Uitgelicht en gespot op internet (week 40, 2022)
Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Advanced Therapy Medicinal Products (ATMPs)
Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG), European Union-U.S. Data Privacy Framework
- FACT SHEET: President Biden Signs Executive Order to Implement the European Union-U.S. Data Privacy Framework (07-10-2022). White House.
- Een kritische beoordeling van de UAVG door het WODC (15-09-2022). Considerati.
BBMRI-ERIC
Beeldvorming met ioniserende straling
Clinical trial monitoring
Clinical trial results reporting
- Improving clinical trial data on registries: lessons from Europe (05-10-2022). TranspariMED.
- Italian regulator under fire for inaction over missing clinical trial results (04-10-2022). TranspariMED.
- Strong progress on trial reporting in Austria and Germany but worsening gaps in Italy – new data (03-10-2022). TranspariMED.
College ter Beoordeling van Geneesmiddelen (CBG)
Decentralized Trials and Research Alliance (DTRA)
Dierexperimenteel onderzoek, Proefdieren
- Universiteiten en umc’s presenteren streefbeeld proefdiervrije innovatie in academisch onderwijs (07-10-2022). UNL
- Dierendag: proeven zonder dieren (04-10-2022). HollandBIO.
- Katja werkt met organoids aan proefdiervrij virusonderzoek (03-10-2022). Proefdiervrij.
- Proefdiervrij de Podcast #6: ‘Muizen eruit, model erin – zo werkt het dus niet.’ Maar hoe werkt het dan wél (30-09-2022). Proefdiervrij.
Dutch Association of Research Quality Assurance (DARQA)
Dutch Clinical Research Foundation (DCRF),Toetsingskader nWMO
European Clinical Research Infrastructrure Network (ECRIN)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Expedited regulatory pathways: A toolbox to provide innovative medicines to patients (05-10-2022).
- Pushing the boundaries of science for the benefit of patients (03-10-2022).
European Medicines Agency (EMA)
- EMA Management Board: highlights of October 2022 meeting (07-10-2022).
- Minutes – DARWIN EU Advisory Board meeting: 6 July 2022 (06-10-2022)
- Call for expression of interest for civil society representatives to participate in the work of EMA’s Paediatric Committee (05-10-2022).
- Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (05-10-2022). EMA.
FAIR
Proefpersonen, Informed consent
- Clicking ‘Accept’ Is Not Informed Consent (07-10-2022). The Hastings Center.
- Five steps every researcher should take to ensure participants are not harmed and are fully heard (04-10-2022). The Conversation.
- Should We Pay Patients In Clinical Trials For Their Time? (29-09-2022). Clinical Leader.
- Is it ethical to be friends with research participants? (29-09-2022). London School of Economics and Political Science.
- Improving the Practice of Obtaining Informed Consent for Biobanking in Clinical Settings (29-09-2022). Biopreservation and Biobanking.
Inspectie Gezondheidszorg en Jeugd (IGJ)
International Council for Harmonisation (ICH)
- ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers (07-10-2022). Regulatory Focus.
- ICH Q14: Pharma groups want clarity on benefits of enhanced approach (04-10-2022). Regulatory Focus.
- ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials – Step5 (06-10-2022). EMA.
- ICH E19 Guideline reaches Step 4 of the ICH Process (04-10-2022).
- E19 EWG: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials.
“The ICH Harmonised Guideline was finalised under Step 4 in September 2022.”
bron: ICH
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Leids Universitair Medisch Centrum (LUMC)
- LUMC zet app in bij grootschalig hartonderzoek (06-10-2022). Skipr.
- Wetenschappers nodigen heel Nederland uit voor onderzoek naar hart- en vaatziekten (06-10-2022).
Ontregel het Onderzoek
Real World Data (RWD)
Research integrity
- Sjoemelen met wetenschappelijk onderzoek gebeurt regelmatig, ontdekte een hoogleraar. Wat valt daaraan te doen? (07-10-2022). De Volkskrant.
- Research Integrity Tools for Journals: Plagiarism detection best practices. Scholastica.
Stichting Code Geneesmiddelen Reclame (CGR)
U.S. Food and Drug Administration (FDA), Verenigde Staten
Wet medisch-wetenschappelijk onderzoek met mensen, Vierde evaluatie WMO
- Universiteit Leiden en LUMC gaan samen met anderen de WMO evalueren (04-10-2022). Universiteit Leiden.
- Erasmus MC en LUMC onderzoeken wet medisch-wetenschappelijk onderzoek (05-10-2022). Skipr.
Wet zeggenschap lichaamsmateriaal (Wzl)
- Brief regering:Nazending bijlage behorende bij de nota naar aanleiding van het verslag inzake Wet zeggenschap lichaamsmateriaal (06-10-2022).
- Bijlage: Overzicht aanvullende werking Wzl
World Health Organization (WHO)
- The fifth edition of the World Health Organization Classification of Tumors of the Central Nervous System: Implications for cancer registries, Neuro-Oncology, 2022;, noac176.
- New WHA resolution on clinical trials (12-09-2022).
- Resolution WHA75.8: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.
“A clinical trial is defined by WHO as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.”
bron: WHO – Joint statement on public disclosure of results from clinical trials, 2017.
ZonMw
Overig
- Weekend reads: Whistleblowers win a victory; a look at COVID-19 retractions; journals as sewage treatment plants (08-10-2022). Retraction Watch.
- Access and quality of biomarker testing for precision oncology in Europe (oktober 2022). European Journal of Cancer.
- The future of medicine in space: drug development, manufacturing, and beyond (06-10-2022). Clinical Trials Arena.
- The next frontiers in cancer vaccines: when academia’s and industry’s bright minds get together (04-10-2022). HollandBIO.
- When failure to correct a flawed paper could put patients’ lives at risk (04-10-2022). Retraction Watch.
- Why We Need More Quality Control in Science Funding… (04-10-2022). The Good Science Project.
- Not so fast with fast funding (03-10-2022). Accountability in Research.
- White House’s open-access research directive scrambles long-entrenched models, raising key questions (03-10-2022). STAT.
- The credibility of science is damaged when universities brag about themselves (30-09-2022). Big Think.
- A framework for sex, gender, and diversity analysis in research (29-09-2022). Science.
- I avoided authorship discussions with collaborators—until I learned some hard lessons (29-09-2022). Science.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties