Uitgelicht en gespot op internet (week 26)
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘. Heeft u een nieuwstip voor het volgende overzicht? Stuur uw tip in via het contactformulier.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Uitgelicht & Gespot op Internet
ALLEA (All European Academies)
Biohacking, Genetic Enhancement Technologies
- How biohackers are trying to upgrade their brains, their bodies — and human nature (25 juni 2019). Vox.
- How Should We Regulate Genetic Enhancement Technologies? (20 juni 2019). Practical Ethics.
Brexit, GLP
Clinical Trials Registry
Clinical Trials Results Reporting
Clinical Trials Transformation Initiative
Dierexperimenteel onderzoek
European Commission
- Pharmaceuticals: Germany becomes the 27th Member State to benefit from the EU-US mutual recognition agreement for inspections (27 juni 2019).
- One additional country to benefit from EU-US mutual recognition agreement for inspections (27 juni 2019). EMA.
Flanders.bio
Gene editing
- Alarmed by new ‘CRISPR babies’ plan, top science figures say they’re powerless to stop it (24 juni 2019). STAT.
- Do we have a right to an unmanipulated genome? The human genome as the common heritage of mankind (20 juni 2019). Bioethics.
HollandBIO
Integrity
Medicines and Healthcare products Regulatory Agency
Oncode instituut
Onderzoek sildenafil, Zwangeren, Foetus
- ‘Patiëntveiligheid was geen moment in het geding bij AMC-onderzoek’ (22 juni 2019). Het Parool.
- ‘Onderzoekers AMC negeerden belangrijke wetenschappelijke gegevens’ (12 juni 2019). Het Parool.
U.S. Food and Drug Administration, Guidance
- Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry (28 juni 2019)
- Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry (27 juni 2019)
- Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff (26 juni 2019)
Patient involvement, Participant experience
- EU must prioritise patient engagement in health research (26 juni 2019). Patient Focused Medicines Development.
- Incorporating Patient Preferences in Noninferiority Trials. JAMA. Published online June 24, 2019.
- Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials (24 juni 2019). Trials 2019 20:381.
- Effective involvement: a report on the evaluation of a research awareness training package for public involvement in health research (13 juni 2019). Research Involvement and Engagement 2019 5:21.
Pharma.be
Vereniging Innovatieve Geneesmiddelen
- Klinisch onderzoek in Nederland: kansen en uitdagingen (24 juni 2019).
- De ACRON bij Nieuwspoort event (25 juni 2019). ACRON.
Overig nieuws
- Scoping implementation science for the beginner: locating yourself on the “subway line” of translational research (28 juni 2019). BMC Medical Research Methodology 2019 19:133.
- Once ‘bodies for hire,’ CROs are finding a new role as data specialists (28 juni 2019). BioPharma Dive.
- Digital is bringing the change clinical trials need, DIA head says (28 juni 2019). BioPharma Dive.
- Potential effects of increased openness in pharma: the original knowledge behind new drugs (26 juni 2019). Drug Discovery Today.
- Embryo experiments take ‘baby steps’ toward growing human organs in livestock (26 juni 2019). Science.
- FDA officials see ‘missed opportunity’ with patient outcomes in clinical trials (26 juni 2019). BioPharma Dive.
- Startling China organ claims raise alarm about transplant research (25 juni 2019). Nature.
- Journal Publishes Concern About Study Using Forced Organ Donation (25 juni 2019). Medscape.
- Improve Trials with Integrated Electronic Systems Instead of Information Silos, Survey Says (24 juni 2019). CenterWatch.
- Is sexual desire a medical issue? An experimental drug for women revives an intense debate (20 juni 2019). STAT.
- Ethical considerations for new HIV prevention trials (17 juni 2019). The Lancet HIV.
- A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines. J Clin Epidemiol. 2019 Jun 15. pii: S0895-4356(19)30344-0. doi: 10.1016/j.jclinepi.2019.06.007. [Epub ahead of print].
- Ballantyne A, Eriksson S. Special issue: Research ethics revised. The new CIOMS guidelines and the World Medical Association Declaration of Helsinki in context. [Editorial]. Bioethics 33 (3), 309-405.
- The Challenge And Promise Of Pediatric Device Innovation (5 juni 2019). Med Device Online.
Recent verschenen
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