Uitgelicht en gespot op internet (week 21)
Hierbij een nieuw overzicht van nieuwsberichten en andere publicaties die ik afgelopen week via e-mail, RSS-feeds of andere bronnen heb mogen ontvangen.
Heeft u een nieuwstip voor het overzicht? Stuur mij uw tip via het contactformulier.
Biobanking and Biomolecular Resources Research Infrastructure (BBMRI-NL)
Clinical trials
- Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned (24 mei 2019). Trials 2019 20:284.
- Navigating trial enrollment roadblocks for underrepresented populations (22 mei 2019). Outsourcing-Pharma.com.
- The true cost of white-washed research (22 mei 2019). Raconteur.
- Barriers to Cancer Clinical Trial Enrollment (17 mei 2019). Cancer Therapy Advisor.
- Addressing guideline and policy changes during pragmatic clinical trials (14 mei 2019). Clinical Trials.
- Fase 1-studies vragen om veel uitleg aan de patiënt (7 mei 2019). Antoni van Leeuwenhoek.
Clinical trial results reporting
- Clinical trial transparency on the line at the World Health Assembly (20 mei 2019). All Trials.
- Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey (7 mei 2019). Annals of Internal Medicine.
Dierexperimenteel onderzoek
- Norecopa newsletter, 3-2019 (25 May).
- Are Animal Experiments Justified? (9 mei 2019). Nautilus.
- Revised recommendations for health monitoring of non-human primate colonies (2018): FELASA Working Group Report(8 mei 2019). Laboratory Animals.
- Examining compliance with ethical standards for animal research: is there a need for refinement? A qualitative study from northern Europe (1 mei 2019). Laboratory Animals.
- Opinion: AI Beats Animal Testing at Finding Toxic Chemicals (1 mei 2019). The Scientist.
- Recommendations for design and conduct of preclinical in vivo studies of orthopedic device‐related infection (22 januari 2019). Journal of Orthopaedic Research.
ELSI Servicedesk
European Data Protection Board
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Gentherapie, GGO, Genome Editing, Cell therapy
- New International Commission Launched on Clinical Use of Heritable Human Genome Editing (22 mei 2019). U.S. National Academies of Sciences, Engineering, and Medicine.
- Steeds meer gen- en celtherapieën in ontwikkeling (22 mei 2019). Skipr.
- Scientists Modify Viruses With CRISPR To Create New Weapon Against Superbugs (22 mei 2019). NPR.
- ‘Maak Nederland snel klaar voor kansen gentherapie’ (21 mei 2019). Vereniging Innovatieve Geneesmiddelen.
- China set to introduce gene-editing regulation following CRISPR-baby furore (20 mei 2019). Nature.
- How bans on germline editing deprive patients with mitochondrial disease (20 mei 2019). Nature Biotechnology (2019).
- A justice‐based argument for including sickle cell disease in CRISPR/Cas9 clinical research (20 mei 2019). Bioethics.
- Endpoints News – Cancer research groups urge FDA to overhaul standards for early cell therapy trials, cutting time and cost. But will “pre-competitive” alliances fly? (20 mei 2019). Friends of Cancer Research.
- Whitepaper ‘Designing the Future of Cellular Therapies’ (17 mei 2019). Friends of Cancer Research.
Medicines and Healthcare products Regulatory Agency
- GCP Serious Breaches – the 2018 Edition (24 mei 2019). Blog MHRA Inspectorate.
- GCP Stakeholder Engagement Meeting (StEM), minutes and presentations from the May 2019 Stakeholder Engagement meeting.
Medical devices, IVD, Technology, Innovation
- Owning Ethical Innovation: Claims about Commercial Wearable Brain Technologies (22 mei 2019). Neuron, Volume 102, Issue 4, 22 May 2019, Pages 728-731.
- Digital health: a path to validation (13 mei 2019). npj Digital Medicine, volume 2, Article number: 38 (2019).
- National MDR and IVDR implementation news – Netherlands implementation decree consultation (12 mei 2019). Medical devices legal.
- IVDR, in-house developed tests and the state of MDR/IVDR implementation (12 mei 2019). Medical devices legal.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- Press Release May 2019
- TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings (22 mei 2019). Regulatory Focus.
Promotie
- The Ethics and Governance of Health Research Infrastructure, Universiteit Utrecht.
TransCelerate
Vereniging Innovatieve Geneesmiddelen
Overig nieuws
- Success factors of crowdfunding campaigns in medical research: perceptions and reality (24 mei 2019). Drug Discovery Today.
- Kaisa Immonen: Industry links with patient organisations—transparency is fundamental (24 mei 2019). The BMJ Opinion.
- Timing of first-in-child trials of FDA-approved oncology drugs. European Journal of Cancer , Volume 112 , 49 – 56.
- Children wait six and half years longer than adults for new cancer drugs, study says (22 mei 2019). Pharmafile.
- Meer duidelijkheid nodig over vertegenwoordiging in de zorg (21 mei 2019). Gezondheidsraad.
- Four of the world’s largest drug companies are teaming with Verily. Here is what they get (21 mei 2019). STAT.
- Oprichting Invest-NL stap dichterbij (21 mei 2019). HollandBIO.
- Artificial Intelligence in Health Care: Will the Value Match the Hype? JAMA. Published online May 20, 2019. doi:10.1001/jama.2019.4914
- Overheid, een investering in farmacie zou twee vliegen in een klap slaan (15 mei 2019). De Volkskrant.
- Scientific discovery in a model-centric framework: Reproducibility, innovation, and epistemic diversity. PLoS ONE 14(5): e0216125.
- Brazilian biomedical science faces reproducibility test (9 mei 2019). Nature.
- Bioethics in the Oversight of Clinical Research: Institutional Review Boards and Data and Safety Monitoring Boards. Kennedy Institute of Ethics Journal 29(1), 33-49. Johns Hopkins University Press. Retrieved May 26, 2019, from Project MUSE database.
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