Uitgelicht en gespot op internet (week 10, 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.

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Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG), WGBO

• Forensic Investigative Genetic Genealogy (10-03-2023). Leiden Law Blog.

Bioethics, Embryos, Human Genome Editing

• Brief regering: Rapportage van de wetenschappelijke resultaten van het ZonMW-project ‘synthetic embryos: an ethical reflection’ (10-03-2023). Minister van Volksgezondheid, Welzijn en Sport.
  • Bijlage: ZonMw Ethiek van Synthetische Embryo’s Rapportage VWS.
• Human genome editing offers tantalizing possibilities – but without clear guidelines, many ethical questions still remain (08-03-2023). The Conversation.

Responding to the Comeback of He Jiankui, ‘The CRISPR Baby Scientist’: Lessons from Criminal Justice Theory

Brexit, Geneesmiddelen

• The Windsor Agreement and supply of medicinal products in Northern Ireland (08-03-2023). BioSlice Blog.

Centrale Commissie Dierproeven (CCD), Dierexperimenteel onderzoek

• Verslag vergadering 27 januari 2023 (08-03-2023).
• Verslag vergadering 16 december 2022 (08-03-2023).
• Verslag vergadering 6 januari 2023 (08-03-2023).
• België gebruikt jaarlijks een half miljoen proefdieren, maar wetenschappers werken aan alternatieven (07-03-2023). EOS Wetenschap.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Format jaarverslag METC (08-03-2023).

Clinical trials, Clinical research

• UK to review trial landscape in light of decline in industry-led research (07-03-2023). Clinical Insider.
• Transparency in conducting and reporting research: A survey of authors, reviewers, and editors across scholarly disciplines. PLOS ONE 18(3): e0270054.
• PedCRIN tool for the biosamples management in paediatric clinical trials. Clin Transl Sci.
• Implementing clinical trial data sharing requires training a new generation of biomedical researchers. Nat Med.
• Les essais plateformes. Therapies.
• Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia. British Journal of Clinical Pharmacology.

Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS) Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 January 2023, edition 10) (08-03-2023). EMA. CTIS newsflash – 10 March 2023. EMA. Human medicines highlights – March 2023 (09-03-2023). EMA. Highlight report – Ninth industry stakeholder platform on research and development support (08-03-2023). EMA.

Computerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI)

• Guideline on computerised systems and electronic data in clinical trials (09-03-2023). EMA.
  Date of coming into effect 6 months after publication
• EMA Q&A addresses submission of data elements for raw data pilot (10-03-2023). Regulatory Focus.

Diversity, Consent, Inclusion, Retention, Representative

• eConsent in clinical trials: what’s new and what’s yet to come? (08-03-2023). Clinical Trials Arena.
• Creating a best practice template for participant communication plans in global health clinical studies. Trials 24, 158 (2023).
• Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis. Trials 24, 164 (2023).
• Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation. Trials 24, 157 (2023).
• Participant recruitment, baseline characteristics and at-home-measurements of cardiometabolic risk markers: insights from the Supreme Nudge parallel cluster-randomised controlled supermarket trial. Trials 24, 159 (2023).
• Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action. Trials 24, 151 (2023).
• Study explores how community engagement can help improve clinical trial diversity (09-03-2023). MedicalXpress.
• Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions—A report from the “Health Equity through Diversity” seminar series. PLOS ONE 18(2): e0281940.
  • Study explores how community engagement can help improve clinical trial diversity (09-03-2023). The Ohio State University Wexner Medical Center.
• Diversiteit in onderzoek: ‘Wees je bewust van verschillen’. Inspiratie voor onderzoekers en beoordelaars van subsidieaanvragen (16-02-2023). ZonMw.
• Enhancing Diversity and Inclusion in Clinical Trials (11-01-2023). Clinical Pharmacology & Therapeutics.

European Federation of Pharmaceutical Industries and Associations (EFPIA)

• From COVID-19 Pandemic to War: Clinical Trial Industry Powers On Under Extreme Conditions (Guest Blog) (08-03-2023).
• Dynamic Regulatory Assessment will support more efficient treatment development for patients: the time to pilot is now (Guest Blog) (02-03-2023).

European CRO Federation (EUCROF)

• Propositions on Remote Source Data Verification and Remote Source Data Review (08-03-2023).

EvidenceHunt

• Nieuwe zoekmachine voor medische wetenschap (02-03-2023). Medisch Contact.
• EvidenceHunt.com
  EvidenceHunt allows you to search for clinical evidence in a quick and effective way. You also have the option to subscribe to weekly e-alerts for your search.

Kunstmatige Intelligentie (KI)

• Navigating the EU AI Act: flowchart (07-03-2023). Burges Salmon.
• The growing influence of industry in AI research. Industry is gaining control over the technology’s future (02-03-2023). Science.
• How to avoid machine learning pitfalls: a guide for academic researchers. arXiv.

Medicines and Healthcare prodsucts Regulatory Agency (MHRA)

• Reflections on the shared commitment to public involvement (10-03-2023). Blog MHRA Inspectorate.

Medische hulpmiddelen

• U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks (02-03-2023). Reuters.
• EMA pilots scientific advice for certain high-risk medical devices (27-02-2023). EMA.

Methodologie, Statistiek

“John Tukey said that the best thing about being a statistician is that you get to play in everyone’s backyard. It’s a great quote. While it more obviously reflects the tendency of applied statisticians (defined broadly) to be involved in lots of studies, it also captures something about statisticians that is often missed – that we are also scientists, delighted in the pursuit of new knowledge.”

bron: Everybody’s backyard (09-03-2023). My 2 cents.

Oncode Institute

• Oncode Special edition March 2023.

Chris De Jonghe: ‘I’ve seen Oncode’s early development only from a distance. Oncode is built after a proven model, Vlaams Instituut voor Biotechnologie (VIB), but at the time, it was not clear how to establish a similar institute in the local Dutch context. It took many years to take off, to get all funders on board and find the right format. But when the first tangible results came out, all struggles turned into energy and enthusiasm. I think it’s fair to say that Oncode exceeded the initial expectations in so many ways, and that is also reflected in the excellent review we received from the International Review Committee.’

Organisation for Economic Co-operation and Development (OECD)

• Ready for the Next Crisis? Investing in Health System Resilience (23-02-2023).

Prinses Máxima Centrum (PMC)

• Beter vindbare data versnelt onderzoek (09-03-2023).

Quality by Design, Risk-Based Quality Management (RBQM), Quality Risk Management (QRM)

• What’s the Difference Between RBQM and QRM in Clinical Trials? (06-03-2023). Cyntegrity.
• A Roadmap to Get Started With Quality by Design in Clinical Trials. DIA Global Forum.

Research integrity

• Why research integrity matters and how it can be improved, Accountability in Research.

Boekenplank

Vaste commissie voor Volksgezondheid, Welzijn en Sport

• Conceptverslag EU-Gezondheidsraad (formele EU-Gezondheidsraad 14 maart 2023) (08-03-2023).

Vereniging Innovatieve Geneesmiddelen

• Grote verandering octrooiwetten (07-03-2023).

Wet zeggenschap lichaamsmateriaal (Wzl)

• Volgens de besluitenlijst van de procedurevergadering van donderdag 9 maart 2023  heeft de vaste commissie voor Volksgezondheid, Welzijn en Sport (VWS) het verzoek van de minister om het plenaire debat over het voorstel voor de Wet zeggenschap lichaamsmateriaal (Kamerstuk 35844) uit te stellen voor kennisgeving aangenomen.

Overig

• Weekend reads: ‘Is economics self-correcting?’; ’20 years of ‘terror’ in the laboratory’; a look at self-citations (11-02-2023). Retraction Watch.
• Pseudowetenschap en kwakinnovatie (08-03-2023). NRC.
• Onethisch, waarschijnlijk illegaal, maar vooral oneerlijk (09-03-2023). Medisch Contact.
• ‘Dosering medicatie bij kinderen vaak op basis van beperkt bewijs’ (07-03-2023). Medisch Contact.
• Defining Malaysia’s health research ethics system through a stakeholder driven approach (02-03-2023). Developing World Bioethics.
• Recommendations for robust and reproducible preclinical research in personalised medicine. BMC Medicine.
• Women’s experiences with using patient-reported outcome and experience measures in routine perinatal care in the Netherlands: a mixed-methods study. BMJ Open 2023;13:e064452. 
• Nature welcomes Registered Reports (22-02-2023). Nature.
• Transparency in conducting and reporting research: A survey of authors, reviewers, and editors across scholarly disciplines. PLOS ONE 18(3): e0270054.

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