Uitgelicht en gespot op internet (week 49, 2022)

Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn en Mastodon.

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Prettige Kerstdagen en een heel gelukkig 2023!

Algemene verordening gegevensbescherming (AVG), Standard Contractual Clauses, WGBO

• 27 december 2022: deadline gebruik oude modelcontracten (Standard Contractual Clauses) (08-12-2022). Dirkzwager.
• Herzien: KNMG-richtlijn Omgaan met medische gegevens (05-12-2022). KNMG.
  • KNMG-richtlijn Omgaan met medische gegevens (december 2022).
• Wanneer mag of moet ik een medisch dossier vernietigen? (02-12-2022). NTvG.

Clinical trials

• Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials? (30-11-2022). The American Journal of Bioethics.

Guidance on the mutual acceptance of EU Digital COVID Certificates issued to participants of clinical trials for COVID-19 vaccines published by European Commission

Clinical Trials Regulation (CTR)

• Gemeinsame Pressemitteilung: Massive Funktionsprobleme des EU-Portals CTIS für Klinische Prüfungen bedrohen die Arzneimittelforschung in Europa (28-11-2022). Bundesverband der Pharmazeutischen Industrie e.V. (BPI).
• Massive Functional Problems of the EU Clinical Trials Portal CTIS Threaten Drug Research in Europe (28-11-2022). Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland (AKEK).
• ‘Dysfunctional’ trial registry threatens drug research across Europe (06-12-2022). TranspariMED.
• Ärzte befürchten Chaos bei klinischen Studien (01-12-2022). Süddeutsche Zeitung.

Clinical trials results reporting

• Study finds that regulation is key to getting all Canadian clinical trial results reported (08-12-2022). TranspariMED.

College ter Beoordeling van Geneesmiddelen (CBG)

• Nieuwste editie Regulatory Science Magazine (07-12-2022).
• Regulatory Science Magazine, editie 15 (05-12-2022).

Diversity

• Next on diversity: inclusion of participants with cognitive impairment in clinical trials (08-12-2022). Clinical Trials Arena.
• ‘All the tech in the world doesn’t solve this’: Rare disease experts push biopharma on equity (08-12-2022). STAT.

Dutch Oncology Research Platform (DORP)

• Het betrekken van patiënten bij klinisch onderzoek via NFK (09-12-2022).
• Webinar over Master Protocols nu terug te kijken (05-12-2022).
• Terugkijken: Webinar Master Protocols (06-12-2022). IKNL, via YoutTube.

Dutch Clinical Research Foundation (DCRF)

• Verslag najaarssymposium V&VN Research Professionals (07-12-2022).

Ethics Committees, IRB’s

• Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes (08-12-2022). Journal of Empirical Research on Human Research Ethics.

European Clinical Research Infrastructrure Network (ECRIN)

• ‘Rare Disease Moonshot’ – Scaling-up public-private partnerships to accelerate research into world’s rarest diseases (08-12-2022).
• New EOSC-Life publication: An iterative and interdisciplinary categorisation process towards FAIRer digital resources for sensitive life-sciences data (07-12-2022).
• ISIDORe launches 4 additional calls for proposals (07-12-2022).
• CTU Day 2022 (07-12-2022).

European Medicines Agency (EMA)

• ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies (08-12-2022).

Gen- en celtherapie

• Gentherapie: meepraten over moeilijke materie (13-09-2022). EUPATI.
• What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough? (08-12-2022). FDA Law Blog, Hyman, Phelps & McNamara, PC.
• ‘Gen- en celtherapieën zijn straks niet meer weg te denken’ (25-11-2022). Pharmaceutisch Weekblad.

Health-RI

• Obstakel Verwijder Traject Health-RI: van obstakels naar concrete oplossingen voor de komende jaren (09-12-2022).

Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)

• Verlenging deadline MDR (10-12-2022). Quality Business Support Blog.
• European Council members support proposal to delay MDR deadlines (09-12-2022). Regulatory Focus.
• Exclusive: EU to propose delay to medical device law amid supply worries (08-12-2022). Reuters.
• Recon: European Commission to propose MDR delay; FDA authorizes bivalent shots for children as young as 6 months (08-12-2022). Regulatory Focus.
• Euro Roundup: EU issues implementing regs for devices without an intended medical purpose (08-12-2022). Regulatory Focus.
• IGJ onderzoekt hoe fabrikanten omgaan met de IVDR (06-12-2022). HollandBIO.
• MDCG 2022-17 – MDCG position paper on ‘hybrid audits’ – December 2022 (06-12-2022). Medical Device Coordination Group (MDCG).
  • MDCG offers clarity on ‘hybrid’ audits under MDR, IVDR (06-12-2022). Regulatory Focus.
• Medical devices. European Medicines Agency (EMA).

Medicines and Healthcare products Regulatory Agency (MHRA), Verenigd Koninkrijk

• When is a clinical trial halt not a clinical trial halt? (08-12-2022). Blog MedRegs.

Nationaal Comité advies dierproevenbeleid (NCad)

• ​​​​​​​Inschrijven voor workshops Inschatten en rapporteren van ongerief (07-12-2022).

Paediatric research, Vaccine trials

• Does the light at the end of the tunnel shine for everyone? The need for early paediatric participation in vaccine trials during infectious pandemics (30-07-2021). Clinical Ethics.

PGO Support

• 8 tips: hoe bereik je meer jongeren? (30-11-2022)
• Advies participatie bij onderzoek.

Recruitment, Retention

• Would you join a clinical trial advertised on Facebook? The ethics of dementia research content on social media (07-12-2022). Neuroethics at the Core.
• Dementia Research on Facebook and Twitter: Current Practice and Challenges (08-11-2022) .Journal of Alzheimer’s Disease.
• Predictors of participants’ retention—socioeconomic factors or nonadherence: insights from a urological clinical prospective study (02-12-2022). Trials.

Regulatory Science Network Netherlands (RSNN)

• RSNN annual workshop (05-12-2022). CBG Regulatory Science.

Research integrity, Replication crisis

• Guidance on research integrity provided by pan-European discipline-specific learned societies: A scoping review (08-12-2022). Science and Public Policy.
• Deze jonge wetenschappers werken aan cultuurverandering (05-12-2022). Amazing Erasmus MC.
• A call for error management in academic clinical research (04-12-2022). Journal of Clinical Epidemiology.
• Indicators of questionable research practices were identified in 163,129 randomized controlled trials (02-12-2022). Journal of Clinical Epidemiology.

Towards the European Health Data Space (TEHDAS)

• 7 vragen en antwoorden over impact EHDS op Wegiz (09-12-2022). Ministerie van Volksgezondheid, Welzijn en Sport (VWS).
• TEHDAS outlines key issues and considerations on data altruism (05-12-2022).

US Food and Drug Administration (FDA), Verenigde Staten

• Final guidance: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (05-12-2022).
• Draft guidance: Statistical Approaches to Establishing Bioequivalence (02-12-2022).
  • FDA updates statistical approaches for assessing bioequivalence (02-12-2022). Regulatory Focus.
• Top FDA official reflects on compliance actions in 2022 (09-12-2022). Regulatory Focus.
• FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors (08-12-2022). Regulatory Focus.
• Recon: Neuralink faces federal probe over animal tests; Emergent nabs priority review for OTC opioid overdose drug (06-12-2022). Regulatory Focus.
• Exclusive: Musk’s Neuralink faces federal probe, employee backlash over animal tests (06-12-2022). Reuters.

World Conference on Research Integrity

• Security considerations should never limit research integrity – side event on Integrity and Security in the Global Research Ecosystem of World Science Forum – Cape Town, South Africa (06-12-2022). Lex Bouter, via Dropbox.com.

Overig

• Weekend reads: Errors in clinical trials; GPT-3 and scientific papers; paleontologist accused of faking data (10-12-2022). Retraction Watch.

• CROs struggling to find staff with the skills to run cancer drug trials (06-12-2022). Clinical Insider.
• Before making unbiased pulse oximeters, researchers need a better way to measure skin tone (05-12-2022). STAT.
• Unnecessary Research Bureaucracy is Killing Academic Productivity, But it IS Fixable (05-12-2022). The Scholary Kitchen.
• Would you consider donating your left-over embryos to treat Parkinson’s disease? Interviews with individuals that underwent IVF in Sweden. BMC Med Ethics 23, 124 (2022).
• Legal reform to enhance global text and data mining research (01-12-2022). Science.
• Advice on Preparing for Regulatory Inspections (01-12-2022). Applied Clinical Trials.
• Demonstration of the VODAN Africa Platform – Data Pipeline, FAIR Principles, and FAIR Data Stewardship (30-11-2022). VODAN Africa.

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