Uitgelicht en gespot op internet (week 47, 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.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

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Accelerating Clinical Trials in the EU (ACT EU)

• Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 October 2023) (21-11-2023).

American Psychological Association

• Introducing APA Style Journal Article Reporting Standards for Race, Ethnicity, and Culture (02-11-2023).

Belgian Association of Research Ethics Committees (BAREC)

• Guidance on Compensation of Clinical Research Participants (23-11-2023).
  • Guidance on fair compensation of subjects for their participation in clinical research in Belgium (21-11-2023).
  • Fair compensation of subjects in clinical research in Belgium

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Bereikbaarheid CCMO tijdens kerstperiode (24-11-2023).

“Voor indieningen onder de CTR geldt een winter klokstop van 22 december 2023 23:59:59 tot 8 januari 2024 00:00:01.”

bron: CCMO nieuwsbericht “Bereikbaarheid CCMO tijdens kerstperiode” d.d. 24-11-2023

Clinical trials

• Study finds only 3% of Canadian trials meet all transparency guidelines (24-11-2023). Clinical Trials Arena.
• Q&A: Data misuse and trial reporting (22-11-2023). Clinical Trials Arena.
• FDA rebuffs Entrada’s attempt to get yearlong hold on DMD drug lifted (22-11-2023). Fierce Biotech.
• Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016–2022 (22-11-2023). Clinical Trials.
• UK launches medicines scheme with £400m earmarked for clinical trials (21-11-2023). Clinical Trials Arena.
• Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies (21-11-2023). Clinical Trials.
• Clinical Research Sites Have Spoken: How Can Sponsors and CROs Improve the Site Experience? (21-11-2023). Applied Clinical Trials.
• Studie UMC Utrecht: Kan klinisch onderzoek ook remote en thuis? (20-11-2023). ICT & health.
• AstraZeneca launches new company to share digital clinical trial expertise with CROs, pharmas (20-11-2023). Fierce Biotech.
• Decentralized Clinical Trials: Being Audit Ready and Avoiding Pitfalls (20-11-2023). Applied Clinical Trials.
• Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review (20-11-2023). Clinical Trials.
• Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies (17-11-2023). Trials.
• Trial Site Selection And Design Insights For Neurodegenerative Diseases (17-11-2023). Clinical Leader.
• The Evolution of CRO and Sponsor Relationships (16-11-2023). Applied Clinical Trials.
• Streamlining Clinical Trials: Mitigation and Management (16-11-2023). Applied Clinical Trials.
• Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022. JAMA Netw Open. 2023;6(11):e2343425. doi:10.1001/jamanetworkopen.2023.43425

Diversiteit, Inclusiviteit, Representativiteit, Recruitment, Retention

• 3 Steps To Improve & Measure Your Clinical Trial Patient Diversity Efforts (22-11-2023). Clinical Leader.
• Exclusion of Women from Phase I Trials: Perspectives from Investigators and Research Oversight Officials (21-11-2023). Ethics & Human Research.
• The Importance of Diversity in Clinical Trials: A Comprehensive Analysis (21-11-2023). Clinical Research News.
• Fortrea, Medidata ink deal focused on driving diversity in clinical trials (21-11-2023). Fierce Biotech.

European Animal Research Association (EARA)

• Is ‘Rat Trap’ a fair summary of why we use animals in research? (17-11-2023).

European Commission

• Clinical Trials Highlights issue 17 – November 2023 (21-11-2023).

European Medicines Agency (EMA)

• The use of Artificial Intelligence (AI) in the medicinal product lifecycle
• Sixth Industry Standing Group (ISG) meeting (updated 24-11-2023).
• Enpr-EMA newsletter 2022 (24-11-2023).

European Parliament, Committee on the Environment, Public Health and Food Safety (ENVI)

• Consideration of draft reports on pharmaceutical package (10-11-2023).

Informed consent

• Should Chatbots Be Used to Obtain Informed Consent for Research? (21-11-2023). Ethics & Human Research.
• Is ChatGPT Listening in On Your Next Informed Consent? (16-11-2023). ACRP.
• Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members’ and Researchers’ Views (21-11-2023). Ethics & Human Research.

International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

• Ethical Innovation for Global Health (26-11-2023).
• IFAPP TODAY, november/december 2023, nr 39.

Kunstmatige intelligentie (KI)

• Hypotheses devised by AI could find ‘blind spots’ in research (17-11-2023). Nature.
• Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions. npj Digit. Med. 6, 218 (2023).
• Artificial intelligence in clinical trials in the UK and EU. Thomson Reuters Practical Law.

Medische hulpmiddelen

• CAPA versus tekortkoming, het blijft lastig (19-11-2023). Quality Business Support Blog.

Netzwerk der Koordinierungszentren für Klinische Studien (KKSNetzwerk e. V.), Deutsche Hochschulmedizin e. V., Verband der forschenden Pharma-Unternehmen (vfa), Bundesverband der Pharmazeutischen Industrie (BPI), Bundesverband Medizinischer Auftragsinstitute (BVMA) (Duitsland)

• Gemeinsame Pressemitteilung: Gemeinsame Mustervertragsklauseln 2.0: Beschleunigungshilfe für klinische Prüfungen am Studienstandort Deutschland (07-11-2023). PDF

De “Mustervertragsklauseln für klinische Prüfungen mit Arzneimitteln unter Verantwortung eines pharmazeutischen Unternehmens (industrieller Sponsor) 2.0” zijn te downloaden via:

• https://medizinische-fakultaeten.de/themen/forschung/mustervertragsklauseln
• https://www.kks-netzwerk.de/studiensupport/unterstuetzung/mustervertragsklauseln
• https://www.vfa.de/mustervertragsklauseln-fuer-klinische-pruefungen
• https://www.bpi.de/alle-themen/klinische-forschung
• https://www.bvma.de/mustervorlagen

NHS Health Research Authority (HRA)

• Strong public support for diversity in research (21-11-2023).

Pharma.be

• België riskeert verlies van honderden miljoenen aan investeringen in biofarmaceutisch onderzoek & ontwikkeling (06-11-2023).
• Oproep om de Belgische toppositie van de biofarmaceutische industrie in Europa te verdedigen (23-11-2023).
• De Belgische biofarmaceutische sector: onbetwiste Europese leider (22-11-2023).

Stichting Gedragscode Medische Hulpmiddelen

• Let op! Wijzigingen GMH Code per 1 januari 2024 (13-11-2023). Marloes Meddens-Bakker, via LinkedIn.
• Gedragscode GMH 2024 – integrale versie (per 1 januari 2024)
• GMH Nieuwsbrief 5 – Wijzigingen GMH Code per 2024 (01-11-2023).

U.S. Food and Drug Administration, U.S. Public Health Service (USPHS), National Institutes of Health (NIH)

• Final guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (24-11-2023).
• Draft guidance: Translation of Good Laboratory Practice Study Reports: Questions and Answers (21-11-2023).
• Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation – 11/09/2023 (24-11-2023).
• Drug Trials Snapshots (24-11-2023).
• 2022 Drug Trials Snapshots Summary Report (PDF)

“Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in the key clinical trials that supported the original FDA approval of new drugs by FDA’s Center for Drug Evaluation and Research.”

bron: FDA Drug Trials Snapshots

• FDA Modernizes Clinical Trials with Master Protocols (22-11-2023). FDA.

Overig

• Weekend reads: ‘A scientific fraud epidemic’; censorship by retraction; buying and selling articles (25-11-2023). Retraction Watch.
• ‘Treasure trove’ of new CRISPR systems holds promise for genome editing (23-11-2023). Nature.
• ‘Politicians don’t understand science’: advisers give evidence at UK COVID inquiry (23-11-2023). Nature.
• Developing and Launching Successful Digital Health Products: Five Considerations (november 2023). DIA Global Forum.
• EU Acts on the Promise of Artificial Intelligence for Medicinal Products (november 2023). DIA Global Forum.
• Statistics Powering Risk-Based Quality Management (november 2023). DIA Global Forum.
• Why Research Fraud Is Getting Worse (22-11-2023).  The James G. Martin Center for Academic Renewal.
• Science Sleuth Looks To Expose Research Fraud (20-11-2023). Discover Magazine.
• Healthcare Integration: How Do We Put The “Clinical” Into “Clinical Research”? (18-11-2023). Clinical Leader.
• Changing the public perception of human embryology (20-11-2023). Nature Cell Biology.
• Human fetal tissue is critical for biomedical research (16-11-2023). Stem Cell Reports.
• Does haste make waste? Prevalence and types of errors reported after publication of studies of COVID-19 therapeutics (16-11-2023). Systematic Reviews.
• Interrogating the Value of Return of Results for Diverse Populations: Perspectives from Precision Medicine Researchers (14-11-2023). AJOB Empirical Bioethics: Vol 0, No 0.
• The impact of “Five No’s for Publication” on academic misconduct (09-11-2023). Accountability in Research: Vol 0, No 0.
• What’s Trending in the World of Pseudoscience (15-09-2023). McGill.