trafford clinical trial acronyms (04-11-2022). Via YouTube (no-cookie link).
- Oncology phase I trial design and conduct: time for a change – MDICT Guidelines 2022, Annals of Oncology.
- The Changing Paradigm of Dose Selection in Oncology Drug Development (18-11-2022). Applied Clinical Trials.
- Running low on comparators: navigating drug shortages in oncology clinical trials (17-11-2022). Clinical Trials Arena.
- The Importance of IRT in the Decentralized Clinical Trial Landscape (16-11-2022). Applied Clinical Trials.
- Optimized Clinical Trials: A “From the Field” Webinar (16-11-2022). Applied Clinical Trials.
- Social Determinants Of Health Data Help Identify Sites For Trials (15-11-2022). Clinical Research News.
- Consent Management: Moving Beyond Simple eConsent (14-11-2022). Applied Clinical Trials.
- Regenerative medicine clinical trials continue to rise (14-11-2022). Clinical Trials Arena.
- Indian Sites Share Challenges as Clinical Trials Grow (14-11-2022). Applied Clinical Trials.
- FDA oversight of clinical trials is “grossly inadequate,” say experts BMJ 2022; 379 :o2628 doi:10.1136/bmj.o2628.
- Decentralized Trial Approaches: How Do They MatchUp To Conventional Studies? (11-11-2022). Trials@Home.
- Fit for the future: empowering clinical trials with digital technology (12-11-2022). European Heart Journal.
Clinical Trials Coordination and Advisory Group (CTAG)
Clinical trials regulation (CTR)
- Commission Delegated Regulation 2022/2239 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use (15-11-2022). Publicatieblad van de Europese Unie.
- Nieuwsbrief CCMO ‘CTR-themanummer’: Structuur onderzoeksdossier CTIS | RSI | Etikettering | Q&A (17-11-2022). CCMO.
College ter Beoordeling van Geneesmiddelen (CBG)
Data sharing
- Vivli To Expand Due To New Data-Sharing Policy Affecting NIH-Funded Research (16-11-2022). Clinical Research News.
- Despite progress in data transparency, the FDA still keeps its data secret (15-11-2022). TranspariMED
- Ethics challenges in sharing data from pragmatic clinical trials (07-09-2022). Clinical Trials.
Dierexperimenteel onderzoek
- Alternative Thinking about Animals in Research. NAM Perspectives. Commentary, National Academy of Medicine, Washington, DC.
- A qualitative study of the barriers to using blinding in in vivo experiments and suggestions for improvement. PLOS Biology 20(11): e3001873.
Ethics
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)
EudraCT: “Users have reported issues with uploading CTA XML files on EudraCT. Our IT is currently working on this, we thank you very much for your understanding and patience. ”
Update 16Nov2022: This issue is caused by a SPOR malfunction and is now intermittently ongoing, impacting EudraCT and CTIS.
Source: https://eudract.ema.europa.eu/
European Data Protection Board (EDPB)
- Publieke consultatie: Recommendations 1/2022 on the Application for Approval and on the elements and principles to be found in Controller Binding Corporate Rules (Art. 47 GDPR) (17-11-2022). Einddatum consultatie 10-01-2023.
European Health Data Space (EHDS)
European Medicines Agency (EMA), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Good Manufacturing Practice (GMP)
- Publieke consultatie: Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems (16-11-2022). Deadline for comments 16-01-2023.
- ACT EU state of play: EMA’s headway to transform clinical trials (15-11-2022). Clinical Trials Arena.
- Contribution of Real-World Evidence in European Medicines Agency’s Regulatory Decision Making (17-10-2022).Clinical Pharmacology & Therapeutics.
Foods for special medical purposes/medical foods, Levensmiddel, Geneesmiddel
- Foods for special medical purposes/medical foods: A global regulatory synopsis (17-11-2022). Regulatory Focus.
- Levensmiddel of geneesmiddel? Nieuwe ontwikkeling in de jurisprudentie. VMT. Helaas achter een betaalmuur.
Health-RI
Information Commissioner’s Office (ICO) (Verenigd Koninkrijk)
Medical Device Coordination Group (MDCG)
- MDCG 2020-10/1 Rev.1 Guidance on safety reporting in clinical investigations (October 2022).
- MDCG 2020-10/2 Rev. 1 Appendix: Clinical investigation summary safety report form (October 2022).
Medical devices, Software
- Patients’ role in development of Medical Devices (16-11-2022). EUPATI
- Who is the stricter regulatory parent? Clinical decision support software in the EU and the US (15-11-2022). Aidence.
Médecins Sans Frontières (MSF)
METC geeft groen licht voor onderzoek met nepoperatie
- Ziekenhuis MST krijgt groen licht voor 35 nepoperaties (en die zijn heel bijzonder) (16-11-2022). Tubantia.
- Toestemming voor 35 nepoperaties MST (17-11-2022). Skipr.
- Uit CCMO register: Coeliac Artery Release or Sham Operation (CARoSO) (NL81443.100.22)
Nature, Figshare, Open science
Nieuwsbrief voor Goede Onderzoekspraktijken
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 157 (18-11-2022).
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 156 (15-11-2022).
Research Ethics
TransCelerate Biopharma Inc.
UK Research Integrity Office (UKRIO)
- Annual statement on research integrity template (november 2022).
- The Concordat to Support Research Integrity (15-11-2022). Universities UK.
Universiteit Utrecht, Division of Pharmacoepidemiology and Clinical Pharmacology
US Food and Drug Administration (FDA), Verenigde Staten
- Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial (18-11-2022).
- FDA official discusses benefits, challenges of remote inspections (18-11-2022). Regulatory Focus.
- Stakeholders ask FDA to harmonize adverse events terms with standards orgs (17-11-2022). Regulatory Focus.
- Section 8200: Investigational New Drugs (INDs) (17-11-2022). FDA.
- Drug preclusion and public health: The case for a narrow interpretation of ‘article.’ Regulatory Focus. 17 November 2022. Regulatory Focus.
- Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials (17-11-2022). Advarra.
- FDA leaders Califf and Pazdur dish on accelerated approval reforms, single-country trials and an empty White Oak (17-11-2022). Endpoints News.
Vereniging Innovatieve Geneesmiddelen, Weesgeneesmiddelen
- Lancering gezamenlijke routekaart Weesgeneesmiddelen (17-11-2022).
- Geneesmiddelenonderzoek: Europa verliest terrein aan China en VS (15-11-2022).
Vivli – Center for Global Clinical Research Data
- Vivli To Expand Due To New Data-Sharing Policy Affecting NIH-Funded Research (16-11-2022). Clinical Research News.
- Ga naar website Vivli
Wet kwaliteit klachten en geschillen zorg (Wkkgz), Kwaliteitsregistraties
ZonMw
- Onderzoekers en ervaringsdeskundigen werken samen aan onderzoek naar coronavaccinatie bij nierpatiënten (16-11-2022).
- Mapping integrity: a scientific and personal challenge (z.d.).
Overig
- Weekend reads: ‘Illegal practices in palaeontology’; ‘a fake badge of integrity’; researcher jailed (19-11-2022). Retraction Watch.
- Invited Peer Commentary: Research Site Anonymity in Context (17-11-2022). Journal of Empirical Research on Human Research Ethics.
- The Ins and Outs of Digital Twins (15-11-2022). Applied Clinical Trials.
- Linked research hubs train students to tackle societal challenges (15-11-2022). Nature.
- Authorship disputes and patient research participation: collaborating across backgrounds (10-11-2022). Research Ethics.
- To Fight Misinformation, We Need to Teach That Science Is Dynamic (26-10-2022). Scientific American.
- The Pandemic Uncovered Ways to Speed Up Science (25-10-2022). WIRED.
- mRNA drugs with a built-in ‘copy machine’ could lead to safer, more effective therapies (18-11-2022). STAT.
- Medieval physicians understood the ‘Placebo Effect’, study finds (16-11-2022). Medievalists.net.
- Minister grijpt in: belangen wetenschappers openbaar na onduidelijkheid over bijbanen (14-11-2022). NOS.
- Brain implants that translate paralyzed patients’ thoughts into speech creep closer to reality (08-11-2022). STAT.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties