Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet. Er zijn ook weer nieuwe evenementen en publieke consultaties toegevoegd aan de Events-pagina en de Consultations-pagina.
Je kunt met mij linken via LinkedIn en sinds 1 november ook via Mastodon.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Associatie van Contract Research Organisaties in Nederland (ACRON)
Combination Products
Clinical trials, Platform trials
- Public consultation: Concept paper on platform trials (11-11-2022). European Medicines Agency.
- DIA Global Forum. Driving insights to action (November 2022).
- More Than One Way to Crack a Walnut: Four Fundamental Components of a Successful Decentralized Clinical Trial
- Data Standards Optimize Patient-Centric Clinical Trials
- Technology’s Burdens and Blessings for Patients in DCTs
- Right Time for Roadmap to Harmonizing RWE? EU Industry Perspective on Future Directions.
- Applied Clinical Trials November 2022 Issue (PDF) (10-11-2022).
- Mobilizing and Maintaining Clinical Trials in Midst of War (10-11-2022). Applied Clinical Trials.
- The Implications of Inflation for Drug Development (10-11-2022). Applied Clinical Trials.
- Implementing Numeric Rating and Visual Analog Scales in an eCOA Solution (10-11-2022). Applied Clinical Trials.
- When Does Patient Centricity Equal Burden? (10-11-2022). Applied Clinical Trials.
- Therapeutic Innovation & Regulatory ScienceVolume 56, issue 6, November 2022
- How to Operationalize Oncology Trials with a Decentralized Approach (11-11-2022). Applied Clinical Trials.
- Better pay for clinical trial participants: in conversation with Gunnar Esiason (10-11-2022). Clinical Trials Arena.
- Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience (07-11-2022). American Journal of Medical Genetics Part A.
- Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials (02-11-2022). PLOS ONE 17(11): e0275823.
- Benefits of Streamlined Point-of-Care Trial Designs: Lessons Learned From the UK RECOVERY Study. JAMA Intern Med. 2022 Oct 24. doi: 10.1001/jamainternmed.2022.4810.
Dutch Clinical Research Foundation (DCRF)
Dutch Oncology Research Platform (DORP)
European Clinical Research Infrastructrure Network (ECRIN)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Europe’s share of global medicines R&D shrinks by a quarter in 20 years – as sector’s declining trends continue (07-11-2022).
- Euro Roundup: EFPIA proposal seek to reverse EU’s shrinking share of R&D pie (10-11-2022). Regulatory Focus.
European Medicines Agency (EMA)
- Presentations – ACT EU multi-stakeholder meeting on decentralised clinical trials (08-11-2022).
- Terugkijken: ACT EU multi stakeholder workshop on Decentralised Clinical Trials. via YouTube.
Flanders.bio
Health-RI
- The Netherlands is good at collecting data but not at (re)using it (9 November 2022).
- Building blocks of a health data infrastructure: together with and for data users and data holders (8 November 2022).
- Trust and transparency are essential for sharing health data (8 November 2022).
- International data and sample sharing. What can we learn from these international data-sharing projects? (7 November 2022).
- Rapport met inzichten in corona komt veel te laat: ‘En dat is tragisch. Een gemiste kans’ (07-11-2022). NRC.
- Obstacles removal trajectory
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ICH M11 guideline
Loket Gentherapie
Research integrity
Methodology, Statistics
- Shiny app for Sample Size Justification
This Shiny app accompanies the paper ‘Sample Size Justification’ by Daniël Lakens. … The main goal of this app and the accompanying paper is to guide you through an evaluation of the informational value of a planned study. After filling out this form you can download a report of your sample size justification. - Bias? Clarifying the language barrier between epidemiologists and economists (03-11-2022). Health Services and Outcomes Research Methodology.
US Food and Drug Administration (FDA)
- Should Your Child Participate in a Clinical Trial? (9-11-2022).
- FDA drafts guidance on ‘sameness’ evaluations for generic drugs (09-11-2022). Regulatory Focus.
- New Federal Incentives for Diversity in Clinical Trials. N Engl J Med. 2022 Oct 13;387(15):1347-1349. doi: 10.1056/NEJMp2209043. Epub 2022 Oct 8.
Weesgeneesmiddelen, Orphan medicines
- The Revision of the Orphan Medicines Regulation Is an Opportunity. Will Europe Seize it? (11-11-2022). EuropeBio
- ‘Dogma’ About Innovation vs. Access Impeding EU Fixes for Rare Diseases (10-11-2022). Applied Clinical Trials.
ZonMw
- Onderzoeksintegriteit bij hbo’s: nemen onderzoekers en bestuurders hun verantwoordelijkheid?
- Nieuwe kernset generieke PROMs implementeren in de dagelijkse praktijk: 7 projecten van start (07-11-2022).
- Subsidieoproep: Jongerennetwerk Ervaringskennis in Onderzoek
Overig
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties