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.
Ook zijn de ‘Events’ en ‘Consultations’-pagina’s bijgewerkt en zijn er nieuwe boeken aan de Boekenplank toegevoegd.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
All European Academies (ALLEA)
- ALLEA Publishes 2023 Revised Edition of the European Code of Conduct for Research Integrit (23-06-2023).
- European Code of Conduct for Research Integrity 2023 Revised Edition.
Clinical trials, Clinical research
ClinicalTrials.gov
Decentralized clinical trials (DCTs)
Dutch Association of Research Quality Assurance (DARQA)
- Summary of ICT theme day on audit trails (review) and data integrity, 31 May 2023 (02-06-2023).
- Verslag DARQA GLP webinar “De analyse van klinische samples: raakvlakken met regelgeving (GLP/GCP/GDPR)”, 12 mei 2023 (25-05-2023).
Dutch Clinical Research Foundation (DCRF)
Dutch Oncology Research Platform (DORP)
European Medicines Agency (EMA)
- Q&A: Good clinical practice (GCP) (updated 23-06-2023).
- B.11. According to the applicable EU laws and ICH E6, is it allowed that the sponsor could contract service providers to conduct trial-related tasks, procedures, duties and functions that are under the responsibility of the investigator? Rev. June 2023
- B.18. What are the expectations for productivity applications used in clinical trials? New June 2023
- Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 May 2023, edition 14) (23-06-2023).
- Use of real-world evidence in regulatory decision making – EMA publishes review of its studies (23-06-2023).
- ACT EU: creating a better environment for clinical trials through collaboration (22-06-2023).
Good Clinical Trials Collaborative
- “Time to turn words into action” – a response to O’Shaughnessy review (12-06-2023).
- New film reaffirms importance of good trials and good guidance (25-05-2023).
- Launch of a new tool for funders: Living Roadmap will support stronger coordination of clinical trial responses to epidemics and pandemics (04-05-2023). GloPID-R.
- “Fast tracking informative clinical trials: lessons for mental health” – our commentary in Lancet Psychiatry (06-04-2023).
International Council for Harmonisation (ICH)
Kunstmatige Intelligentie (KI)
- Oh jee, geen enkel LLM foundation model voldoet aan de AI Act, wat nu? (21-06-2023). Internetrecht door Arnoud Engelfriet.
- Open-source AI chatbots are booming — what does this mean for researchers? (20-06-2023). Nature.
- ChatGPT Gaining Foothold in Drug Development, Clinical Trials (20-06-2023). Bloomberg Law.
- Erasmus MC en TU Delft openen eerste AI-ethieklab voor de zorg (16-06-2023). Amazing Erasmus MC.
Nieuwsbrief voor Goede Onderzoekspraktijken
Participatiekompas
- Structurally embedding patient involvement in the health research system: an ongoing quest (25-05-2023). Proefschrift Simone Harmsen.
- Patient involvement in basic rheumatology research at Nijmegen: a three year’s responsive evaluation of added value, pitfalls and conditions for success. BMC Rheumatol 6, 66 (2022).
Patientenparticipatie
- Roles, outcomes, and enablers within research partnerships: A rapid review of the literature on patient and public involvement and engagement in health research. Res Involv Engagem 9, 43 (2023).
- Participatory Research Methods – Choice Points in the Research Process. Journal of Participatory Research Methods, 1(1).
Trials@Home
US Food and Drug Administration’s (FDA)
- Draft guidance: Psychedelic Drugs: Considerations for Clinical Investigations (23-06-2023).
- Final guidance: Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry (22-06-2023).
- Pharmacogenomic data guidance: Industry objects to reporting exploratory studies (21-06-2023). Regulatory Focus.
- In the mind of an ex-FDA investigator – interval audits (20-06-2023). RChase Consulting LLC.
Overig
- Weekend reads: A fraudster is sentenced to prison; how another reinvented himself; RFK Jr.’s retraction, redux (24-06-2023). Retraction Watch.
- Scientists Debut Lab Models of Human Embryos (24-06-2023). The New York Times.
- Data-driven sudden cardiac arrest research in Europe: Experts’ perspectives on ethical challenges and governance strategies (september 2023). Resuscitation Plus.
- Bereidheid van patiënten met kanker voor wearables en apps in klinisch onderzoek en zorg – perspectief voor Trial@Home in de Oncologie! (21-06-2023). CHDR.
- Windpipe Surgeon Jailed In Sweden For Harming Patients (21-06-2023). Barron’s.
- Scientific fraud is rising, and automated systems won’t stop it. We need research detectives (20-06-2023). The Conversation.
- Poor visibility of retracted articles: a problem that should no longer be ignored BMJ 2023; 381 :e072929 doi:10.1136/bmj-2022-072929.
- Global ‘pandemic treaty’: nations wrestle with how to fairly share virus data (19-06-2023). Nature.
- A multidimensional account of social justice for global health research (19-06-2023). Bioethics,
- Human stem-cell-based embryo models prompt ethical questions (19-06-2023). BioNews.
- On the use of non-concurrent controls in platform trials: a scoping review. Trials 24, 408 (2023).
- Patient communication and experiences in cancer clinical drug trials: a mixed-method study at a specialist clinical trials unit. Trials 24, 400 (2023).
- Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis. Trials 24, 403 (2023).
- Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit (11-04-2023). ESMO Open.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties