Uitgelicht en gespot op internet (week 24)

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‘.

Bent u abonnee van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘ en wilt u ook een notificatiebericht ontvangen als er een nieuwe ‘Uitgelicht & Gespot op internet‘ op de website is gepubliceerd? Wijzig vandaag nog uw abonnementsvoorkeuren en vink het wekelijkse supplement ‘Uitgelicht & Gespot op internet‘ aan.

Nog geen abonnee van de Nieuwsbrief voor Goede Onderzoekspraktijken?

---

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

• Stem cell clinics co-opt clinical-trials registry to market unproven therapies, critics say (11 juni 2019). STAT.

Clinical trial results

• Results dissemination from clinical trials conducted at German university medical centres was delayed and incomplete (11 juni 2019). bioRxiv 467746; This article is a preprint and has not been peer-reviewed.

Clinical trial risk and performance management

• Managing Risk Means Measuring the Right Things, Experts Say (10 juni 2019). Center Watch.

Dierexperimenteel onderzoek

• A randomised controlled trial of an Intervention to Improve Compliance with the ARRIVE guidelines (IICARus) (12 juni 2019). Research Integrity and Peer Review 2019 4:12.

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

• On the use of blockchain-based mechanisms to tackle academic misconduct, Research Policy, Volume 48, Issue 9, 2019, 103805.

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

• Ethics of inclusion: Cultivate trust in precision medicine (7 juni 2019). Science, Vol. 364, Issue 6444, pp. 941-942.

Privacy

• Genealogy companies could struggle to keep clients’ data from police (10 juni 2019). Science News.

Risk-based monitoring, Risk assessments

• Performing risk assessments for the risk-based monitoring of clinical trials (13 juni 2019). XLSMetrics.

Vereniging Innovatieve Geneesmiddelen

• Schouw promoot Nederland in Brussel (11 juni 2019).

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)

---

Wilt u ook de Nieuwsbrief voor Goede Onderzoekspraktijken ontvangen?