Uitgelicht en gespot op internet (week 18 & 19, 2023)

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.

Ook zijn er weer nieuwe publieke consultaties en bijeenkomsten toegevoegd aan de ‘Consultations‘ en ‘Events‘-pagina.

Veel leesplezier!

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

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Algemene verordening gegevensbescherming (AVG), EU Data Act, Gegevensdeling, Privacy

• Proposed EU data laws leave researchers out in the cold (09-05-2023). Nature.
• EU General Court Clarifies When Pseudonymized Data is Considered Personal Data (28-04-2023). Covington.
• Handleiding Algemene Verordening Gegevensbescherming (AVG) (update 15-04-2023). Ministerie van Justitie en Veiligheid.

Association of Clinical Research Professionals (ACRP) 

• Clinical Researchers Sound Off on DCTs (01-05-2023).
• Moving from Intention to Action on Diversity, Equity, and Inclusion in Clinical Research (30-04-2023).

Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS) Review of transparency rules for the EU Clinical Trials Information System (CTIS) (03-05-2023). EMA. CTCG, Simultaneous National Scientific Advice (SNSA) Updated ‘Simultaneous National Scientific Advice (SNSA)’ European Medicines Agency (EMA) Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 (03-05-2023). Annex – Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 (03-05-2023). CTIS newsflash – 5 May 2023 Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 March 2023, edition 12) (03-05-2023).

Clinical trials

• Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials (11-05-2023). Clinical Leader.
• Parkinson’s Disease Trials Need Better Markers Of Cognitive Changes (10-05-2023). Clinical Research News.
• Study: Most oncology drugs approved in Japan based on surrogate endpoints do not undergo confirmatory trials ( 04-05-2023). RAPS Regulatory Focus.
• The End of the Beginning for Digital Endpoints? (01-05-2023). Applied Clinical Trials.
• A pathway for replacing costly TQT studies (08-05-2023). Applied Clinical Trials.
• Why Clinical Site Awareness Should Be “Day Zero” For SUSAR Reporting (04-05-2023). Clinical Leader.
• Flawed protocol for levodopa clinical trial brings retractions (09-05-2023). Spectrum.
• Clinical trials for Alzheimer’s treatments need to include people with Down syndrome (05-05-2023). STAT.
• Stensland, K.D., Sales, A.E., Vedapudi, V.K. et al. Exploring implementation outcomes in the clinical trial context: a qualitative study of physician trial stakeholders. Trials 24, 297 (2023).
• Coffey, T., Duncan, E., Morgan, H. et al. Developing strategies to address disparities in retention communication during the consent discussion: development of a behavioural intervention. Trials 24, 296 (2023).
• Corrigan, N., Brown, J.M., Emsley, R. et al. Surgical trial design for incorporating the effects of learning: what is the current methodological guidance, and is it sufficient?. Trials 24, 294 (2023).
• Optimizing Clinical Trials through Ethical Technology. A Regulatory Perspective for Non-Technical Users (mei 2022). DIA Global Forum.

Clinical trial results reporting

• NIH blocks projects of researchers who fail to make clinical trial results public (11-05-2023). TranspariMED.
• The bizarre story of an American clinical trial that became lost in an Australian woodland (11-05-2023). TranspariMED.
• Our volunteers just rescued several clinical trials from becoming research waste. Here’s how (07-05-2023). TranspariMED.

College ter Beoordeling van Geneesmiddelen (CBG)

• Column ‘Over medicijnen’: Waarom wetenschap? Het is de basis van ons werk (03-05-2023).

Council for International Organizations of Medical Sciences (CIOMS)

• CIOMS Cumulative Glossary, with a focus on Pharmacovigilance (Version 2.1) (updated 04-05-2023).

CROMSOURCE

• CROMSOURCE Regulatory Newsletter January – March 2023

Decentralized Clinical Trials

• Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials (05-05-2023). FDA Law Blog, Hyman, Phelps & McNamara, P.C..
• FDA Issues New Draft Guidance on DCTs (03-05-2023). Applied Clinical Trials.
• FDA Eyes New Strategies to Spur Gene Therapy Development (03-05-2023). Applied Clinical Trials.
• FDA issues draft guidance on decentralized clinical trials (02-05-2023). Regulatory Focus.
• FDA Takes Additional Steps to Advance Decentralized Clinical Trials (02-05-2023). FDA.
• Decentralised clinical trials: ethical opportunities and challenges (25-04-2023). The Lancet.

Dierexperimenteel onderzoek

• Film highlights the need for monkeys in brain research (02-05-2023). European Animal Research Association.
• Supply of monkeys for research is at a crisis point, U.S. government report concludes (04-05-2023). Science.
• Leading primate researcher demoted after admitting he faked data (03-05-2023). Retraction Watch.

Drug development

• Phase 1 Strategies To Optimize Orphan Drug Development (13-05-2023). Clinical Leader.
• FDA: Artificial Intelligence and Machine Learning (AI/ML) for Drug Development
• FDA: Discussion paper – Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products
• FDA: Discussion paper – Artificial Intelligence in Drug Manufacturing

Dutch Oncology Research Platform (DORP)

• NKR-gegevens en klinisch onderzoek (11-05-2023).

Genome editing, Mitochondrial donation treatment (MDT), Organoids

• Human embryo science: can the world’s regulators keep pace? (10-05-2023). Nature.
• New precision-breeding law unlocks gene editing in England. Nat Biotechnol (2023).
• Ethical Issues in Cerebral Organoid Research (10-05-2023). Cambridge Quarterly of Healthcare Ethics.
• First UK children born using three-person IVF: what scientists want to know (10-05-2023). Nature.
• First UK baby with DNA from three people born after new IVF procedure (09-05-2023). The Guardian.

Informed consent

• Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure. Trials 24, 305 (2023).
• eConsent is Not What You Think (12-05-2023). Applied Clinical Trials.
• Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent (11-05-2023). Ethics & Human Research.

Integriteit

• Handboek integriteit beschikbaar voor gemeenten, provincies en waterschappen (09-05-2023). Rijksoverheid.

Kunstmatige Intelligentie (KI, AI)

• For Ethical Use of AI in Medicine, Don’t Overlook Maintenance and Repair (09-05-2023). The Hastings Center.
• Perspectives of Youths on the Ethical Use of Artificial Intelligence in Health Care Research and Clinical Care. JAMA Netw Open. 2023;6(5):e2310659. doi:10.1001/jamanetworkopen.2023.10659

Medical Device Regulation (MDR) Commission Guidance on the content and structure of the summary of the clinical investigation report – May 2023 (2023/C 163/06). European Commission. Euro Roundup: EC posts guidance on summary of MDR clinical investigation reports (11-05-2023). Regulatory FOcus.

Medische hulpmiddelen,

• What does it mean to call a medical device invasive?. Med Health Care and Philos (2023). 

Methodologie

• Design and statistics of pharmacokinetic drug-drug, herb-drug, and food-drug interaction studies in oncology patients (juli 2023). Biomedicine & Pharmacotherapy.
• Using re-randomisation designs to increase the efficiency and applicability of retention studies within trials: a case study. Trials 24, 299 (2023).
• Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial (12-05-2023). Clinical Trials.
• Using the Delphi process to determine the minimum clinically important effect size for the Balanced-2 randomised controlled trial (05-05-2023). Clinical Trials.
• Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support (05-05-2023). Clinical Trials.
• Identifying spin bias of nonsignificant findings in biomedical studies. BMC Res Notes 16, 50 (2023).
• De oncologie heeft behoefte aan innovatieve studie designs – Associate prof lecture dr. Van de Ven (18-04-2023). UMC Utrecht, via YouTube.

National Academies of Sciences, Engineering, and Medicine

• Gaps in the Systems That Support NIH-Funded Research Using Nonhuman Primates Are Undermining U.S. Biomedical Research and Public Health Readiness, Says New Report (04-05-2023).

Nuffield Council on Bioethics

• The future of ageing (25-04-2023).
  This report sets out an ethical framework and recommendations for research and innovation related to ageing.

Organisation for EconomicCo-operation and Development (OECD)

• Moving forward on data free flow with trust: New evidence and analysis of business experiences (2023), OECD Digital Economy Papers, No. 353, OECD Publishing, Paris,

Patiëntenparticipatie

• ‘The best way to get it right is to listen to us’ — autistic people argue for a stronger voice in research (10-05-2023). Nature.
• Patiëntenparticipatie in onderzoek | UMC Utrecht (15-04-2023). Via YouTube.
• The opportunity for greater patient and public involvement and engagement in drug development and regulation (25-02-2023). Nature Reviews Drug Discovery.

US Food and Drug Administration’s (FDA)

• Study Data Standards Resources (12-05-2023).
• Stakeholders want more clarity from FDA on using data from externally controlled trials (03-05-2023). RAPS Regulatory Focus.
• FDA Eyes New Strategies to Spur Gene Therapy Development (03-05-2023). Applied Clinical Trials.
• Accelerated approval draft guidance paves way for ‘one-trial’ programmes, warns against single-armed trials (11-04-2023). Nature Reviews Drug Discovery.
• Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny (27-03-2023). Med Device Online.

Wet kwaliteitsregistraties zorg

• Nota naar aanleiding van het verslag (09-05-2023). Mnister van Volksgezondheid, Welzijn en Sport

Overig

• Weekend reads: Paying cash to boost rankings; billions lost from reformatting manuscripts; ‘the truth police’ (13-05-2023). Retraction Watch.
• Weekend reads: Men vs. women in fraud; how to improve peer review; homeopathy data manipulation (06-05-2023). Retraction Watch.
• Improving Use of Epidemiological Data to Serve Patients Better: A Colombian Initiative (mei 2022). DIA Global Forum.
• Homeopathy Research Hits New Low (May/June 2023). Skeptical Inquirer
• Exploring HIV/AIDS investigator perceptions of equity within research partnerships between low-and middle-income and high-income countries: a pilot survey. Health Res Policy Sys 21, 32 (2023).
• Nature editors retract influential cancer paper with “unreliable” data  (01-05-2023). Retraction Watch.
• The boundary problem: Defining and delineating the community in field trials with gene drive organisms (03-05-2023). Bioethics
• Alleviating the burden of malaria with gene drive technologies? A biocentric analysis of the moral permissibility of modifying malaria mosquitoes. Journal of Medical Ethics Published Online First: 28 February 2023. doi: 10.1136/jme-2022-108359
• Community Engagement in Precision Medicine Research: Organizational Practices and Their Impacts for Equity, AJOB Empirical Bioethics, DOI: 10.1080/23294515.2023.2201478
• Now 18, the first child to ever receive CAR-T cancer therapy is ready for a new identity (03-05-2023). STAT.

Now 18, the first child to ever receive CAR-T cancer therapy is ready for a new identity

• Data Matters: Creating the Perfect Health Research Cohort (12-05-2023). Clinical Research News.
• Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research (11-05-2023). Ethics & Human Research.
• A Competency Framework for Health Research Ethics Educational Programs: Results from a Stakeholder‐Driven Mixed‐Method Process (11-05-2023). Ethics & Human Research.
• Overcoming Complexity-Change-Challenge (10-05-2023). Applied Clinical Trials.
• Genetic and Genomic Researchers’ Perspectives on Biological Sample Sharing in Collaborative Research in Uganda: A Qualitative Study (08-05-2023). Journal of Empirical Research on Human Research Ethics.
• Investment to Create Pan-European CRO (04-05-2023). Applied Clinical Trials.
• Why do some academics so often publish (letters) outside their field? (04-05-2023). Accountability in Research.

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