Uitgelicht en gespot op internet (week 46, 2020)

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

Clinical Trials Transformation Initiative

• Recording Now Available: CTTI Releases New Resources for Adoption of a Quality by Design Approach (13 november 2020).
• New CTTI Project Aims to Improve Clinical Evidence with Practical Approaches for Embedding Trials Into Health Care Settings (27 oktober 2020).

COVID-19

• Pfizer says placebo patients will eventually get its Covid-19 vaccine. The question of when is complicated (12 november 2020). STAT.
• Incident zorgt voor maand vertraging coronavaccin Janssen (12 november 2020). Skipr.

• Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19 (11 november 2020). Medicines and Healthcare products Regulatory Agency.
• Building resilience into clinical trial design and conduct during the pandemic (11 november 2020). Blog MHRA Inspectorate.
• How to spot good Covid-19 vaccine trials results when you see them (10 november 2020). STAT.
• The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race (10 november 2020). STAT.
• Met opzet besmet voor onderzoek (9 november 2020). NTvG.
• Risico’s bij besmettingsstudies zijn nu nog te groot (4 november 2020). NRC.
• Nuffield Council on Bioethics responds to announcement of UK human challenge trials (20 oktober 2020).
• Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19 (16 oktober 2020). BMJ.
• Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov (oktober 2020). JAMA Internal Medicine.
• Managing uncertainty: Regulatory reporting in multinational trials during COVID-19 (13 juli 2020). Regulatory Focus.

eClinical Forum

• Investigator Site eSource-Readiness Assessment (versie 2020.2, juli 2020). (eSRA Handbook).

European & Developing Countries Clinical Trials Partnership  (EDCTP)

• EDCTP Knowledge Hub.

EU-US Privacy Shield, Shrems II

• European Data Protection Board (EDPB)
  • Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data (10 november 2020).
  • EDPB Publishes Draft Recommendations on Supplementary Measures for Data Transfers (12 november 2020). LexBlog.
  • EDPB adopts recommendations on international data transfers following Schrems II decision (12 november 2020). LexBlog.
  • EDPB Adopts Recommendations on Supplementary Measures for Data Transfers Following Schrems II Decision (12 november 2020). LexBlog.
  • Aanbevelingen EDPB voor doorgifte persoonsgegevens naar derde landen (13 november 2020). ICT Recht.
• European Commission
  • Commission Implementing Decision on standard contractual clauses for the transfer of personal data to third countries
  • First impressions: New EU Standard Contractual Clauses – the Good, the Bad, and the Ugly (13 november 2020). Phil Lee, via LinkedIn.
• European data export bonanza: revised SCCs and EDPB Schrems II guidance published (13 november 2020). LexBlog.
• Dataexport in beweging: aanbevelingen voor doorgifte data na Schrems II (EDPB) én publicatie nieuwe modelcontractbepalingen (EC) (13 november 2020). Dirkzwager.
• Data Transfers Post Schrems-II: Draft EDPB Recommendations and New SCCs Now Available (13 november 2020). TrustArc.

Global Alliance for Genomics and Health

• GA4GH GDPR Brief: The Concept of Personal Data in the GDPR (10 november 2020).

Monitoring, remote source data verification

• Euro Roundup: Swissmedic allows remote source data verification (12 november 2020). Regulatory Focus.

Transcelerate

• The Pulse on Progress: TransCelerate Shares Third Quarter Highlights (11 november 2020).

US Food and Drug Administration (FDA)

• Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (November 2020).
  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development (9 november 2020).
  • FDA lays out strategies for promoting diversity in clinical trial enrollment (9 november 2020). Regulatory Focus.
• FDA offers strategies to streamline schizophrenia drug trials (11 november 2020). Regulatory Focus.

ZonMw

• Terugkijken: Translationeel Onderzoek: ATMP’s  Replay (26 oktober 2020).

Overige berichten

• De ondoorzichtige wereld achter de corona-wattenstaaf (13 novembr 2020). NOS.
• Censored patients in Kaplan–Meier plots of cancer drugs: An empirical analysis of data sharing (december 2020). European Journal of Cancer.
• Public attitudes toward an authorization for contact program for clinical research (5 november 2020). Journal of the American Medical Informatics Association.
• First do no harm: An exploration of researchers’ ethics of conduct in Big Data behavioral studies (5 november 2020). PLoS ONE.
• Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial (november 2020). Drug Discovery Today.
• Research fraud: a long-term problem exacerbated by the clamour for research grants (28 oktober 2020). Quality in Higher Education.
• Why is uploading clinical trial results onto trial registries so important? (24 april 2019).

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