Uitgelicht en gespot op internet (week 41, 2020)

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

Artificial Intelligence

• Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension (9 september 2020). BMJ 2020; 370 :m3164.
  • CONSORT-AI sets standards for reporting on artificial intelligence in trials (25 september 2020). Regulatory Focus.
• Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension (9 september 2020). BMJ 2020; 370 :m3210.
• The SPIRIT-AI and CONSORT-AI Working Group website.

Biobanking

• Biobanks as Essential Tools for Translational Research: The Belgian Landscape (2020). Lausanne: Frontiers Media SA. doi: 10.3389/978-2-88966-016-2

Brexit

• How will Brexit affect clinical trial registration and reporting in the UK?. TranspariMED.

Computerized System Validation

• Computerized System Validation in Clinical Research 101: an insightful webinar based on our own validation experience (19 mei 2020). GCP Central.

European Medicines Agency

• Questions and answers on Data Monitoring Committees issues (8 oktober 2020).
  • EMA offers new Q&A on data monitoring committees (8 oktober 2020). Regulatory Focus.
• Highlights of Management Board: October 2020 meeting (5 oktober 2020).
• EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines (5 oktober 2020).
• Reply to the European Ombudsman’s letter concerning transparency and independence of the work of the European Medicines Agency in supporting the development and evaluation of COVID-19 medicines (29 september 2020).

Gentherapie, GGO, GMO

• VIG: Meer nodig om Nederland koploper biotech te maken (6 oktober 2020). Vereniging Innovatieve Geneesmiddelen.

Handbook of Experimental Pharmacology

• Good Research Practice in Non-Clinical Pharmacology and Biomedicine (2020).

Persoonsgegevens

• GA4GH GDPR Brief: Joint data controllership in the genomics context (5 oktober 2020). Global Alliance for Genomics & Health.
• Status Update Code of Conduct: Teaming up & Talking about it (2 oktober 2020). BBMRI-ERIC, via YouTube.
• Flowchart: choose the correct legal basis in the GDPR (versie 2). Jeroen Terstegge, via LinkedIn.
• Data-Subject Rights under GDPR v.2.0 (23 september 2020). Rosario Murga Ruiz, via LinkedIn.

Recruitment, Representativiteit, Engagement

• Threats of Bots and Other Bad Actors to Data Quality Following Research Participant Recruitment Through Social Media: Cross-Sectional Questionnaire (7 oktober 2020). Journal of Medical Internet Research.
• He’s a recruiter for a Covid-19 vaccine trial. Can he overcome communities’ distrust — and his own mother’s? (7 oktober 2020). STAT.
• Exclusive: Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown (6 oktober 2020). Reuters.
• The forgotten, the ignored and the under-served – trials cannot continue to fail large parts of society (1 oktober 2020). BMC.
• Non-randomised evaluations of strategies to increase participant retention in randomised controlled trials: a systematic review (29 september 2020). Systematic Reviews.
• Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development (29 september 2020). Therapeutic Innovation & Regulatory Science.

Trial management

• Life Sciences Professionals Believe COVID-19 Must Change Trial Management (30 september 2020). Applied Clinical Trials.

Overig nieuws

• Frauds in scientific research and how to possibly overcome them (6 oktober 2020). Journal of Medical Ethics.
• As AstraZeneca’s Covid-19 vaccine trial remains on hold in U.S., participants waiting on a second dose are in limbo (6 oktober 2020). STAT.
• FDA Enforcement of Clinical Trial Violations Declining Under Trump (5 oktober 2020). WCG CenterWatch.
• Trend of Longer Trial Timelines is Likely to Continue (5 oktober 2020). WCG CenterWatch.
• What does COVID-19 vaccine efficacy mean? (4 oktober 2020). Science News.
• Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective (29 september 2020). Nature reviews drug discovery.
• COVID-19 Study Register: Cochrane’s curated collection for global researchers passes more than 20,000 references…and counting! (29 september 2020). Cochrane.
• EU to create new biomedical research agency modelled on BARDA (17 september 2020).Science | Business.