Uitgelicht en gespot op internet (week 20)

Uitgelicht

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Biobanking,

• Consent and Autonomy in the Genomics Era (2 mei 2019). Curr Genet Med Rep (2019).

Clinical trials

• 543 nieuwe aanvragen ingediend voor de lancering van klinische studies in België in 2018 (18 mei 2019). Pharma.be.
• Baseline testing in cluster randomised controlled trials: should this be done? (17 mei 2019). BMC Medical Research Methodology 2019 19:106.
• Will Virtual Trials Mean The End Of CROs? (16 mei 2019). Clinical Leader.
• Are non-constant rates and non-proportional treatment effects accounted for in the design and analysis of randomised controlled trials? A review of current practice (16 mei 2019). BMC Medical Research Methodology 2019 19:103.
• Correcting for misclassification and selection effects in estimating net survival in clinical trials (16 mei 2019). BMC Medical Research Methodology 2019 19:104.
• Spotlight Commentary: How to prove pharmacology of immunomodulatory drugs in a phase 1 trial? (25 april 2019). British Journal of Clinical Pharmacology.

Data sharing

• Data sharing and how it can benefit your scientific career (13 mei 2019). Nature.

Dutch Clinical Research Foundation

• DCRF Patiëntengroep. “We komen er aan!”

Embryo editing, Genetische modificatie

• Webinar: The race to deliver CRISPR (14 mei 2019). STAT.
• China set to introduce gene-editing regulation following CRISPR-baby furore (20 mei 2019). Nature.
• Realigning gene editing with clinical research ethics: What the “CRISPR Twins” debacle means for Chinese and international research ethics governance (17 mei 2019). Accountability in Research, DOI: 10.1080/08989621.2019.1617138
• Australië: gene-editing niet onder GM-wetgeving (14 mei 2019). HollandBIO.
• German ethics council expresses openness to eventual embryo editing (13 mei 2019). STAT.
• Are we ready to genetically modify a human embryo? Or is it too late to ask?, Accountability in Research.
• A novel governance framework for GMO (23 april 2019). EMBO reports (2019) e47812.

European Chemical Industry Council, Active Pharmaceutical Ingredient Committee

• APIC. Practical risk-based guide for managing Data Integrity Revision 2, April 2022.

GDPR, Persoonsgegevens, Privacy

• Security Breaches Getting Harder to Spot, Expert Says  (20 mei 2019). Center Watch.
• Waarom een norm voor veilig mailen?. NEN.
• UCSD has not told women with HIV of data breach, despite researchers’ pleas (14 mei 2019). Inewsource.
• The interplay between the GDPR and the EU Clinical Trials Regulation (13 mei 2019). Pharmafile.
• Women’s views about contraception requirements for biomedical research participation. PLOS ONE 14(5): e0216332.

Gegevensbeschermingsautoriteit

• Impact van de Brexit op de doorgifte van persoonsgegevens.

Real world evidence

• Brave New Real World: FDA Draft Guidance Takes First Steps to Move RWE from Dystopia (14 mei 2019). Hyman, Phelps & McNamara, FDA Law Blog.

Risk-based monitoring

• Risk-Based Monitoring Should Be Best Practice, ACRO Tells FDA (20 mei 2019). Center Watch.
• Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance (15 mei 2019) Regulatory Focus.

Overig nieuws

• Push for drug pricing transparency strikes a nerve with industry (19 mei 2019). Swissinfo.ch.
• Clinical Trials Fuel Local Economies (17 mei 2019). ACRP.
• An analysis of current practices in undertaking literature reviews in nursing: findings from a focused mapping review and synthesis (16 mei 2019). BMC Medical Research Methodology 2019 19:105.
• FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May (16 mei 2019). Regulatory Focus.
• Norm voor veilig mailen in de zorg gepubliceerd (15 mei 2019). Skipr.
• A new study sparks a war of words over the drug industry’s commitment to research (14 mei 2019). STAT.
• REED: P-Values: Come, Let Us Reason Together (14 mei 2019). The Replication Network.
• Schaalvergroting voor European Lead Factory (14 mei 2019). Vereniging Innovatieve Geneesmiddelen.
• Early in vitro testing for adverse effects on embryos (14 mei 2019). Science Daily.
• Postpublication Metrics of Randomized Clinical Trials With and Without Null Findings. JAMA. 2019;321(18):1825–1826. doi:10.1001/jama.2019.2994
• Revisiting the decay of scientific email addresses (13 mei 2019). bioRxiv 633255. This article is a preprint and has not been peer-reviewed.
• Relationships, Not Money, Key to Avoiding Conflict of Interest (13 mei 2019). Center Watch.
• Just how common is positive publication bias? Here’s one researcher who’s trying to figure that out (13 mei 2019). Retraction Watch.
• Pilot “Parallelle Procedures CBG-ZIN” van start: innovatieve geneesmiddelen sneller bij de patiënt (13 mei 2019). HollandBIO.
• Body of evidence and approaches applied in the clinical development program of fixed‐dose combinations in the European Union from 2010‐2016 (11 mei 2019). British Journal of Clinical Pharmacology.
• Schouw juicht proef parallelle procedures toe (10 mei 2019). Vereniging Innovatieve Geneesmiddelen.
• Gezond investeringsklimaat noodzakelijk voor medicijnontwikkeling (10 mei 2019). Vereniging Innovatieve Geneesmiddelen.
• Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials. JAMA Intern Med. 2019;179(5):642–647. doi:10.1001/jamainternmed.2018.8351
• Data analytics in healthcare not focused on insight, Goldacre argues (26 maart 2019). Digital Health.
• Questionable Industry-Sponsored Postneonatal Pediatric Studies in Slovenia, Current Therapeutic Research, 2019, ISSN 0011-393X.

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