Uitgelicht en gespot op internet (week 19, 2022)
Hierbij ontvangt u een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Ook zijn er weer nieuwe bijeenkomsten en consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Advanced therapy medicinal products (ATMP), Genetically modified organisms (GMO)
Algemene verordening gegevensbescherming, WGBO
- Adequaatheidsbesluiten onder de AVG (13-05-2022). OpenRecht.
- Persoonsgegevens zijn geen eigendom van de burger (10-05-2022). iBestuur.
Biobanking, Organoids
Clinical trials, Decentralized clinical trials, Informed consent, Representativiteit, Results reporting
- Evaluating the evaluators – Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicators, and direct measure of high risk errors (juni 2022). Contemporary Clinical Trials.
- Leveraging baseline covariates to analyze small cluster-randomized trials with a rare binary outcome (11-05-2022). arXiv.
- Avoid Deviations by Making Protocol Review a Team Effort (09-05-2022). WCG CenterWatch.
- Give Us a Voice: Sites Clamor for a Say on Vendor Selection (09-05-2022). WCG CenterWatch.
- Access to information on drug trials in Europe is getting worse, new report warns (06-05-2022). TranspariMED.
- Designing clinically useful psychopharmacological trials: challenges and ways forward (04-05-2022). The Lancet Psychiatry.
- Inadequate reporting quality of registered genome editing trials: an observational study (02-05-2022). BMC Medical Research Methodology.
- Nailing the First Impression: How to Wow Sponsors at Site Evaluation Visits (02-05-2022). WCG CenterWatch.
College ter Beoordeling van Geneesmiddelen (CBG)
De Jonge Akademie
Dutch Oncology Research Platform
- DORP draagt bij aan CCMO Project Patiëntenparticipatie in klinisch onderzoek – een update (13-05-2022).
- Terugblik op tweede werkconferentie Cohorten (12-05-2022).
European Medicines Agency (EMA)
Gunstbetoon
International Council for Harmonization (ICH)
- ICH Plans Drug Development Guideline to Boost Trial Design (09-05-2022). WCG CenterWatch.
- Pharmaceutical industry groups suggest ICH Q9 changes (06-05-2022). Regulatory Focus.
Nieuwsbrief voor Goede Onderzoekspraktijken
Regulatory Science Network Netherlands (RSNN)
- RSNN annual workshop 2021 report.
- RSNN workshop 2021: presentation files and recording now available (17-12-2021).
Society for Clinical Data Management (SCDM)
Society for Clinical Research Sites (SCRS)
- SCRS Tackles Workforce Challenges with New Site Toolkit (09-05-2022). WCG CenterWatch.
- Diversity Site Assessment Tool – DSAT.
U.S. Food and Drug Administration (FDA)
- FDA sheds light on conducting human radiolabeled mass balance studies (10-05-2022). Regulatory Focus.
- FDA Declines to Disqualify Minneapolis Investigators and IRB from Running Trials (09-05-2022). WCG CenterWatch.
- FDA Guidances Focus on Trials of Crohn’s Disease, Ulcerative Colitis Drugs (02-05-2022). WCG CenterWatch.
ZonMw
Overige berichten
- Changes to pediatric, orphan drug regulations on European horizon (11-05-2022). Regulatory Focus.
- Drug repurposing to overcome microbial resistance (11-05-2022). Drug Discovery Today.
- Superb supervision: A pilot study on training supervisors to convey responsible research practices onto their PhD candidates (10-05-2022). Accountability in Research.
- Collaborative university–industry R&D practices supporting the pharmaceutical innovation process: Insights from a bibliometric review (10-05-2022). Drug Discovery Today.
- What to do when an academic journal rejects your article (08-05-2022). THE Campus.
- TMF Development Group Joins CDISC to Create Better Model (02-05-2022). WCG CenterWatch.
- IQVIA Institute Analyzes Unprecedented Speed of COVID-19 Vaccine Trials (02-05-2022). WCG CenterWatch.
- Nearly One-Quarter of Postmarket Trial Reports Were Late or Not Filed in Fiscal 2020 (02-05-2022). WCG CenterWatch.
- Ivermectin for COVID-19: Addressing Potential Bias and Medical Fraud (17-01-2022). Open Forum Infectious Diseases.