Uitgelicht en gespot op internet (week 26 & 27, 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.
De Boekenplank is vernieuwd en ook zijn er nieuwe publieke consultaties en evenementen toegevoegd aan de ‘Events’ en ‘Consultations’-overzichtspagina’s. Vergeet dus niet om ook daar een kijkje te nemen.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
Clinical research, Consent
- Apps in healthcare and medical research; European legislation and practical tips every healthcare provider should know (september 2023). International Journal of Medical Informatics.
- Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development (04-07-2023). Pharmaceutical Statistics.
- The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials (27-06-2023). Ethics & Human Research.
- The small trial problem. Trials 24, 426 (2023).
- Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions. Trials 24, 424 (2023).
- Trial Participation and Outcomes Among English-Speaking and Spanish-Speaking Patients With Appendicitis Randomized to Antibiotics. A Secondary Analysis of the CODA Randomized Clinical Trial (28-06-2023). JAMA Surgery.
- Ethical research when abortion access is legally restricted. Risks and benefits of some clinical research may be altered (22-06-2023). Science.
- Research ethics committee members’ perspectives on paediatric research: a qualitative interview study. Research Ethics. 2023. Online first, 12 June 2023.
- Further considerations for placebo controls in surgical trials. Trials 24, 391 (2023).
- Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines) (07-03-2020). The Lancet.
- Ethical Considerations in Informed Consent (25-03-2023). Ethics (working title).
- The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines. Front Med (Lausanne). 2022 Sep 16;9:966220.
| Clinical Trials Regulation (CTR)
Clinical Trials Coordination Group (CTCG)
ICON |
CTR, MDR, IVDR, WMO
Clinical Trials Transformation Initiative
Committee on Publication Ethics (COPE)
- Dealing with concerns about the integrity of published research (28-06-2023). Version 1: June 2023.
- New flowcharts: ethical concerns in data publication (26-06-2023).
Council for International Organizations of Medical Sciences (CIOMS)
Dierexperimenteel onderzoek
EU Geneesmiddelenwetgeving
European Health Data Space (EHDS)
- The European health data space: Too big to succeed? (september 2023). Health Policy.
- TEHDAS identifies needs for recommendations on cross-border collaboration between health data access bodies (05-07-2023).
- TEHDAS’ proposals for the implementation of EHDS technical infrastructure (04-07-2023).
European Medicines Agency (EMA)
- Phasing out of extraordinary COVID-19 regulatory flexibilities (06-07-2023).
- Presentaties beschikbaar van
- Clinical Trials Information System Webinar: Second Year of Transition (04-07-2023).
- European Medicines Agency (EMA) Patients’ and Consumers’ (PCWP) and Healthcare Professionals’ (HCPWP) Working Parties joint meeting (28-06-2023).
- European Medicines Agency (EMA) Patients’ and Consumers’ (PCWP) Working Party meeting (27-06-2023).
- Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use (26/27-06-2023).
- ACT EU multi-stakeholder platform kick-off workshop (22/23-06-2023).
Future Affordable Sustainable Therapy Development (FAST)
Health RI
- Nationale initiatieven voor een gezondheidsdata-infrastructuur uit Duitsland, Zwitserland en Nederland ontmoeten elkaar in Berlijn, juni 2023 (06-07-2023).
- Jaarbeeld 2022.
International Council for Harmonisation (ICH)
- ICH reflection paper on integrating real-world evidence into regulatory decision-making (06-07-2023). EMA.
- ICH paper calls for ‘stepwise’ harmonization of RWE (07-07-2023). Regulatory Focus.
Kunstmatige Intelligentie (KI)
- OECD (2023), Artificial Intelligence in Science: Challenges, Opportunities and the Future of Research, OECD Publishing, Paris.
- Responsible AI Guide . Consideratie.
- Website – The Foundation for Best Practices in Machine Learning
- Large language model AI chatbots require approval as medical devices. Nat Med (2023).
- The ethics of disclosing the use of artificial intelligence tools in writing scholarly manuscripts (15-06-2023). Research Ethics.
- Artificial intelligence in lung cancer diagnostic imaging: a review of the reporting and conduct of research published 2018–2019 (06-06-2023). BJR Open.
Lygature
Netherlands Reproducibility Network (NLRN)
- The NL Reproducibility Network (NLRN)
The Netherlands Reproducibility Network (NLRN) is a national peer-led consortium with the goal to increase the quality and efficiency of research in the Netherlands by coordinating, supporting and strengthening initiatives on reproducibility and transparency in all scholarly disciplines.
NHS Health Research Authority (HRA)
- One-stop-shop for artificial intelligence and digital regulations for health and social care launched (12-06-2023).
- HRA Latest – June 2023 (30-06-2023).
Nieuwsbrief voor Goede Onderzoekspraktijken
Nuffield Council on Bioethics
Pandemics
- Preparing for Disease X (26-05-2023). The Lancet Infectious Diseases.
- Disease X: Can the next pandemic vaccine be developed in 100 days? – VaccinesToday (08-03-2023). Vaccines Today.
- Report: ‘The Ethics of Controlled Human Infection Model Studies for Mitigating Pandemic Risks’. Ethics of Controlled Human Infection Model Studies for Mitigating Pandemic Risks (25-04-2023). University of Oxford.
Patientenparticipatie
Pharma.be
- Meer transparantie in samenwerking tussen farma, zorg en patiënten (28-06-2023).
- Onderzoek naar nieuwe geneesmiddelen is geen doel op zich. Het moet de bevolking ten goede komen (27-06-2023).
US Food and Drug Administration’s (FDA)
- Final guidance: Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for Industry (28-06-2023).
- Final guidance: Study Data Technical Conformance Guide – Technical Specifications Document (26-06-2023).
- Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused drug development(07-07-2023). Regulatory Focus.
- DIA: Experts call for more clarity on reporting requirements in FDA’s DCT guidance (30-06-2023). Regulatory Focus.
- FDA issues first psychedelic drug trial guidance(28-06-2023). Regulatory Focus.
Vereniging Innovatieve Geneesmiddelen
- ‘Passende zorg kan alleen met breed beschikbare data’ (04-07-2023).
- Whitepaper Gezondheidsdata VIG (05-07-2023).
Overig
- Weekend reads: NIH defunds Colombian monkey facility; Carlo Croce loses another court battle; ‘peer review is porous’ (08-07-2023). Retraction Watch.
- Weekend reads: A professor who plagiarized his students; how many postgrads in China think it’s OK to fake data; fighting fraud (01-07-2023). Retraction Watch.
- The effectiveness of peer review in identifying issues leading to retractions (august 2023). Journal of Informetrics.
- Publisher blacklists authors after preprint cites made-up studies (07-07-2023). Retraction Watch.
- What do Retraction Notices Reveal About Institutional Investigations into Allegations Underlying Retractions?. Sci Eng Ethics 29, 25 (2023).
- How can universities and journals better work together on research misconduct? (28-06-2023). Retraction Watch.
- Evaluating the completeness of the reporting of abstracts since the publication of the CONSORT extension for abstracts: an evaluation of randomized controlled trial in ten nursing journals. Trials 24, 423 (2023).
- European Skew in Genetic Research Databases Won’t Abate Without More Concerted Effort (30-06-2023). Bill of Health.
- Delivering on NIH data sharing requirements: avoiding Open Data in Appearance Only. BMJ Health & Care Informatics 2023;30:e100771. doi: 10.1136/bmjhci-2023-100771.
- Commitments for Ethically Responsible Sourcing, Use, and Reuse of Patient Data in the Digital Age: Cocreation Process. J Med Internet Res. 2023 May 5;25:e41095.
- Personal data in biomedical research. J R Coll Physicians Edinb. 2023 Jun 9:14782715231175001.
- Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness (23-06-2023). JAMA.
- Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations. Adv Ther. 2023 Apr 5;40(5):2147–85.
- A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry. Ther Innov Regul Sci. 2023 Apr 1. Epub ahead of print.
- The ISoP PatEG-SIG* for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed. Drug Saf (2023).
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties