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‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
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Clinical trials
- Effective stakeholder engagement: design and implementation of a clinical trial (SWOG S1415CD) to improve cancer care (11 juni 2019). BMC Medical Research Methodology 2019 19:119.
- Broaden Criteria to Maximize Trial Results, FDA Says (10 juni 2019). CenterWatch.
- Are Virtual and Remote Clinical Trials Dead? (30 mei 2019). Jacob LaPorte, via LinkedIn.
- Clinical trials take a long time to get started. Here’s how to speed it up (28 maart 2019). STAT.
Clinical trials registry
Clinical trial results
Clinical trial risk and performance management
Dierexperimenteel onderzoek
European Commission
- List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with article 57(2) of Regulation (EC) no 726/2004 and its implementing guideline 2008/c168/021 Version 2.0 (3 juni 2019).
- List of fields to be made public from EudraCT for paediatric clinical trials in accordance with article 41 of Regulation (EC) no 1901/2006 and its implementing guideline 2009/c28/01 Version 2.0 (3 juni 2019).
Gene editing, CRISPR, Gene therapy
- ‘It felt like an ’80s criminal drama’: What happened when a biohacker met bureaucrats investigating him (14 juni 2019). STAT.
- Russian biologist plans more CRISPR-edited babies (10 juni 2019). Nature.
Good Manucfacturing Practice (GMP), Mutual recognition agreement EU-US
- The Netherlands and Luxembourg to also benefit from EU-US mutual recognition agreement for inspections (11 juni 2019). European Commission.
- Two additional countries to benefit from EU-US mutual recognition agreement for inspections (11 juni 2019). European Medicines Agency.
HMA Clinical Trials Facilitation and Coordination Group
- List of participating member states in VHP, 2019 (juni 2019).
- Results of the Voluntary Harmonisation Procedure 2009 – 2018, V.02 (juni 2019).
Integriteit, Academic misconduct
mHealth, Health apps
- The Limits of Empowerment: How to Reframe the Role of mHealth Tools in the Healthcare Ecosystem (6 juni 2019). Sci Eng Ethics (2019).
- Hoe weet je of health apps betrouwbaar zijn? (27 mei 2019). Rathenau Instituut.
Precision medicine
Privacy
Risk-based monitoring, Risk assessments
Vereniging Innovatieve Geneesmiddelen
Overig nieuws
- CBG-MEB. Regulatory Science, Edition 8 June 4th, 2019.
- Drug Discovery Today, Volume 24, Issue 6, Pages 1229-1320, June 2019.
- Ethics in Scientific Research: An Examination of Ethical Principles and Emerging Topics. Santa Monica, CA: RAND Corporation, 2019.
- The impact of varying cluster size in cross-sectional stepped-wedge cluster randomised trials (14 juni 2019). BMC Medical Research Methodology 2019 19:123.
- China announces hefty fines for unauthorized collection of DNA (14 juni 2019). Nature.
- Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use (14 juni 2019). BMC Medical Research Methodology 2019 19:124.
- Who should decide about children’s and adolescents’ participation in health research? The views of children and adults in rural Kenya (14 juni 2019). BMC Medical Ethics 2019 20:41.
- FDA says HCMC doctors kept ketamine study going after pledging to stop (14 juni 2019). StarTribune.
- Data science tools and applications on the way to Pharma 4.0 (14 juni 2019). Drug Discovery Today, 2019.
- The association between quality measures of medical university press releases and their corresponding news stories—Important information missing. PLOS ONE 14(6): e0217295.
- FDA and BioCelerate Join Forces on Nonclinical Research (13 juni 2019). Regulatory Focus.
- Genes for Good: Engaging the Public in Genetics Research via Social Media (13 juni 2019). American Journal of Human Genetics.
- Senators Seek Details on Sharing US Genomic Data With Companies Linked to China’s Government (13 juni 2019). Regulatory Focus.
- Trial management: we need a cadre of high-class triallists to deliver the answers that patients need (13 juni 2019). Trials 2019 20:354.
- Mention of ethical review and informed consent in the reports of research undertaken during the armed conflict in Darfur (2004–2012): a systematic review (13 juni 2019). BMC Medical Ethics 2019 20:40.
- House votes to overturn Trump administration ban on fetal tissue research (13 juni 2019). STAT.
- Fecal Transplant Is Linked to a Patient’s Death, the F.D.A. Warns (13 juni 2019). The New York Times.
- Peer review is not just quality control, it is part of the social infrastructure of research (12 juni 2019). LSE Impact Blog.
- Lego-powered biomedical research (12 juni 2019). Medical Research Council.
- How Parkinson’s UK is piloting the Patient Engagement Quality Guidance (11 juni 2019). Patient Focused Medicines Development.
- To Save The Science Poster, Researchers Want To Kill It And Start Over (11 juni 2019). NPR.
- Population health intervention research: the place of theories (11 juni 2019). Trials 2019 20:285.
- Facilitating validation of prediction models: a comparison of manual and semi-automated validation using registry-based data of breast cancer patients in the Netherlands (8 juni 2019). BMC Medical Research Methodology 2019 19:117.
- Towards inclusive priority-setting for global health research projects: recommendations for sharing power with communities (5 juni 2019). Health Policy and Planning, czz041.
- Publish or the Population Perishes: The Challenges of Regional Publishing in Public Health (29 mei 2019). Asia Pacific Journal of Public Health.
- Using Instrumental Variables to Address Bias From Unobserved Confounders. JAMA. Published online May 02, 2019 321(21):2124–2125. doi:10.1001/jama.2019.5646
Recent verschenen
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 93 (2 juni 2019)
- Supplement ‘Overzicht bijeenkomsten & consultaties’ (1 juni 2019)
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