Uitgelicht en gespot op internet (week 1, 2022)
Allereerst de beste wensen voor 2022! Ook in deze eerste week van het nieuwe jaar weer een -kort- overzicht van berichten en artikelen die de afgelopen tijd zijn gespot op het internet.
Vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te bezoeken.
‘Uitgelicht en gespot op internet‘ is een supplement van de Nieuwsbrief voor Goede Onderzoekspraktijken.
Centrale Commissie Dierproeven (CCD)
Clinical Trials Regulation (CTR)
Op 7 januari is door de Europese Commissie bekend gemaakt, de:
De uitvoeringsverordening moet nog in het Publicatieblad van de Europese Unie verschijnen.
Data management, Research ICT
Digital Health Technologies, Remote clinical trials, Decentralized Clinical Trials
- Digital health tech in clinical investigations: FDA issues draft guidance (05-01-2022). Regulatory Focus.
- FDA Offers Direction on Using Digital Health Solutions to Gather Trial Data Remotely (03-01-2022). WCG CenterWatch.
- New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials (29-12-2021). JD Supra.
- Decentralized Clinical Trials: How about your data (z.d.). Clin-Q.
European Data Protection Board (EDPB)
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Health data
In Vitro Diagnostic Regulation (IVDR)
Medicines and Healthcare products Regulatory Agency (MHRA)
- Guidance: Clinical trials for medicines: apply for authorisation in the UK (updated 07-01-2022). Included information about the new combined review service.
- Guidance: Notify the MHRA about a clinical investigation for a medical device (updated 04-01-2022). Uploaded guidance on the MHRA and HRA coordinated assessment pathway.
Participanten
- Confessions of a ‘human guinea pig’: Why I’m resigning from Moderna vaccine trials (04-01-2022). STAT.
- Bah humbug! Association between sending Christmas cards to trial participants and trial retention: randomised study within a trial conducted simultaneously across eight host trials (14-12-2021). BMJ.
Research integrity
Stichting Code Geneesmiddelenreclame (CGR), Stichting Gedragscode Medische Hulpmiddelen (GMH)
- CGR nieuwsbrief Nr. 1/2022 Redelijke maximum uurtarieven 2022.
- GMH Nieuwsbrief 1 – 5 januari 2022 (de definitieve maximum uurtarieven).
US Food and Drug Administration (FDA)
- FDA issues draft guidance on assessing physiologic closed-loop control devices (06-01-2022). Regulatory Focus.
- FDA temporarily halts inspections due to omicron (05-01-2022). Regulatory Focus.
- Draft Guidance for Industry and Food and Drug Administration Staff: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (23-12-2021).
Overige berichten
- Weekend reads: A museum of scientific misconduct?; authorship misconduct; uproar over renamed phyla (08-01-2022). Retraction Watch.
- Shreddergate! And an idea for a Museum of Scholarly Misconduct (06-01-2022). Statistical Modeling, Causal Inference, and Social Science.
- Increased Digitization in Clinical Trials: Expectations for the Year Ahead (06-01-2022). Applied Clinical Trials.
- Radboudumc-hoogleraar neemt voortouw: wetenschap moet duurzamer (06-01-2022). Skipr.
- Leiden verdiept samenwerking op gebied van ict voor onderzoek (06-01-2022). Skipr.
- The role of collegiality in academic review, promotion, and tenure (05-01-2022). bioRxiv.
- How fake science is infiltrating scientific journals (05-01-2022). The Sydney Morning Herald.
- Elizabeth Holmes verdict: researchers share lessons for science (04-01-2022). Nature.
- Clinical Research Trends & Insights for 2022 (03-01-2022). WCG CenterWatch.
- ICH releases revised Q9 guideline to improve risk assessments (03-01-2022). Regulatory Focus.
- ‘This is really ridiculous’: An author admitted plagiarism. His supervisor asked for a retraction. The publisher said, “nah.” (03-01-2021). Retraction Watch.
- Research done wrong: A comprehensive investigation of retracted publications in COVID-19 (02-01-2022). Accountability in Research.
- At what point does incompetence become fraud? (januari 2022). JLCederblom, via Medium.
- Target and actual sample sizes for studies from two trial registries from 1999 to 2020: an observational study (30-12-2021). BMJ Open.
- Unreliable Science in Media as Peer-Review Breaks Down (30-12-2021). The Click.
- Addressing disorder in scholarly communication: Strategies from NISO Plus 2021 (27-12-2021). The 2021 NISO Plus Conference: Global connections and global conversations.
- Biomarker discovery studies for patient stratification using machine learning analysis of omics data: a scoping review (06-12-2021). BMJ Open.
- 3 things to know about the importance of post-approval research and development (06-12-2021). PhRMA
- The new normal? Redaction bias in biomedical science (01-12-2021). Royal Society Open Science.
- Can quality management drive evidence generation? (02-11-2021). Clinical Trials.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties