Uitgelicht en gespot op internet (week 42, 2020)

Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:

BBMRI-ERIC

• Webinar terugkijken: Ethical handling of incidental findings in research (8 juni 2020). Via YouTube.

Bescherming persoonsgegevens

• EDPB Adopts Guidelines on Relevant and Reasoned Objection under Article 60 of the GDPR (15 oktober 2020). LexBlog.
• What’s New in the EDPB’s Draft Guidelines on Controllers and Processors Under the GDPR? (Part 1) (12 oktober 2020). LexBlog.
• What’s New in the EDPB’s Draft Guidelines on Controllers and Processors Under the GDPR? (Part 2) (15 oktober 2020). LexBlog.
• EDPB Addresses Data Exchange With International Organizations Under GDPR (12 oktober 2020). LexBlog.
• New Guidelines for Companies from German Supervisory Authority (DPA-BW) following Schrems II (12 oktober 2020). LexBlog.
• What the CJEU Missed in Schrems II: American Agencies Respond (9 oktober 2020). LexBlog.
• Analyzing the EDPB’s Guidelines on Article 28 Data Processing Agreements (5 oktober 2020). LexBlog.
• Draft EU guidelines on the concepts of controller and processor—key elements for life sciences companies (14 september 2020). BioSlice Blog, Arnold & Porter.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Engelse vertaling nieuwe model proefpersoneninformatie beschikbaar (16 oktober 2020).

European Medicines Agency (EMA)

• The EMA plans to grant early access to a test version of the CTIS (2 oktober 2020). Hogan Lovells.

Good Clinical Practice (GCP)

• Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice (24 september 2020). Clinical Trials Transformation Initiative.

Koninklijke Nederlandse Akademie van Wetenschappen (KNAW)

• KNAW pleit voor doorlopend eigen werkkapitaal – rolling grants – voor wetenschappers (16 oktober 2020).

Research protocols

• Recording Now Available: CTTI’s New Robust Set of Resources to Assist with Designing and Running Master Protocols (13 oktober 2020). Clinical Trials Transformation Initiative.
  • Project: Master Protocol Studies
• The GetReal Trial Tool

The GetReal Trial Tool offers you step by step guidance to evaluate the options and implications of introducing real world elements in clinical trial design. The tool is open access. It can be used without entering any real trial information.

Bron: The GetReal Trial Tool website.

Ministerie van Volksgezondheid, Welzijn en Sport

• Adviespanel Innovatieve Behandelingen COVID19 (14 oktober 2020).

Nederlandse Vereniging voor Farmaceutische Geneeskunde (NVFG)

• NVFG Jaarcongres 1 oktober 2020 terugkijken (via YouTube).

Organisation for Economic Co-operation and Development (OECD)

• OECD Policy Responses to Coronavirus (COVID-19): Greater harmonisation of clinical trial regulations would help the fight against COVID-19 (4 augustus 2020).

Recruitment, Representativiteit, Engagement

• Andrew George: Consent is only possible in a relationship (14 oktober 2020). BMJ Opinion.
• Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift (12 oktober 2020).
• We Must Use This Moment to Improve Diversity in Clinical Trials — And Not Just for Vaccines (9 oktober 2020). TIME.
• ‘I Won’t Be Used as a Guinea Pig for White People’ (7 oktober 2020). The New York Times.
• Short guide on patient partnerships in rare diseases research projects (juli 2020). European Joint Programme Rare Diseases.

Overig nieuws

• Unleashing the full potential of life sciences and biotechnology in Europe (15 oktober 2020). The Parliament.
• Covid-19 clinical trial pauses ‘show the system is working’ (14 oktober 2020). STAT.
• Millions of animals may be missing from scientific studies (14 oktober 2020). Science.
• Continued post-retraction citation of a fraudulent clinical trial report, 11 years after it was retracted for falsifying data (14 oktober 2020). Scientometrics.
• Researchers face disciplinary action as dozens of their studies fall under scrutiny (12 oktober 2020). Retraction Watch.
• The Sad (and Saddening) History of Makena (6 oktober 2020). Science Translational Medicine.
• CTTI Paper Features Tool to Help Sponsors and Patient Groups Identify Mutually Beneficial Opportunities for Collaboration (30 september 2020). Clinical Trials Transformation Initiative.
• How the FDA should protect its integrity from politics (9 september 2020). Nature.
• Coronavirus reinfections: three questions scientists are asking (4 september 2020). Nature.
• The New Normal in Clinical Trials: Decentralized Studies (31 augustus 2020). Annals of Neurology.