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.
- 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
Brexit
Computerized System Validation
European Medicines Agency
- Questions and answers on Data Monitoring Committees issues (8 oktober 2020).
- 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
Handbook of Experimental Pharmacology
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
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.