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. Er zijn ook weer nieuwe bijeenkomsten en publieke consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Clinical Event Committee (CEC), Data Monitoring Committee (DMC), Endpoint Adjudication Committee (EAC), Safety Assessment Committee (SAC), Steering Committee (SC)
- Safety Assessment Committee (SAC), Data Monitoring Committee (DMC), Steering Committee (SC), Clinical Event Committee (CEC) (31-03-2022). On Biostatistics and Clinical Trials.
- DMC vs EAC: What’s the Difference? (09-03-2022). Advarra.
Clinical research, Clinical trials
- Moving xenotransplantation research into human trials will require adjusting our expectations, researchers say (01-04-2022). STAT.
- Covid-19 two years on: persistent symptoms of clinical trial disruption trouble certain therapy areas (31-03-2022). Clinical Trials Arena.
- Practical steps to identifying the research risk of pragmatic trials (29-03-2022). Clinical Trials.
- Pediatric Research Continues to Experience High Trial Failure, Low Reporting (28-02-2022). WCG CenterWatch.
- DCT Methods Helped Lung Cancer Trial Enrollment as COVID Surged, New Study Shows (28-02-2022). WCG CenterWatch.
- PhRMA Comes Out Against Additional Pediatric Trial Requirements (28-02-2022). WCG CenterWatch.
- Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From the Heart Failure Collaboratory. JAMA Cardiol. Published online March 23, 2022.
- Atuire CA, Salas SP, Wright K, et al. COVID-19 vaccine trials with children: ethics pointers. BMJ Glob Health. 2022 Jan;7(1):e007466. doi: 10.1136/bmjgh-2021-007466.
- Motives and risk perceptions of participants in a phase 1 trial for Hepatitis C Virus investigational therapy in pregnancy. Research Ethics. December 2021.
- Financial incentives for participants in health research: when are they ethical? Swiss Med Wkly. 2022;152:w30166. doi:10.4414/SMW.2022.w30166.
- WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations. Vaccine. 2022 Feb 28:S0264-410X(22)00175-X. doi: 10.1016/j.vaccine.2022.02.038.
- Varadan S, Sirinam S, Limkittikul K, Cheah PY. (2022). The proxy dilemma: Informed consent in paediatric clinical research – a case study of Thailand. Developing World Bioethics, 1– 10. doi: 10.1111/dewb.12341.
- White M, Whittaker RG. Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain. Open Access Journal of Clinical Trials. 2022;14:1-9. doi: 10.2147/OAJCT.S345482.
Clinical trial results reporting
- Where are the results for these 2,272 clinical trials involving children? (29-03-2022). TranspariMED.
- New network supports European institutions with clinical trial reporting (25-03-2022). TranspariMED.
Council for International Organizations of Medical Sciences (CIOMS)
Drug Information Association (DIA)
Dutch Clinical Research Foundation (DCRF)
- Patiëntenparticipatie; We moeten het met elkaar beter gaan doen. En het is nog leuk ook! (28-03-2022).
- [Bijgewerkte] Checklist Lokale Uitvoerbaarheid behorende bij CTR-VGO proces (28-03-2022).
European Health Data Space
European Medicines Agency (EMA)
- CTIS newsflash (25-03-2022).
- Clinical Trials Highlights – March 2022 (25-03-2022).
- Highlight report en presentaties: Seventh industry stakeholder platform on research and development support (17-03-2022).
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
Health-RI
Nationaal Comité advies dierproevenbeleid (NCad)
NHS Health Research Authority (HRA)
Oekraïne, Rusland, Oorlog
- EU regulators tell sponsors to apply COVID flexibilities to trials impacted by Ukraine war (30-03-2022). Regulatory Focus.
- Fast-track research review for studies affected by the war in Ukraine (25-03-2022). HRA.
Proefschriften
Pharma.be
Science Europe
US Food and Drug Administration (FDA), Verenigde Staten
- Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (februari 2022).
- FDA officials aim to stop misuse of the term ‘digital biomarker’ (29-03-2022). Regulatory Focus.
- Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication (22-03-2022). Advarra.
- Considerations for IRB Review: Artificial Intelligence & Machine Learning (11-03-2022). Advarra.
- Beginner’s Guide to Institutional Review Boards (24-02-2022). Advarra.
Wet openbaarheid van bestuur (Wob)
World Health Organization (WHO), World Health Assembly
ZonMw
- Genderful Research World: om sekse en gender in onderzoek te integreren (28-03-2022).
- Website: Genderful Research World
Overige berichten
- Weekend reads: Plagiarism in biblical scholarship; revelations about publishing ‘lab leak’ preprint; publishing sanctions on Russia (02-04-2022). Retraction Watch.
- For the Common Good: Philosophical Foundations of Research Ethics (2022). Alex John London.
- Regulatory guidelines and preclinical tools to study the biodistribution of RNA therapeutics (mei 2022). Advanced Drug Delivery Reviews.
- Animal-reliance bias in publishing is a potential barrier to scientific progress (27-03-2022). bioRxiv.
- Undisclosed industry payments rampant in drug-trial papers (24-03-2022). Nature.
- Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World. Clin Ther. 2022 Feb 15:S0149-2918(22)00017-0. doi: 10.1016/j.clinthera.2022.01.012.
- Wan Z, Hazel JW, Clayton EW, et al. Sociotechnical safeguards for genomic data privacy. Nat Rev Genet. 2022 Mar 4:1–17. doi: 10.1038/s41576-022-00455-y.