Uitgelicht en gespot op internet (week 46)
Hierbij ontvangt u een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘.
Nieuwstips kunt u insturen via het contactformulier.
Vincent Bontrop
www.bontrop.com
Uitgelicht & Gespot op Internet
All European Academies
Big data
BioCelerate
Cel- en gentherapie, Genome editing, CRISPR-Cas
- ‘Iedereen heeft het recht nieuwe technologie te gebruiken’ (15 november 2019). NEMO Kennislink.
- Onderzoek: Europa op achterstand klinisch onderzoek cel- en gentherapie (12 november 2019). Vereniging Innovatieve Geneesmiddelen.
- Solid Biosciences’ Duchenne gene therapy trial halted after patient suffers serious toxicity (12 november 2019). STAT.
- WHO Commends Russian Response to Proposed Heritable Human Genome Editing (8 november 2019). Regulatory Focus.
- 2039: Nederland zegt ‘nee’ tegen het aanpassen van embryo-DNA (7 november 2019). NEMO Kennislink.
Clinical trials
- The feasibility of web surveys for obtaining patient-reported outcomes from cancer survivors: a randomized experiment comparing survey modes and brochure enclosures (15 november 2019). BMC Medical Research Methodology.
- Apple launches virtual health studies aiming to enroll hundreds of thousands of customers (14 november 2019). STAT.
- Gene Therapy Company Sues FDA After Being Placed on Clinical Hold (11 november 2019). FDA Law Blog, Hyman, Phelps & McNamara PC.
- Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews (11 november 2019). Clinical Trials.
- France to Maintain Fast Track Schemes for Clinical Trials (11 november 2019). Regulatory Focus.
Clinical trial results reporting
- 10-Year Update on Study Results Submitted to ClinicalTrials.gov (14 november 2019). NEJM.
- Uninformed consent (13 november 2019). Medisch Contact.
- Sanctions for not registering and reporting clinical trials: Three red herrings and the way forward (8 november 2019). TranspariMED.
- When politicians talk clinical trials: Nine takeaways from the recent UK parliamentary enquiry (7 november 2019). STAT.
Clinical Trials Transformation Initiative
Compassionate use, Named-patient programs
Data sharing
- In a ‘Wild West’ environment, hospitals differ sharply in what patient data they give Google (15 november 2019). STAT.
- Why NIH is beefing up its data sharing rules after 16 years (11 november 2019). Science.
European Clinical Trial Regulation
- EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Database (14 november 2019). Regulatory Focus.
- EC Offers Further Clarity on Clinical Trial Regulation (12 november 2019). Regulatory Focus.
European Data Protection Board
European Medicines Agency
- EMA Finalizes Clinical Development Guideline for New Gout Treatments (14 november 2019). Regulatory Focus.
- Regulators’ advice can make a difference for faster patient access to highly innovative therapies (12 november 2019).
Global Alliance for Genomics & Health
Good Clinical Practice
Informatiebeveiliging
International Council on Harmonisation
Medische hulpmiddelen
- IMDRF Klinische Evaluatie richtlijnen (12 november 2019). Quality Business Support Blog.
- IMDRF Offers Three Final Clinical Guidelines (11 november 2019). Regulatory Focus.
Recruitment, Diversity, Compensation
- Compensation of subjects for participation in biomedical research in resource – limited settings: a discussion of practices in Malawi (14 november 2019). BMC Medical Ethics.
- Use Commonly Available Data Early to Inform Eligibility and Recruitment, Experts Say (11 november 2019). CenterWatch.
- Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design (9 november 2019). Trials.
- Patient Diversity Campaign. CISCRP.
Trial master file, EDC
- CROs Moving to Electronics, But Paper Still Prevalent, Survey Shows (11 november 2019). CenterWatch.
U.S. Food and Drug Administration
Overig nieuws
- Moving Toward Evidence-Based Policy, The Value of Randomization for Program and Policy Implementation (15 november 2019). JAMA.
- Reviewers asked authors to change their study design. It apparently didn’t go well (15 november 2019). Retraction Watch.
- I (inadvertently) misrepresented others’ research in a way that made my story sound better (14 november 2019). Statistical Modeling, Causal Inference, and Social Science.
- Assessing causal treatment effect estimation when using large observational datasets (14 november 2019). BMC Medical Research Methodology.
- Analysis of official deceased organ donation data casts doubt on the credibility of China’s organ transplant reform (14 november 2019). BMC Medical Ethics.
- The Ban on US Government Funding Research Using Human Fetal Tissues: How Does This Fit with the NIH Mission to Advance Medical Science for the Benefit of the Citizenry? (12 november 2019). Stem Cell Reports.
- Significante investeringen door medicijnsector (12 november 2019). Vereniging Innovatieve Geneesmiddelen.
- Not-So-Golden Years for NIH’s Retired Chimpanzees (7 november 2019). The Hastings Center.
Recent verschenen
- Overzicht bijeenkomsten & consultaties (1 November 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 100 (4 november 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 99 (22 oktober 2019)
Meer nieuws van elders?
- Ga naar news.bontrop.com
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