Uitgelicht en gespot op internet (week 23, 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.
Er zijn ook weer een aantal nieuwe publicaties consultaties, bijeenkomsten en boeken toegevoegd aan de ‘Consultations‘-overzichtspagina (consultations.bontrop.com), de ‘Events‘ overzichtspagina (events.bontrop.com) en de Boekenplank!
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Cancer
- A turning point in cancer (11-06-2022). Ground Truths.
- A Cancer Trial’s Unexpected Result: Remission in Every Patient (05-06-2022). The New York Times.
- PD-1 Blockade in Mismatch Repair–Deficient, Locally Advanced Rectal Cancer (05-06-2022). NEJM.
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical research, Clinical trials, Clinical trial results reporting
- ASCO rectal cancer trial result draw publicity but what is the impact? (10-06-2022). Clinical Trials Arena.
- Tighter European trial regulations likely due to Covid-19 research waste (10-06-2022). Clinical Trials Arena.
- How Oncology Clinical Trials Can Use Data to Dig Deeper on Diversity (09-06-2022). Clinical Trials Arena.
- Non-Alcoholic Steatohepatitis (NASH) accounts for 6.3% share of global Gastrointestinal clinical trial activity in 2021 (09-06-2022). Clinical Trials Arena.
- Optimizing Patient Recruitment and Engagement Strategies (09-06-2022). Applied Clinical Trials.
- Cavazzoni: Pandemic-era tools, learnings are here to stay (07-06-2022). Regulatory Focus.
- Regulatory Considerations for Digitally Driven Trials (07-06-2022). Applied Clinical Trials.
- Quantifying Protocol Deviation Experience by Clinical Phase (07-06-2022). Applied Clinical Trials.
- No need to redact clinical trial data, medical journals tell regulators (06-06-2022). TranspariMED.
- Many Black cancer patients say they aren’t offered the chance at clinical trials, survey finds (06-06-2022). STAT.
- Clinical Trials in Ukraine During the War (01-06-2022). Applied Clinical Trials.
- Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register (16-02-2022). Clinical Trials.
Clinical Trials Regulation (CTR)
CT-College (College Klinische Proeven), Federale Overheidsdienst (FOD) Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu (België)
- Advies voor Belgische EC’s aangaande het beoordelen van veiligheidsrapporten in CTR-dossiers (03-06-2022).
- Advice for Belgian ECs regarding the assessment of safety reports in CTR applications (03-06-2022).
Conflicts of Interest (COI)
Data sharing, Data transfer, Data reuse, European Health Data Space (EHDS)
- OECD, Recommendation of the Council concerning Guidelines Governing the Protection of Privacy and Transborder Flows of Personal Data, OECD/LEGAL/0188
- EZK, OCW, VWS en Health-RI slaan de handen ineen voor structureel beter hergebruik van gezondheidsdata (07-06-2022). Health RI.
- Democratizing data at Novartis through clinical trial data access (juni 2022). Drug Discovery Today.
- Data Sharing and Reanalyses Among Randomized Clinical Trials Published in Surgical Journals Before and After Adoption of a Data Availability and Reproducibility Policy. JAMA Netw Open. 2022;5(6):e2215209.
- Dental Research Data Availability and Quality According to the FAIR Principles (02-06-2022). Journal of Dental Research.
- Many researchers were not compliant with their published data sharing statement: mixed-methods study (29-05-2022). Journal of Clinical Epidemiology.
European Health Data Space (EHDS), Towards the European Health Data Space (TEHDAS)
- TEHDAS consults stakeholders on their expectations for safe use of health data (08-06-2022).
- BNC fiche: European Health Data Space (07-06-2022). Health-RI.
- Data reuse obstacles removal traject. Health-RI.
- Presentaties beschikbaar van: Workshop Data quality framework for medicines regulation (07-04-2022). EMA.
Diversity
European Clinical Research Infrastructure Network (ECRIN)
- Launch of 2022 Data Centre Certification Call (09-06-2022).
- Questionnaire to inform a European multinational clinical project proposal training (08-06-2022).
- Funding available for ECRIN services through ISIDORe TNA Open Call (07-06-2022).
Grant applications
Kunstmatige Intelligentie (KI)
- New report on the impact of artificial intelligence on the doctor-patient relationship (07-06-2022). Council of Europe.
- The impact of artificial intelligence on the doctor-patient relationship
- Understanding healthcare workers’ confidence in AI -Report 1 of 2 (May 2022). NHS AI Lab & Health Education England.
Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), Medical Device Coordination Group (MDCG)
- Euro Roundup: EFPIA warns of ‘critical challenges’ to starting clinical trials that use IVDs (09-06-2022). Regulatory Focus.
- Het vaststellen van de state-of-the-art van een medische hulpmiddelen (06-06-2022). Quality Business Support Blog.
- MDCG guidance as pseudo-legislation (05-06-2022). Medicaldeviceslegal.
Nieuwsbrief voor Goede Onderzoekspraktijken
- Nieuwsflits van 9 juni 2022 – Handreiking elektronische toestemmingsverlening gepubliceerd.
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 149 (03-06-2022).
NIH Pragmatic Trials Collaboratory
Oncode Institute
Research ethics, Research integrity, Publication ethics
- Research and publication ethics knowledge and practices in the health and life sciences: Findings from an exploratory survey (augustus 2022). Ethics, Medicine and Public Health.
- Research integrity training ‘a box-ticking exercise’ (09-06-2022). Times Higher Education.
- Citatie-applicaties bedreigen de wetenschappelijke praktijk (09-06-2022). ScienceGuide.
- This app helps researchers explore ethical dilemmas (08-06-2022). Nature.
- Controversial supplements researcher not guilty of misconduct, Canadian university concludes (01-06-2022). Science.
- The integrity of the research record: a mess so big and so deep and so tall (25-05-2022). British Journal of Psychiatry.
Society for Clinical Data Management (SCDM)
Stichting Code Geneesmiddelenreclame (CGR)
U.S. Food and Drug Administration (FDA), Verenigde Staten
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products (09-06-2022).
- Human Gene Therapy Products Incorporating Human Genome Editing (09-06-2022).
- Study: FDA approves new oncology drugs quicker than EMA (10-06-2022). Regulatory Focus.
- Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests (09-06-2022). Regulatory Focus.
- FDA’s New Diversity Plan Guidance, And What It Means for Sponsors Developing Cancer Drugs (09-06-2022). Applied Clinical Trials.
ZonMw
- Een technologie ‘lenen’ om jouw onderzoek uit te voeren? (30-05-2022).
- Een technologie ‘lenen’ voor je onderzoek? Het unieke subsidie-instrument van Enabling Technologies Hotels (ETH): een terugblik met partner DTL.
Overige berichten
- Weekend reads: ‘Foul play’ among protective scholars; how to increase rigor; science and a ‘culture of misinformation’ (11-06-2022). Retraction Watch.
- African researchers lead campaign for equity in global collaborations (10-06-2022). Nature.
- Innovation Facts: DNA, deCODE en geneesmiddelen (07-06-2022). Vereniging Innovatieve Geneesmiddelen.
- Minister Kuipers matigt monopoliepositie rond medicinale cannabis (07-06-2022). HollandBIO.
- ‘Zich kwetsbaar opstellen is net een kerneigenschap van goede wetenschap en van haar authentieke beoefenaars’ (06-06-2022). Knack.
- Funders: The missing link in equitable global health research? PLOS Glob Public Health 2(6):e0000583.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties