Uitgelicht en gespot op internet (week 14, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Ook de ‘Events‘-pagina en de ‘Consultations‘-pagina zijn bijgewerkt en er zijn weer nieuwe RSS-feeds toegevoegd aan de nieuwsfeed op news.bontrop.com.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Therapeutische vaccins voortaan beoordeeld door METC’s (08-04-2022).
- CCMO presenteert jaarverslag 2021 (04-04-2022).
Clinical research, Clinical trials, Clinical trial results reporting
- Benchmarking Protocol Deviations and Their Variation by Major Disease Categories (04-04-2022). Therapeutic Innovation & Regulatory Science.
- As Trial Diversity Efforts Still Struggle, Increasing Inclusivity Requires Multi-Pronged Action (04-04-2022). WCG CenterWatch.
- African clinical trial denied access to key COVID drug Paxlovid (04-04-2022). Nature.
- Risk Based Management in Clinical Trials: Regulators Focus on What Matters Most! (04-04-2022). Fiona Maini, via LinkedIn.
- Should the control arms of randomized trials have an expiry date? (01-04-2022). Nature Reviews Clinical Oncology.
- Where are the Clinical Study Reports we were promised? (31-03-2022). TranspariMED.
- Strategic, feasibility, economic, and cultural aspects of Phase 0 approaches. Clin Transl Sci. 2022 Mar 12. doi: 10.1111/cts.13269.
- Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance (30-01-2022). Therapeutic Innovation & Regulatory Science.
Commissie Regelgeving Onderzoek (COREON)
Data access, Data sharing
- EDPB adopts statement on the new Trans-Atlantic Data Privacy Framework, letter concerning independence of Belgian SA & discusses membership Spring Conference (07-04-2022). EDPB.
- ‘Registratie aan de bron moet door!’ (07-04-2022). Registratie aan de bron.
- Independent report: Better, broader, safer: using health data for research and analysis (07-04-2022). Department of Health and Social Care (Verenigd Koninkrijk).
- TEHDAS scrutinises data access processes in four countries (06-04-2022). TEHDAS.
- In pursuit of data immortality (04-04-2022). Nature.
- To (privacy) shield or not to shield (27-03-2022). Life Sciences & Privacy Blog.
European Clinical Research Infrastructure Network (ECRIN)
- EU-AMRI launched in Brussels (06-04-2022).
- Clinical trial success relies on effective patient recruitment – International Clinical Trials Day 2022 (04-04-2022).
European Medicines Agency (EMA), Clinical Trial Information System (CTIS), Inspections, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP)
- Verschillende CTIS Training Programme modules zijn bijgewerkt, waaronder:
- Sponsors’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (bijgewerkt 08-04-2022).
- Member states’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (bijgewerkt 08-04-2022).
- FAQs: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (bijgewerkt 08-04-2022).
- Guidance for applicants/MAHs involved in GMP and GCP inspections coordinated by EMA (06-04-2022).
- IRIS guide for applicants – (How to create and submit scientific applications, for industry and individual applicants (versie 2.7, bijgewerkt 05-04-2022).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
League of European Research Universities (LERU)
Norecopa, Dierexperimenteel onderzoek
Oekraïne, Rusland, Oorlog
- CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials. HMA, Clinical Trials Coordination Group.
- EU to help sponsors and CROs mitigate disruption caused by Putin’s war (06-04-2022). Clinical Insider.
- EMA Advises Using COVID-19 Approaches to Support Ukrainian Clinical Trials (04-04-2022). WCG CenterWatch.
Predatory journals
Proefpersonen, Inclusie, Consent, Inclusiviteit, Representativiteit
- Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press.
- ‘We need to be much more diverse’: More than half of data used in health care AI comes from the U.S. and China (06-04-2022). STAT.
- Addressing racial and phenotypic bias in human neuroscience methods (05-04-2022). Nature Neuroscience.
- ‘De eerste keer dat je zo’n pil slikt denk je: god, waar ben ik eigenlijk mee bezig?’. Proefpersonen: Waarom doen duizenden gezonde Nederlanders elk jaar mee aan medicijnonderzoek? „Ik ga natuurlijk niet liegen en zeggen dat ik de vergoeding niet fijn vind.” (28-03-2022). NRC.
- “It All Depends”: Patient and Decision Partner Experiences in Cancer Clinical Trial Decision-Making (27-03-2022). Qualitative Health Research.
US Food and Drug Administration (FDA)
- Newly added guidance documents
- Draft – Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers (07-04-2022).
- Draft – M7(R2) Addendum: Application of the principles of the ICH M7 Guideline to calculation of compound-specific acceptable intakes(06-04-2022).
- Final – Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (06-04-2022).
- FDA Officials Look to Set the Record Straight on Definition of ‘Digital Biomarker’ (04-04-2022). WCG CenterWatch.
- Sites, Sponsors Should Carefully Negotiate Who’s on the Hook for Patient Injuries (04-04-2022). WCG CenterWatch.
US Health and Human Services (HHS), Office of Research Integrity (ORI)
Overige berichten
- Weekend reads: Should open access advocates vilify publishers?; authorship for sale, $5,000; is economics just ‘bafflegab?’ (09-04-2022). Retraction Watch.
- Tien adviezen voor het maken van impact: ‘Welke lastige dilemma’s komen daarbij kijken?’ (10-04-2022). Universiteit Leiden.
- Journals acknowledge that a critical “reader” has a name: Elisabeth Bik (08-04-2022). Retraction Watch.
- Methodological conduct of prognostic prediction models developed using machine learning in oncology: a systematic review (08-04-2022). BMC Medical Research Methodology.
- Geen enkele universiteit heeft registratie bijbanen hoogleraren op orde (06-04-2022). Niewsuur.
- Academic favoritism at work: insider bias in Turkish national journals (05-04-2022). Scientometrics.
- Concussion researcher claims AFL hindered two-year research project into players’ health (05-04-2022). The Guardian.
- The medical algorithmic audit (05-04-2022). The Lancet Digital Health.
- Who will oversee the ethical limits of human embryo research? (31-03-2022). Nature Biotechnology.
- RBQM in Its Prime: Companies Realize Lasting Benefits When Adopting Risk-Based Approaches (16-03-2022). Brian Barnes, via LinkedIn.