Uitgelicht en gespot op internet (week 17, 2022)
Hierbij 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.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming
- GA4GH GDPR Brief: Federated analysis for responsible data sharing under the GDPR (29-04-2022).
- Differential Data Protection Regimes in Data-Driven Research: Why the GDPR Is More Research-Friendly Than You Think (14-07-2021). German law Journal.
Amsterdam UMC
- Research Roadmap
“This research roadmap offers all researchers in Amsterdam UMC structured information on setting up, carrying out and completing scientific research, including clinical trials. What requirements do you have to meet for each kind of research project? And what kind of support is available from Amsterdam UMC?“
CCMO: EU-verordening voor geneesmiddelenonderzoek (CTR)
CCMO: EU-verordening betreffende medische hulpmiddelen voor in-vitro diagnostiek (IVDR)
- Informatie EU-verordening prestatiestudies naar in-vitro diagnostica beschikbaar op CCMO-website (29-04-2022).
- Overzicht in te dienen documenten voor IVD-prestatiestudies (28-04-2022).
- Standaardonderzoeksdossier IVD-prestatiestudies A1. Model aanbiedingsbrief (28-04-2022).
- Explanatory note to flowchart for performance studies (28-04-2022).
- Flowchart ongewenste voorvallen prestatiestudies met IVD (28-04-2022).
MDCG: EU-verordening voor medische hulpmiddelen (MDR)
- MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (April 2022).
- MDCG issues guidance to help define ‘borderline’ products (28-04-2022). Regulatory Focus.
Europees Unie, Office of the United States Trade Representative (USTR), Disclosures of clinical trial data, Transparency
“… Moreover, changes to European Medicines Agency (EMA) policy regarding disclosures of clinical trial data, including potential disclosure of confidential commercial information submitted to EMA by pharmaceutical firms seeking marketing authorization, are also of concern to stakeholders. The United States continues to engage with the EU and individual Member States on these matters.”
bron: pag. 180, USTR ‘2022 National Trade Estimate Report on Foreign Trade Barriers’
European Clinical Research Infrastructure Network (ECRIN)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
België: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG), Oorlog in Oekraine en klinisch onderzoek
Health-RI
ICH E8(R1) General Considerations for Clinical Studies
- The ICH E8(R1) Introductory Training Presentation now available on the ICH website (28-04-2022). ICH.
- ICH E8 General considerations for clinical studies. EMA.
Date for coming into effect 14 April 2022. - ICH E8(R1) Final Version Released in April 2022. Cyntegrity.
Pharma.be
Society for Clinical Data Management (SCDM)
- CDS Topic Brief: The 5Vs of Clinical Data, Version 1 (March 2022).
- CDS Topic Brief: Decentralized Clinical Trials (DCTs), Version: #1, Release: April 2020.
UK Research Integrity Office (UKRIO)
Verenigde Staten, US Food and Drug Administration (FDA)
- The Food and Drug Administration Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments Fiscal Year 2020.
- Newly added guidance documents
- FDA finalizes guidance for drugs and biologics containing nanomaterials (25-04-2022). Regulatory Focus.
- Randomized Trials Needed to Evaluate PI3K Drugs Before Approval Submissions (25-04-2022). WCG CenterWatch.
- Sites Need to Confront Eligibility Criteria Barriers to Diversity in Oncology (25-04-2022). WCG CenterWatch.
- GAO highlights lack of policies to combat political interference at health agencies (25-04-2022). Regulatory Focus.
Overige berichten
- Weekend reads: Surgeon on trial over experiments; hydroxychloroquine-promoting doctor reprimanded; questions about concussion research (30-04-2022). Retraction Watch.
- Prevalence of responsible research practices among academics in The Netherlands [version 1; peer review: awaiting peer review]. F1000Research 2022, 11:471.
- Maverick French Covid doctor reprimanded over ‘breaches’ in clinical trials (27-04-2022). The Local France.
- Surgeon on trial in Sweden over experimental windpipe transplants (27-04-2022). The Guardian.
- Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond (26-04-2022). Front. Med.
- Priorities at Sites Change as Trial Landscape Becomes More Challenging (25-04-2022). WCG CenterWatch.
- Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data (22-04-2022). PLOS Global Public Health 2(4): e0000261.
- Scientists Question Data Behind an Experimental Alzheimer’s Drug (18-04-2022). The New York Times.
- Data-Sharing in the Time of COVID – Could Researchers Agree to Use a Common Clinical Trial ‘Repository’? (15-04-2022). Health Policy Watch.
- Time to re-think the divide between academic and support staff (14-04-2022). Nature.
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