Uitgelicht en gespot op internet (week 7 & 8, 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 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‘.
Algemene verordening gegevensbescherming (AVG)
- Model DPIA Rijksdienst 2.0; what’s new? (20-02-2022). IB&P.
- Limits on Data Subjects’ Right to Be Informed in Health Research: The Case of France (16-02-2022). Rosario Murga Ruiz, via LinkedIn.
- GA4GH GDPR Brief: What constitutes an ‘international data transfer?’ Recent developments by the EDPB and implications for genomic and health data sharing (14-02-2022).
Biobanking
Clinical research, Clinical trials
- Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials (april 2022). Contemporary Clinical Trials.
- Application of machine learning methods in clinical trials for precision medicine (april 2022). JAMIA Open.
- Sponsor, Site Priorities Don’t Match Up, More Alignment Needed in 2022 (14-02-2022). WCG CenterWatch.
- Clinical Research ‘Remarkably Resilient’ During Pandemic (14-02-2022). WCG CenterWatch.
- Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis. JAMA Oncol. Published online February 03, 2022.
- Noninferiority Margins in Clinical Trials—A Moving Target? JAMA Cardiol. Published online February 02, 2022.
- Consequences of Inaccurate Assumptions in Coronary Stent Noninferiority Trials: A Systematic Review and Meta-analysis. JAMA Cardiol. Published online February 02, 2022.
- Reporting bias in clinical trials: Progress toward transparency and next steps. PLoS Med. 2022 Jan 19;19(1):e1003894.
Clinical Trials Regulation (EU CTR)
- PIC/S revises GMP guide to reflect EU Clinical Trials Regulation (17-02-2022). ECA Academy.
- How to handle Expiry Dates under the CTR (17-02-2022). ECA Academy.
Commissie Regelgeving Onderzoek (COREON)
Committee on Publication Ethics (COPE)
Cybersecurity, Clinical Trial Agreements
Data access, Data sharing
- Democratizing data at Novartis through clinical trial data access (25-02-2022). Drug Discovery Today.
- SDV focust zich op afsprakenstelsel kwaliteitsregistraties (februari 2022). Samenwerkende Data Verwerkers.
- NIH issues a seismic mandate: share data publicly (16-02-2022). Nature.
Dierexperimenteel onderzoek
Dutch Oncology Research Platform (DORP)
- Terugblik op eerste werkconferentie Cohorten (23-02-2022).
- Verzekerde zorg in klinische studies wel of niet vergoed: impact op financiering (14-02-2022).
Embryowet
Wordt verwacht:
- Brief met de voorgenomen wijzigingen van de Embryowet – Derde kwartaal 2022
- Indiening van het wetsvoorstel tot wijziging van de Embryowet – Tweede kwartaal 2023
Enrollment, Inclusiviteit, Diversiteit, Representativiteit
- Improving diversity in Alzheimer’s research can help update the ‘gold standard’ for all medical research (25-02-2022). STAT.
- Terugkijken: Virtual Seminar Series: Kadija Ferryman, PhD – “Race Matters in Health Data” (23-02-2022). Berman Institute, via YouTube.
- PIs Need to Take a Look at Their Recruitment Mindset, Survey Shows (21-02-2022). WCG CenterWatch.
- Patiëntenorganisatie door EUPATI fellow steviger aan het roer bij medicijnontwikkeling (16-02-2022). EUPATI.
- Comparison of Racial, Ethnic, and Geographic Location Diversity of Participants Enrolled in Clinic-Based vs 2 Remote COVID-19 Clinical Trials. JAMA Netw Open. 2022;5(2):e2148325.
- Most autism intervention studies lack data on race, ethnicity (14-02-2022). Spectrum.
- Developing theory-based text messages to support retention in clinical trials: A mixed methods approach (31-01-2022). Research Methods in Medicine & Health Sciences.
European Clinical Research Alliance on Infectious Diseases (Ecraid)
- ECRAID-Base Launches European Clinical Research Alliance (24-02-2022). UMC Utrecht.
- Ecraid begins its fight against infectious diseases (16-02-2022). ECRIN.
- UMC Utrecht neemt voortouw in nieuw Europees instituut infectiebestrijding (18-02-2022). Skipr.
European Medicines Agency (EMA), Good Clinical Practice (GCP)
- Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated 24-02-2022).
- CTIS newsflash – 18 February 2022
- Principal documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP (updated 18-02-2022).
- Big Data highlights – Issue 1 (15-02-2022).
Europese Commissie
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) – België
- Het FAGG moedigt non-profitorganisaties en de academische wereld aan om een aanvraag in te dienen voor het pilootproject rond de herbestemming van vergunde geneesmiddelen (25-02-2022).
- Uitzondering voor opdrachtgevers van niet-commerciële klinische proeven voor de aanpassing van de verpakking/etikettering van een geneesmiddel voor onderzoek dat in de handel is (21-02-2022). FAGG (België).
Medicines and Healthcare products Regulatory Agency (MHRA) – Verenigigd Koninkrijk
- Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward (18-02-2022).
- Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned (14-02-2022).
- MHRA Good Practice Symposia Week (7 to 11 March 2022).
Medische hulpmiddelen
- More on placing on the market (18-02-2022). Medicaldeviceslegal.
- Their Bionic Eyes Are Now Obsolete and Unsupported (15-02-2022). IEEE Spectrum.
National Survey on Research Integrity
Nieuwsbrief voor Goede Onderzoekspraktijken
Organisation for Economic Co-operation and Development (OECD)
Publications, Research output
Research ethics
TransCelerate BioPharma Inc.
- Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View (2021).
- Common Templates for Nonclinical Studies (updated, versie 1.1).
Universiteiten van Nederland
U.S. Food and Drug Administration (FDA)
- Ask the Experts: Seeking IRB Approval for Medical Device Studies (21-02-2022). WCG CenterWatch.
- FDA releases 43 new and revised product-specific guidances (17-02-2022). Regulatory Focus.
- CDER Issues Guidance Agenda for 2022 Featuring Clinical Trials (14-02-2022). WCG CenterWatch.
Overige berichten
- Weekend reads: ‘Published crap;’ randomized grant awards; ‘Problems in Science Publishing’ (26-02-2022). Retraction Watch.
- Weekend reads: Paying for publication?; deeper looks at citation practices; preprints and retractions (19-02-2022). Retraction Watch.
- How to protect the first ‘CRISPR babies’ prompts ethical debate (25-02-2022). Nature.
- PLOS Publication Ethics: A frank discussion on handling difficult cases (22-02-2022).
- Small molecules and their impact in drug discovery: A perspective on the occasion of the 125th anniversary of the Bayer Chemical Research Laboratory (21-02-2022). Drug Discovery Today.
- Analysis of 567,758 randomized controlled trials published over 30 years reveals trends in phrases used to discuss results that do not reach statistical significance (18-02-2022). PLoS Biology.
- Confrontatie met dubieuze onderzoekspraktijken doet promovendi sneller afhaken (16-02-2022). ScienceGuide.
- Arkansas jail’s ivermectin experiments recall historical medical abuse of imprisoned minorities (14-02-2022). The Guardian.
- The reproducibility debate is an opportunity, not a crisis (10-02-2022). BMC Research Notes.
- Time to make rare disease diagnosis accessible to all (07-02-2022). Nature Medicine.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties