Uitgelicht en gespot op internet (week 23)
Ook deze week een nieuwe ‘Uitgelicht en gespot op internet‘.
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‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
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Academy of Medical Sciences
Biobanking, Precision medicine
- Ethics of inclusion: Cultivate trust in precision medicine (7 juni 2019). Science.
- Cleveland Biobank Increasing Participation, Gaining Trust Of African-Americans (31 mei 2019). Ideastream.
- Toolbox voor implementatie van de Code Goed Gebruik Lichaamsmateriaal (29 mei 2019). ZonMw.
Clinical trials
- Synthesizing existing evidence to design future trials: survey of methodologists from European institutions (7 juni 2019). Trials 2019 20:334.
- A systematic review of feasibility studies promoting the use of mobile technologies in clinical research (6 juni 2019). npj Digital Medicine 2, Article number: 47 (2019).
- Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions (6 juni 2019). Trials 2019 20:329.
- Relaxed eligibility criteria would double patient numbers in lung cancer studies: ASCO (4 juni 2019). Outsourcing-Pharma.com.
Clinical trials research subject registry
Clinical Trials Transformation Initiative
- CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research (6 juni 2019).
- CTTI Webinar Highlights the Importance & Benefits of Quality by Design (20 mei 2019).
Dierexperimenteel onderzoek
Gene editing, CRISPR, Fetal tissue research
- Trump administration halts fetal-tissue research by government scientists (5 juni 2019). Nature.
- The Trump administration will end fetal tissue research by government scientists (5 juni 2019). STAT.
- Update: House spending panel restores U.S. ban on gene-edited babies (4 juni 2019). Science.
- Congress revives ban on altering the DNA of human embryos used for pregnancies (4 juni 2019). STAT.
- He Jiankui tried to protect ‘CRISPR babies’ against HIV. But his attempted fix shortens lives, study shows (3 juni 2019). STAT.
- Gene edits to ‘CRISPR babies’ might have shortened their life expectancy (3 juni 2019). Nature.
GDPR
- GA4GH GDPR Brief: How is Article 89 implemented across theEU/EEA? (3 juie 2019). Global Alliance for Genomics and Health.
- Het verwerkingsregister van de Autoriteit Persoonsgegevens: wat kunnen we ervan leren? (3 juni 2019). AuditConnect.
Medicines and Healthcare products Regulatory Agency
Medische hulpmiddelen
- Medical Device Regulations – the clinical claim (7 juni 2019), Tobias Schreiegg via LinkedIn.
- The Challenge And Promise Of Pediatric Device Innovation (5 juni 2019). Med Device Online.
National Institute for Health Research
- Research Participant Experience Survey 2018/19, May 2019 (version 4.0).
- Launch of new research costing tool for life sciences industry (13 mei 2019).
Non-interventional, Ethical approval
Patient Engagement
- Reflections on the Evolution of Patient Engagement in Drug Development. Pharm Med (2019) 33: 179.
- Fed up with Washington, ALS advocates consider ACT UP’s take-no-prisoners approach (7 juni 2019). STAT.
- EU researchers to have access to ‘pool’ of patient experts (3 juni 2019). Patient Focused Medicines Development.
Publishing
- Graylists for academic publishing (7 juni 2019). Neurodojo.
- New preprint server for medical research BMJ 2019; 365 :l230
- How to bring preprints to the charged field of medicine (6 juni 2019). Nature.
- PRESS RELEASE: Researchers Respond to Revised Guidance for Plan S (5 juni 2019). Eurodoc.
Reproducibility
- Reproducibility trial publishes two conclusions for one paper (4 juni 2019). Nature.
- Knowledge and attitudes among life scientists towards reproducibility within journal articles (4 juni 2019). bioRxiv 581033; This article is a preprint and has not been peer-reviewed.
Research integrity, Research misconduct
- “Our current approaches are not working:” Time to make misconduct investigation reports public, says integrity expert (4 juni 2019). Retraction Watch.
- Make reports of research misconduct public (3 juni 2019). Nature.
- Research integrity is much more than misconduct (3 juni 2019). Nature.
- The Embassy of Good Science website
U.S. Food and Drug Administration
- FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials (5 juni 2019). BioPharma Dive.
- FDA ‘open for business’ in considering real-world evidence, Sharpless says (5 juni 2019). BioPharma Dive.
- FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials (3 juni 2019). Hogan Lovells.
- FDA Guidance
- Guidance document: Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (6 June 2019)
- Guidance document: Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry (6 June 2019)
- FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations (6 juni 2019). Regulatory Focus.
- CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis (6 juni 2019). Regulatory Focus.
Wageningen University & Research
Overig nieuws
- Nature Reviews Drug Discovery contents June 2019 Volume 18 Number 6.
Journal of Clinical Research Best Practices, June 2019. - Impact of organ-on-a-chip technology on pharmaceutical R&D costs (8 juni 2019). Drug Discovery Today.
- Individual brain organoids reproducibly form cell diversity of the human cerebral cortex (5 juni 2019). Nature.
- Three randomized controlled trials evaluating the impact of “spin” in health news stories reporting studies of pharmacologic treatments on patients’/caregivers’ interpretation of treatment benefit ( 4 juni 2019). BMC Medicine 2019 17:105.
- Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world? (4 juni 2019). The Washington Post.
- Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration. JAMA Intern Med. Published online June 03, 2019.
- Correlates of time to approval and other clinical development periods (3 juni 2019). Drug Discovery Today.
- A survey in Mexico about ethics dumping in clinical research (3 juni 2019). BMC Medical Ethics 2019 20:38.
- Immuuntherapie tegen kanker slaat aan, maar er is meer geld nodig voor onderzoek(1 juni 2019). Trouw.
- Open Peer Commentaries. Let Us Not Take the Ethics Out of Innovative Practice: A Case Against Institutional Review (28 mei 2019). The American Journal of Bioethics.
Ook interessant
- Opinie: Door bureaucratie en privacy stagneert de wetenschap (27 mei 2019). Medisch Contact.
- Medisch-wetenschappelijk onderzoek in spoedeisende situaties (30 april 2019). Ned Tijdschr Geneeskd. 2019;163:D3857.
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?