Hierbij een overzicht van actualiteiten en nieuwsberichten die de afgelopen periode zijn gespot op het internet.
Ook zijn er weer nieuwe events en publieke consultaties toegevoegd aan de ‘Events‘ pagina en de ‘Consultations‘-pagina.
Biobanken
Clinical Data Interchange Standards Consortium
- CDISC and REDCap Work Together to Foster More Meaningful Clinical Research for Academics (21 oktober 2021).
- CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward (19 oktober 2021).
Clinical trials
- New Trial Approaches Have Strong Benefits, but Industry Worries about Complexities (1 november 2021). WCG CenterWatch.
- Riding the Wave: Key Site Considerations for Cell and Gene Therapy Research (1 november 2021). WCG CenterWatch.
Clinical trials, Genetically Modified Organisms (GMO), EudraLex
- Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified, version 5 (November 2021).
- Common Application form for clinical research with human cells genetically modifiedSearch for available translations of the preceding, version 5 (November 2021).
Clinical trial results reporting & data sharing
Data management
Dierproeven
- Lancering Transparantieovereenkomst Dierproeven (2 november 2021). Stichting Informatie Dierproeven.
Dutch Association of Research Quality Assurance (DARQA)
European Medicines Agency (EMA)
- EMA Offers Guidelines for Registry-Based Trials (1 november 2021). WCG CenterWatch.
- Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia (28 oktober 2021).
- Generating high-quality evidence from registry-based studies (26 oktober 2021).
Federatie Medisch Specialisten (FMS)
ICH E6 (R3) Good Clinical Practice
Integrity
- Does the World Need an Academic Integrity Awareness Index? An Interview with Helen Zhang (2 november 2021). The Scholary Kitchen.
- Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial (2 november 2021). BMJ.
- CHECK – Nee, “Pfizergate” betekent niet dat Pfizer studieresultaten over het coronavaccin heeft vervalst (6 november 2021). VRT NWS.
Good Lay Summary Practice (GLSP)
Health Data Research UK (HDR UK)
Inspectie Gezondheidszorg en Jeugd (IGJ)
- Poliovirus gevonden in riool Utrecht Science Park Bilthoven (1 november 2021).
- Erkenning Stamcelbank Nederland ingetrokken (1 november 2021).
National Health and Medical Research Council (Australie)
Nederlandse Kankerregistratie (NKR)
- Synthetische dataset NKR beschikbaar voor onderzoekers (8 oktober 2021).
- Real-world data waardevol, maar niet voor elk doel (29 oktober 2021). Oncologie Vandaag.
Patient-Centered Outcomes Research
Predatory publishers
Quality
Research ethics
Society for Clinical Data Management (SCDM)
TransCelerate BioPharma
Overige
- ‘Pure’ ellende: hoe Open Access ons afhankelijker maakt van grote uitgevers (3 november 2021). Univers.
- Portal Helps Researchers Screen COVID-19 Drug Candidates (2 november 2021). Technology Networks.
- How conspiracists exploited COVID-19 science (1 november 2021). Nature Human Behavior.
- Combine Compensation Models for More Precise Investigator Payments (1 november 2021). WCG CenterWatch.
- The Metascience Movement Needs to be More Self-Critical (31 oktober 2021). PLOS Blogs.
- Open Science verbetert de kwaliteit van de wetenschap (29 oktober 2021). ScienceGuide.
- Comparing regulatory transparency in Europe, the United States and Canada (oktober 2021). TranspariMED.
- Improving transparency of regulatory data at EMA, Health Canada, FDA (29 oktober 2021). Regulatory Focus.
- All in the mind: what the placebo effect looks like in the brain (29 oktober 2021).
- How faculty define quality, prestige, and impact of academic journals. PLoS ONE 16(10): e0257340.
- How Pseudoscience Generated US Material and Device Regulations (september 2021). AMA Journal of Ethics.
Meer actueel nieuws, bijeenkomsten en publieke consultaties