Uitgelicht en gespot op internet (week 35, 2021)

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.

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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)

• Advies naar aanleiding van de Europese consultatie naar het vergunningverleningsproces van ggo’s bij medische toepassingen (20 augustus 2021).

Covid-19

• Fear of Doing Too Much Too Soon or Too Little Too Late: Research on Covid-19 (20 augustus 2021). Hastings Bioethics Forum.

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)

• Coronavirus: nieuwe versie Belgisch richtsnoer voor het beheer van klinische proeven tijdens de coronaviruspandemie (2 september 2021).
  • Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version v3, d.d. 2 september 2021.

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)

• Update streefbeelden proefdiervrij onderzoek (2 september 2021).

NHS Health Research Authority (HRA)

• Involving pregnant people in health and COVID-19 research: ethics, challenges and solutions – a blog by Michael Pettit (4 augustus 2021).

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.

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Meer actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com

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