Uitgelicht en gespot op internet (week 21, 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.
Vergeet niet om ook de ‘Consultations‘-overzichtspagina (consultations.bontrop.com) en de ‘Events‘ overzichtspagina (events.bontrop.com) te bezoeken. Er zijn namelijk weer een aantal nieuwe publieke consultaties en evenementen toegevoegd, waaronder het MLCF Symposium: data voor een lerend zorgsysteem: praktijken, beleidsontwikkelingen en waarden (1 juli 2022).
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG)
- Questions and Answers for the two sets of Standard Contractual Clauses (updated 25-05-2022). European Commission.
- EDPB adopts Guidelines on calculation of fines & Guidelines on the use of facial recognition technology in the area of law enforcement (16-05-2022).
Clinical trials, Clinical Trials Regulation (CTR)
- Transition to new European clinical trials info system starts slowly (27-05-2022). Endpoints News
- Hope and hype: psychedelic drugs still to prove value in clinical trials (27-05-2022). Clinical Trials Data.
- Clinical Trial Upgrades Will Open Care Up to More People (26-05-2022). WebMD.
- Validity of event-free survival as a surrogate endpoint in haematological malignancy: Review of the literature and health technology assessments (juli 2022). Critical Reviews in Oncology/Hematology.
- Surrogate Endpoints, Fewer Trials Continue to Back Novel Drug Approvals (23-05-2022). WCG CenterWatch.
- NASEM Calls for Action by FDA, NIH to Improve Trial Diversity (23-05-2022). WCG CenterWatch.
- Cytel Earns Trial of the Year Award for COVID-19 Platform Trial (23-05-2022). WCG CenterWatch.
- The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory (21-05-2022). Trials.
- Complex Clinical Trials – A decade of innovation in clinical research (19-05-2022). EFPIA.
- AmerisourceBergen Launches Clinical Trial Navigator to Bolster Equitable and Accessible Community-Based Research Opportunities Nationwide (23-05-2022). Business Wire.
Dierexperimenteel onderzoek
- Newsletter no. 3-2022 from Norecopa (25-05-2022).
- Zienswijze cumulatief ongerief (24-05-2022). Nationaal Comité advies dierproevenbeleid.
Dutch Association of Research Quality Assurance (DARQA)
Dutch Oncology Research Platform (DORP)
European Medicines Agency, New antimicrobial medicines
- EMA guidance supports development of new antibiotics (24-05-2022).
- Evaluation of medicinal products indicated for treatment of bacterial infections (updated 24-05-2022).
- Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (24-05-2022).
- Updated Guidance on Clinical Trials for Antimicrobials (26-05-2022). Applied Clinical Trials
- EMA releases final guideline on antibacterial drug development (24-05-2022). Regulatory Focus.
- Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO (26-05-2022). Regulatory Focus.
- Clinical Trials Highlights – May 2022 (25-05-2022).
- EMA medical terms simplifier (updated 25-05-2022).
- Report Admonishes EMA Efforts to Reform Trial Transparency (23-05-2022). Applied Clinical Trials.
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG (België)
International Council for Harmonization (ICH)
In Vitro Diagnostics Regulation (IVDR)
- CCMO themapagina ‘Prestatiestudies naar in-vitro diagnostica (IVDR)’
- Public health: Stronger rules for placing medical tests on the market (25-05-2022). Press release European Commission.
- Vanaf vandaag strengere regels voor in-vitro diagnostica (27-05-2022). Inspectie Gezondheidszorg en Jeugd (IGJ).
- MDCG sets out transition periods for legacy diagnostics post-IVDR (24-05-2022). Regulatory Focus.
- IVDR implementation day overshadowed by lack of notified bodies, risks to patients (26-05-2022). Regulatory Focus.
- Happy IVDR day! (26-05-2022). Medicaldeviceslegal.
- The EU IVDR is here! (26-05-2022). BioSlice Blog, Arnold & Porter.
- Wake up to the IVDR! Today, the 26th of May, is the ‘Date of Application’, the date the new IVDR goes live (26-05-2022). Qserve.
- White paper: IVD Medical Devices Clinical Performance Evaluation Studies. EMERGO by UL.
- Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force. HemaSphere: June 2022 – Volume 6 – Issue 6 – p e724.
Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG)
Medical Device Regulation (MDR), Medical Devices
- MDCG 2022-10 – Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
- Euro Convergence: SSCP expert lists common mistakes device manufacturers make (26-05-2022). Regulatory Focus.
Netherlands Research Integrity Network (NRIN)
Nieuwsbrief voor Goede Onderzoekspraktijken
Privacy
- Information and Privacy Commissioner of Ontario (Canada): Ripe for public debate: Legal and ethical issues around de-identified data (17-05-2022).
Real World Evidence (RWE)
- Use of Real-World Evidence in the UK (25-05-2022). BioSlice Blog, Arnold & Porter.
- Real world evidence: Lessons learned from an FDA pilot show the limits of emulating RCTs (16-05-2022). Endpoints News.
Stichting MLC Foundation (MLCF)
Universiteiten van Nederland
U.S. Food and Drug Administration (FDA), Verenigde Staten
- Final guidance: Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Clinical/Medical (27-05-2022).
- Draft guidance: Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1) (24-05-2022).
- Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020. JAMA Netw Open. 2022;5(5):e2212454.
- House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections (25-05-2022). Regulatory Focus.
- Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation (23-05-2022). Regulatory Focus.
Vereniging Innovatieve Geneesmiddelen
- Terugblik VIG Talk: Nieuwe manieren van samenwerken tussen academische centra en bedrijven (24-05-2022).
- Medicijnen antwoord op uitdagingen EZK (24-05-2022).
World Health Organization (WHO)
- We Need Better Clinical Trial Systems before the Next Pandemic: The World Health Assembly’s Resolution Is a Good First Step (26-05-2022). Center for Global Development.
- Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination (24-05-2022). Draft resolution proposed by Argentina, Peru, United Kingdom of Great Britain and Northern Ireland.
- WHO member states pledge to tackle research waste (25-05-2022). TranspariMED.
- WHA clinical trial resolution: draft text now public (24-05-2022). TranspariMED.
ZonMw
Overige berichten
- Weekend reads: Female driver stereotypes; ‘stealth research’; AI comes to fake scientific images (28-05-2022). Retraction Watch.
- Biomarker ‘roadmaps’ and the future of cancer R&D; Curtain raises on #ASCO22; Pfizer, Novartis tackle drug access; and more (28-05-2022). Endpoints News
- Critical appraisal of artificial intelligence-based prediction models for cardiovascular disease, European Heart Journal, 2022;, ehac238.
- Perceptions and behavior of clinical researchers and research support staff regarding data FAIRification (27-05-2022). Scientific Data.
- Parallel publication of articles and congress presentations for industry-sponsored research: strategies for success. Curr Med Res Opin. 2022 May 27:1-6.
- Open innovation: A paradigm shift in pharma R&D? (26-05-2022). Drug Discovery Today.
- eReg Adoption a Challenge for Sites, But Worth the Investment, Experts Say (23-05-2022). WCG CenterWatch.
- Trouble Ahead: Warning Signs Sites Should Heed to Increase Success (23-05-2022). WCG CenterWatch.
- Developing a competency framework for health research ethics education and training (23-05-2022). Journal of Medical Ethics 2022;48:391-396.
- Progress toward Pig-to-Human Xenotransplantation (19-05-2022). NEJM.
- Whole-Body/Head Transplantation: Personal Identity, Experimental Surgery, and Bioethics (11-05-2022). The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine.
- Use of Electronic Patient Data in Research (maart 2011). AMA Journal of Ethics.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties