Ook deze week een overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet.
Vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen. Zo kunt u nog tot en met 9 september reageren op de concept Gedragscode Gezondheidsonderzoek van COREON.
Heeft u zelf iets nieuws gespot dan kunt u dit aan mij kunt melden via het contact formulier.
Algemene verordening gegevensbescherming (AVG), Privacy
- Data privacy laws in the US protect profit but prevent sharing data for public good – people want the opposite (30 augustus 2021). The Conversation.
- Danish DPA: Template Joint Data Responsibility Arrangement in English
Biobanking
- The value of consent for biobanking (23 augustus 2021). Nature Human Behavior.
- Pediatric biobanking and engagement: Join & share practices. BBMRI-ERIC.
Clinical data management, Clinical data sharing
- Effective trial data management even more vital during COVID-19, says study (1 september 2021). Clinical Insider.
- Characteristics of available studies and dissemination of research using major clinical data sharing platforms (18 augustus 2021). Clinical Trials.
- Status, use and impact of sharing individual participant data from clinical trials: a scoping review (18 augustus 2021). BMJ Open.
Clinical trials, Monitoring, Innovative approaches
- CROs must make trial site assessments more efficient says ASCO (1 september 2021). Clinical Insider.
- Clinical trial site remote monitoring may suffice: Updated FDA guidance (31 augustus 2021). Regulatory Focus.
- eConsent Fastest-Growing Type of Remote Technology Used by Sites (30 augustus 2021). WCG CenterWatch.
- Increasing Shift to Virtual Trials Has Reduced Trial Delays and Terminations (30 augustus 2021). WCG CenterWatch.
- Cancer Trials Are More Sluggish and Failure-Prone than Ever, but Industry is Fighting Back (30 augustus 2021). WCG CenterWatch.
- Greater Trial Flexibility Critical to Further Implementation of Innovative Approaches (30 augustus 2021). WCG CenterWatch.
- The Need for a US National Clinical Trial Infrastructure in a Public Health Crisis (26 augustus 2021). JAMA Health Forum.
- Clinical trial strategies for rare neurodevelopmental disorders: challenges and opportunities (17 mei 2021). Nature Reviews Drug Discovery.
- Trial designs using real‐world data: The changing landscape of the regulatory approval process (10 december 2019). Pharmacoepidemiol Drug Saf.
Commissie Genetische Modificatie (COGEM)
Covid-19
EU Clinical Trials Regulation (ECTR), Clinical trials information system (CTIS)
- Updated CTIS online modular training programme
- Module 03 “User access management”
- Module 19) “CTIS for SMEs and academia”
- Clinical trials information system: training and support
- T.b.v. registratie Sponsor Administrator role – https://register.ema.europa.eu/identityiq/home.html
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)
This update is related to remote source data verification (rSDV) options during the COVID-19 pandemic and the possibility of using the e-informed consent process.
Medicines and Healthcare products Regulatory Agency (MHRA)
- MHRA and US FDA tackle challenging data integrity (1 september 2021). Blog MHRA Inspectorate.
- Major milestone reached in the combined review journey (31 augustus 2021). Blog MedRegs.
- Combined review to facilitate speedier set up for clinical research trials (15 juli 2021).
Nationaal Comité advies dierproevenbeleid (NCad)
NHS Health Research Authority (HRA)
U.S. Food and Drug Administration (FDA)
- Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH), Final (31 augustus 2021).
- Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Rev. Final (30 augustus 2021).
Overige
- Weekend reads: A deep dive into a problematic study of ivermectin; how journals respond to allegations; prison and now scrutiny (4 september 2021). Retraction Watch.
- ‘De echte waarde zit in informatie’ (1 september 2021). Vereniging Innovatieve Geneesmiddelen.
- Social media mining in drug development—fundamentals and use cases (1 september 2021). Drug Discovery Today.
- Drowning in the literature? These smart software tools can help (1 september 2021). Nature.
- When Researchers Sound the Alarm on Problematic Papers (1 september 2021). The Scientist.
- What’s next for lab-grown human embryos? (31 augustus 2021). Nature.
- Which criteria are used in the investigations of alleged cases of research misconduct? (28 augustus 2021). Accountability in Research.
- Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial (28 augustus 2021). Stem Cells Translational Medicine.
- Nieuwe wet na schandalen in Frans anatomisch centrum (25 augustus 2021). NOS.
- How to Publish at Pandemic Speed (23 augustus 2021). BioScience.
Meer actueel nieuws, bijeenkomsten en publieke consultaties