Hierbij een nieuw overzicht van actualiteiten en nieuwsberichten de de afgelopen week zijn gespot op het internet.
Vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen.
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Algemene verordening gegevensbescherming, Data doorgifte, SCC
Biobanken, Wet zeggenschap lichaamsmateriaal
- Wet zeggenschap lichaamsmateriaal
Brexit
Clinical trials
- Informed consent in cluster randomised trials: a guide for the perplexed (27 september 2021). BMJ Open.
- Healthy Volunteers in First in Human Oncology Drug Development for Small Molecules (23 september 2021). British Journal of Clinical Pharmacology.
- Amplifying Patient Voices in Protocol Design (8 september 2021). Applied Clinical Trials.
Clinical trial results reporting
Data integrity
Dierexperimenteel onderzoek
- EMA implements new measures to minimise animal testing during medicines development (29 september 2021). EMA.
- EMA announces new efforts to minimize animal testing (1 oktober 2021). Regulatory Focus.
- Treatment of laboratory animals changed, but humans remained in charge. “Animal testing still revolves around human health” (20 september 2021). Universiteit Utrecht.
ECTR, CTIS
- CTIS Training Programme
Embryo-onderzoek
EU In Vitro Diagnostics Regulation (IVDR)
European Medicines Agency (EMA)
- Call for expressions of interest for civil society representatives to participate in work of Committee for Advanced Therapies (24 september 2021).
- PRAC & Management Board: Call for expressions of interest for civil society representatives to participate in work of EMA (22 september 2021).
- European Medicines Agency’s Privacy Statement For the clinical data publication website (27 september 2021).
Good Clinical Practice (GCP)
Health-RI
Inclusie, Involvement, Recruitment, Representatieve steekproef
- Paying participants isn’t the way to improve clinical trial recruitment (28 september 2021). STAT.
- Effectiveness and Ethics of Incentives for Research Participation 2 Randomized Clinical Trials (20 september 2021). JAMA Internal Medicine.
- Fair payment and just benefits to enhance diversity in clinical research (14 juli 2021). Journal of Clinical and Translational Science.
- Research Equity and Enrolling Non-English Speakers (27 september 2021). Advarra.
- A teenager on TikTok disrupted thousands of scientific studies with a single video (24 september 2021). The Verge.
- Facilitating the inclusion of adults with intellectual disability as direct respondents in research: Strategies for fostering trust, respect, accessibility and engagement (24 september 2021). Journal of Applied Research in Intellectual Disabilities.
- Introducing patient and public involvement practices to healthcare research in Austria: strategies to promote change at multiple levels (9 augustus 2021). BMJ Open.
- Considerations for Cardiovascular Genetic and Genomic Research With Marginalized Racial and Ethnic Groups and Indigenous Peoples: A Scientific Statement From the American Heart Association (26 juli 2021). Circulation: Genomic and Precision Medicine.
Master protocols, Umbrella protocols, Basket/Bucket protocols, Platform protocols
- Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials. Ther Innov Regul Sci. 2021 Jun 23.
- The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review (juli 2020). Clinical Therapeutics.
- Master protocols: New directions in drug discovery (juni 2020). Contemporary Clinical Trials Communications.
- Reporting of master protocols towards a standardized approach: A systematic review (september 2019). Contemporary Clinical Trials Communications.
- Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols (18 september 2019). Trials.
- Umbrella and basket trials in oncology: ethical challenges (23 augustus 2019). BMC Medical Ethics.
- Master protocols in clinical trials: a universal Swiss Army knife? (juni 2021). The Lancet Oncology.
- “FDA Modernizes Clinical Trials with Master Protocols” February 26, 2019 Issue (26 februari 2019). U.S. Food and Drug Administration.
- Draft guidance: Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics (Oktober 2018). U.S. Food and Drug Administration.
- Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both (6 juli 2017). NEJM.
- Efficiencies of platform clinical trials: A vision of the future (17 februari 2016). Clinical Trials.
- The Master Protocol Concept (oktober 2015). Seminars in Oncology.
- CTTI: Master protocol studies
Medicines and Healthcare products Regulatory Agency (MHRA)
- Guidance on GxP data integrity (updated 27 september 2021). Medicines and Healthcare products Regulatory Agency.
Added new information titled ‘Good Laboratory Practice (GLP)’ - Updated data integrity requirements for GLP Monitoring Programme members (27 september 2021).
Placebo
Publications, Preprints
Training, Educatie
- Introduction to the Principles and Practice of Clinical Research (IPPCR). National Institutes of Health. (gratis cursus)
U.S. Food and Drug Administration
- Draft guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices (29 september 2021).
- Draft guidance: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (28 september 2021).
- Draft guidance: Benefit-Risk Assessment for New Drug and Biological Products (september 2021).
- CHAPTER 48 – Bioresearch Monitoring. Sponsors and Contract Research Organizations (15 september 2021).
- Getting Through Inspections: Seasoned Research Institution Details Successful Strategies (27 september 2021). WCG CenterWatch.
Overige
- Weekend reads: Paper mill sanctions; UT Austin suspends prof, repays grant funds; researchers in Mexico threatened with arrest (2 oktober 2021). Retraction Watch.
- Meer inzicht in belasting bijwerkingen biologicals (30 september 2021). Skipr.
- Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies (28 september 2021). Drug Discovery Today.
Meer actueel nieuws, bijeenkomsten en publieke consultaties