Uitgelicht en gespot op internet (week 46, 2022)

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

• Comparison of adverse event risks in randomized controlled trials with varying follow-up times and competing events: Results from an empirical study (09-11-2022). Statistics in Biopharmaceutical Research.

Algemene verordening gegevensbescherming (AVG)

• Brief regering: Facebook Pages DPIA en HRIA (18-11-2022). Ministerie van Binnenlandse Zaken en Koninkrijksrelaties.
  • HRIA on government Facebook Pages
  • DPIA on government Facebook Pages
• 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)

• Rules of procedure (ROP), Final, 31 October 2022.

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)

• Oratie Peter Mol over kennisuitwisseling tussen wetenschap en medicijnautoriteit (15-11-2022).

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

• Safeguarding research staff “in the field”: a blind spot in ethics guidelines (15-11-2022). Research 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)

• CPME: Europese ruimte voor gezondheidsgegevens moet de medische ethiek en de nationale bevoegdheid respecteren (17-11-2022). KNMG.

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.
  • Euro Roundup: EMA consults on planned update to computerized systems annex of GMP guide (17-11-2022). Regulatory Focus.
• 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

• Building blocks of a health data infrastructure: together with and for data users and data holders (08-11-2022).

Information Commissioner’s Office (ICO) (Verenigd Koninkrijk)

• International transfers: empowering innovation and growth whilst protecting people’s personal information (17-11-2022).

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)

• MSF Clinical Trial Transparency Policy. In October 2022, MSF approved and published its first Clinical Trial Transparency Policy (CTTP) (11-11-2022).

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

• Nature authors can now seamlessly share their data (16-11-2022). Springer Nature Groep.

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 157 (18-11-2022).
• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 156 (15-11-2022).

Research Ethics

• Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight (18-11-2022). Research Ethics.

TransCelerate Biopharma Inc.

• Diversity of Participants in Clinical Trials Solutions

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

• Proefschriften

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.
  • SOPP 8216: Fast Track Development Programs – Designation and Management (16-11-2022).
• 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

• Verslag van een schriftelijk overleg over de reactie op de evaluatie van de Wet kwaliteit klachten en geschillen zorg (Wkkgz) (14-11-2022).

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

News	Events	Consultations
news.bontrop.com	events.bontrop.com	consultations.bontrop.co