Uitgelicht en gespot op internet (week 44)

Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

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Uitgelicht & Gespot op Internet

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Algemene verordening gegevensbescherming

• Kamerbrief over aanpassingen UAVG en evaluatie AVG (31 oktober 2019). Ministerie van Justitie en Veiligheid.
• Researchers spotlight the lie of ‘anonymous’ data (24 juli 2019). Techcrunch.
• Normuitleg grondslag ‘gerechtvaardigd belang’. Autoriteit Persoonsgegevens.

Brexit

• Brexit: stand van zaken. Ministerie van Buitenlandse Zaken.
• Beware the UK government’s Brexit promises (29 oktober 2019). Nature.
• (Br)exit? (29 oktober 2019). ACRON.
• Kamerbrief over Stand van zaken Brexit voorbereidingen in de zorg (28 oktober 2019). Ministerie van Volksgezondheid, Welzijn en Sport.

Clinical Trial Results Reporting

• Most clinical trials run by small companies are missing results (1 november 2019). TranspariMED.
• Who Has the Right to See Clinical Trial Data? (30 oktober 2019). Applied Clinical Trials.
• Registratieplicht klinische trials massaal ontdoken (30 oktober 2019). Medisch Contact.
  • Dutch universities violate clinical trial transparency rules on a large scale (31 oktober 2019). TranspariMED.
• European Medicines Agency pledges to make clinical trial reporting easier for universities (29 oktober 2019). TranspariMED.

Clinical Trials, Research ethics, History

• Novartis Admits to ‘Mistake’ After Partial Clinical Hold Placed on Zolgensma Trial (31 oktober 2019). Regulatory Focus.
• Novartis admits to ‘mistake’ after partial clinical hold placed on Zolgensma trial (31 oktober 2019). Endpoints News.
• The Swedish cavity experiments: How dentists rotted the teeth of the mentally handicapped to study candy’s effect (30 oktober 2019). CNN Health.
• On the troubling trail of psychiatry’s pseudopatients stunt (29 oktober 2019). Nature.
• 8 Mysteries About Remote Clinical Trials Revealed (29 oktober 2019). Maya Zlatanova, via LinkedIn.
• Ethical research — the long and bumpy road from shirked to shared (29 oktober 2019). Nature.
• Post-term pregnancy research cancelled after six babies die (28 oktober 2019). The Guardian.
• Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance., PLoS Med. 2019 Sep 6; 16(9):e1002915. doi: 10.1371/journal.pmed.1002915. eCollection 2019 Sep.

Frailty

• New harmonized considerations on the evaluation instruments for baseline characterisation of frailty in the European Union., Br J Clin Pharmacol. 2019 Jul 5. doi: 10.1111/bcp.14044.

Medische dossiers en faillissementen

• Overdracht medische dossiers Slotervaart in voorbereiding (30 oktober 2019). Medische Contact.

Medische hulpmiddelen

• An overview of medical device governance in the UK  (Juni 2019). HealthWatch.
  • Will Europe’s incoming Medical Device Regulation improve evidence standards and transparency? (1 november 2019). TranspariMED.
• Counting down to the MDR date of application, and the legal stuff to get right before May 2020 (29 oktober 2019). Medicaldeviceslegal.
• MDR/IVDR Guidance: MDCG Explains What’s Coming (25 oktober 2019). Regulatory Focus.
• Ongoing Guidance development within MDCG Subgroups (bijgewerkt 25 oktober 2019).
• MDCG endorsed documents European Commission.

Nederlandse Federatie van Universitair Medische Centra

• Nieuwe NFU eBROK® cursus! (25 oktober 2019).
  • Website NFU eBROK

Patient involvement, Participation, Inclusie, Representatief onderzoek, Retention

• Nature Reviews Drug Discovery, Volume 18 Issue 11, November 2019.
• Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial (1 november 2019). Trials.
• Current drugs are “poisoning” elderly patients due to insufficient trial data, House of Lords committee hears (1 november 2019). Pharmafile.
• Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel (30 oktober 2019). Trials.
• Authority and the Future of Consent in Population-Level Biomedical Research (30 oktober 2019). Public Health Ethics.
• ‘Betrokkenheid en werving patiënten klinisch onderzoek moet beter’ (29 oktober 2019). Vereniging Innovatieve Geneesmiddelen.
• Reducing research waste by promoting informed responses to invitations to participate in clinical trials (28 oktober 2019). Trials.
• Giving Patients Back Their Voice in Clinical Trials (28 oktober 2019). CenterWatch.
• Integrating patient reported outcomes into clinical trials (21 oktober 2019). PM Live.
• Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: Results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), Aging Clin Exp Res (2019).
• Engaging patients in medicines regulation: a tale of two agencies., Nature Reviews Drug Discovery, ISSN 1474-1784 (online).

Pediatrisch onderzoek, Juvenile Idiopathic Arthritis

• Informed Consent for Paediatric Clinical Trials in Europe 2015 (bijgewerkt 23 oktober 2019). (European Network of Paediatric Research, EMA.
• Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop., J Rheumatol. 2019 Aug;46(8):1006-1013. doi: 10.3899/jrheum.181088. Epub 2019 Feb 15.

Quality Management

• Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight. ACRO.

Real world data

• Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency (28 oktober 2019). CTTI.

Training en educatie

• European survey on national training activities in clinical research (28 oktober 2019). Trials.
• A review of quantitative analytical training needs for users of longitudinal studies (Oktober 2019). CLOSER.
  • A review of quantitative analytical training needs for users of longitudinal studies Executive summary. CLOSER.

U.S. Food and Drug Administration

• Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts (29 oktober 2019).

Weesgeneesmiddelen, Rare diseases

• Utrecht University develops knowledge agenda on rare diseases (21 oktober 2019) Universiteit Utrecht.
  • Universiteit Utrecht ontwikkelt kennisagenda zeldzame ziekten (29 oktober 2019). Vereniging Innovatieve Geneesmiddelen.
• Bijwerkingen vaak pas bekend na markttoelating (6 september 2019). Pharmaceutisch Weekblad.

Wet medisch-wetenschappelijk onderzoek met mensen

• Publieke consultatie: Wijziging wet medisch wetenschappelijk onderzoek met mensen (1 november 2019). Overheid.nl.

World Medical Association

• WMA Issues Revised Guidelines on Genetic Testing (31 oktober 2019).

Overig nieuws

• Drug-induced liver injury severity and toxicity (DILIst): binary classification of 1303 drugs by human hepatotoxicity (1 november 2019). Drug Discovery Today.
• Massachusetts General Hospital oversaw trial that led to the first death from a fecal transplant, a new paper shows (30 oktober 2019). STAT.
• A third trial oversight committee: Functions, benefits and issues (30 oktober 2019). Clinical Trials.
• In generic drug plants in China and India, data falsification is still a problem (29 oktober 2019). STAT.
• Build Quality into Trials from the Beginning to Avoid Disaster (28 oktober 2019). CenterWatch.

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Recent verschenen

• Overzicht bijeenkomsten & consultaties (1 November 2019)
• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 99 (22 oktober 2019)

Meer nieuws van elders?

• Ga naar het vernieuwde nieuwsoverzicht of news.bontrop.com

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