Uitgelicht en gespot op internet (week 28, 29, 30, 31, 32, 33 & 34, 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.

Vanwege mijn verlof en andere werkzaamheden ben ik de afgelopen weken niet in de gelegenheid geweest om een nieuwe ‘Uitgelicht en gespot op internet‘ te publiceren. Vandaar dat het even stil was. Inmiddels heb ik (tijdens de terugvlucht) mijn mailbox weer op nieuwtjes kunnen screenen om weer een nieuw overzicht samen te kunnen stellen.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

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Algemene verordening gegevensbescherming (AVG), EU-US Data Privacy Framework, Informatiebeveiliging

• Vragen over NEN 7510. IGJ.
• Commercial sector: adequacy decision on the EU-US Data Privacy Framework (10-07-2023). Europese Commissie.
  • Questions & Answers: EU-US Data Privacy Framework (10-07-2023).
• European Commission publishes FAQ on EU-US Data Privacy Framework, and other updates (11-07-2023). IAPP.
• A guide to sharing open healthcare data under the General Data Protection Regulation (24-06-2023). Scientific Data.

Belgian Association of Research Ethics Committees (BAREC)

• Final Advise Clinical studies with questionnaires (16-08-2023).

Biobank, Henrietta Lacks

• Who owns your cells? Legacy of Henrietta Lacks raises ethical questions about profits from medical research (18-08-2023). Cleveland.com.
• How the ‘groundbreaking’ Henrietta Lacks settlement could change research (03-08-2023). Nature.
• Henrietta Lacks’ family celebrates settlement over stolen HeLa cells (01-08-2023). The Baltimore Banner.
• Medical exploitation of Black people in America goes far beyond the cells stolen from Henrietta Lacks that produced modern day miracles (08-08-2023). The Conversation.
• Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity (10-07-2023). Developing World Bioethics.
• Bioethical implications of organ-on-a-chip on modernizing drug development (14-08-2023). Artificial Organs.

Clinical Trials Regulation (CTR) Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (04-07-2023). Appendix III b – Information to be submitted with a notification of a serious breach – Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (04-07-2023). Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 June 2023, edition 15) (20-07-2023). Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 May 2023, edition 14) (17-07-2023). Clinical Trials Coordination and Advisory Group (CTAG) CTAG Meeting 12-06-2023 minutes (18-08-2023). Clinical Trials Information System (CTIS) Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.1 (12-07-2023). Annex I – Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.1 (12-07-2023). Annex II – Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information system (CTIS) (12-07-2023). CTIS newsflash – 18 August 2023. CTIS newsflash – 4 August 2023. CTIS newsflash – 21 July 2023. CTIS newsflash – 7 July 2023. Centrale Commissie Mensgebonden Onderzoek (CCMO) Nieuwsbrief CCMO ‘CTR-themanummer’: Transitiestudies: cijfers, leidraad, aanbiedingsbrief, substantiële wijziging en validatie (juli 2023). Centrale Commissie Mensgebonden Onderzoek. Dutch Clinical Research Foundation (DCRF) DCRF survey Clinical Trial Regulation (16-08-2023). Interview met Monique Al over Accelerating Clinical Trials in the EU (ACT-EU) (13-07-2023). Overig nieuws Playing Catch-Up with Europe’s Decline in Attracting Clinical Trials (17-07-2023). Applied Clinical Trials.

Clinical trial results reporting

• Over 4,000 clinical trials violate U.S. law. The FDA sent only one warning letter (16-08-2023). TranspariMED.
• German patient groups call for clinical trial transparency law (15-08-2023). TranspariMED.
• German ministries refuse to tackle research waste in clinical trials (23-07-2023). TranspariMED.

Clinical Trials Transformation Initiative (CTTI)

• FDA, CTTI Convening Virtual Public Workshop on Enhancing Clinical Study Diversity (23-08-2023).

CROMSOURCE

• CROMSOURCE Regulatory Newsletter April – June 2023

Embryo

• Ethical, legal, regulatory, and policy issues concerning embryoids: a systematic review of the literature (21-08-2023). Stem Cell Research & Therapy.
• An ethical framework for human embryology with embryo models (17-08-2023). Cell.
• New definition of a human embryo proposed amid rapid scientific advances (17-08-2023). STAT.
• Human stem cell-derived embryo models: Toward ethically appropriate regulations and policies (03-07-2023). Cell Stem Cell.

European Medicines Agency (EMA), Good Clinical Practice (GCP)

• Q&A: Good clinical practice (GCP) (updated 21-08-2023).
  • B.19: What are the expectations for distribution of updated Investigator’s Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites/ investigators? New August 2023
• Informed consent for paediatric clinical trials in Europe 2015 (updated 09-08-2023).
• Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP) (updated 01-08-2023).
• Scientific guideline: Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies (31-07-2023).
• Guidance on good manufacturing practice and good distribution practice: Questions and answers (25-07-2023).
• Paving the way towards coordinated clinical trials in public health emergencies in the EU (25-07-2023).
• Real-world evidence framework to support EU regulatory decision-making: Report on the experience gained with regulator-led studies from September 2021 to February 2023 (19-07-2023).
• Infosheet: EMA review of real-world data studies (19-07-2023).
• Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (12-07-2023).

Fraud, Misconduct, Integrity, Pseudoscience

• LUMC lijkt de dupe van fraude met Brusselse subsidie (22-08-2023). Skipr.
• There’s far more scientific fraud than anyone wants to admit (09-08-2023). The Guardian.
• Fraud holds back research (07-08-2023). Bangkok Post.
• The detection and management of attempted fraud during an online randomised trial (04-08-2023). Trials.
• Alzheimer’s drug trials plagued by lack of racial diversity (03-08-2023). Nature.
• 5 tips for using PubPeer to investigate scientific research errors and misconduct (01-08-2023). The Journalist’s Resource.
• Did an honesty researcher fabricate data? (28-07-2023). NPR.
• Amid Indian Nationalism, Pseudoscience Seeps Into Academia (26-07-2023). Undark.
• The trinity of good research: Distinguishing between research integrity, ethics, and governance (25-07-2023). Accountability in Research.
• Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed? (18-07-2023). Nature.
• Researchers on research integrity: a survey of European and American researchers [version 1; peer review: 3 approved]. F1000Research 2023, 12:187.

Implementation science, Research Embedded into Care

• What is the role of randomised trials in implementation science? (16-08-2023). Trials.
• Response to Open Peer Commentaries on “Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded into Care” (14-07-2023). The American Journal of Bioethics, 23:8, W1-W3.
• Reporting guidelines relevant to implementation studies. Improving the quality and transparency of implementation study reporting: a consolidation of reporting guidelines relevant to implementation studies (2023). National Institute for Health Research Applied Research Collaboration South London (NIHR ARC South London).

Kunstmatige Intelligentie (KI)

• AI and new standards promise to make scientific data more useful by making it reusable and accessible (21-08-2023). The Conversation.
• The Role of Artificial Intelligence in Building Responsible Open Science Infrastructures (17-08-2023). BMJ.
• ChatGPT-like AIs are coming to major science search engines (02-08-2023). Nature.
• Guidance: Software and Artificial Intelligence (AI) as a Medical Device (updated 26-07-2023). MHRA.
• EMA publishes first draft of reflection paper on the use of AI in the medicinal product lifecycle (25-07-2023). BioSlice Blog.
• Not Quite AI-mazing: Why We’re Not Ready to Rely on AI for Clinical Trial Disclosure Requirements (20-07-2023). Francine Lane, via LinkedIn.
• Reflection paper on the use of artificial intelligence in the lifecycle of medicines (19-07-2023). EMA.
• The use of Artificial Intelligence (AI) in the medicinal product lifecycle (19-07-2023). EMA.
• What Should ChatGPT Mean for Bioethics? (13-07-2023), The American Journal of Bioethics
• GPT-powered Drug Discovery: Meet DrugGPT, the Game-Changing “ChatGPT” for Ligand Design (05-07-2023). CBIRT.
• Resources for Ethical Issues in the Use of Artificial Intelligence (AI) in Human Subjects Research (15-02-2023). Learn eCore.
• OECD AI Principles overview

Medicines and Healthcare products Regulatory Agency (MRHA)

• Clinical Trials Performance Metrics: July 2022 – July 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments’ & ‘Performance Metrics January 2023 – June 2023: Assessment of New Marketing Authorisation Applications and Variations (15-08-2023).

Medische hulpmiddelen, Implantaten

• Continuing trial responsibilities for implantable neural devices (14-08-2023). Neuron.

Methodologie, Statistiek

• Rating versus ranking in a Delphi survey: a randomized controlled trial (18-08-2023). Trials.
• Assessing the use of observational methods and real-world data to emulate ongoing randomized controlled trials (17-08-2023). SCT.
• Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm (08-08-2023). Trials.
• The importance of clinical importance when determining the target difference in sample size calculations (04-08-2023). Trials.
• Evaluation of non-clinical toxicity studies of COVID-19 vaccines (august 2023). Regulatory Toxicology and Pharmacology.
• Futility in Clinical Trials (31-07-2023). JAMA. 2023;330(8):764–765.
• Being Just about Adjustment in Clinical Trials (14-07-2023). Stephen Senn, via LinkedIn.
• A Very Short List of Common Pitfalls in Research Design, Data Analysis, and Reporting. PRiMER. 2022;6:26.
• Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool (06-07-2023). Trials.
• Studies on Reliability and Measurement Error of Measurements in Medicine – From Design to Statistics Explained for Medical Researchers. Patient Relat Outcome Meas.

National Academies of Sciences, Engineering, and Medicine

• Research with Pregnant and Lactating Persons: Mitigating Risk and Liability: Proceedings of a Workshop–in Brief. Washington, DC: The National Academies Press.

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 175 (31-07-2023).

Organisation for Economic Co-operation and Development (OECD)

• COVID-19 and policy for science (03-07-2023).

Palga

• Voor onderzoekers: Palga levert gegevens uit de landelijke databank voor wetenschappelijk onderzoek.

Paediatric Clinical Trials

• Cross-border Paediatric Clinical Trials in Europe: language challenges (30-07-2023). Begoña Nafría Escalera, via LinkedIn.
• Accessibility in Rare Disease Paediatric Clinical Trials. Summer 2023 Volume 15 Issue 2. Clinical and Medical Research.

Predatory journals

• Predatory journals entrap unsuspecting scientists. Here’s how universities can support researchers (15-08-2023). Nature.

Subjects, Inclusion, Diversity, Representative, Retention

• The definition of clinical trial diversity must include disabled people (17-08-2023). STAT.
• Waarom vrouwen niet meedoen aan klinisch onderzoek naar hart- en vaatziekten en dit wel noodzakelijk is (01-08-2023). Hartstichting.
• A response to Al et al. Trials 2023;24:233. Trials 24, 525 (2023).
  • Changing patient preferences toward better trial recruitment: an ethical analysis. Trials. 2023;24:233.
• 22q11.2 deletion syndrome and a participatory approach to research (23-07-2023). Mindo.ie.
• Why do older adults decline participation in research? Results from two deprescribing clinical trials (18-07-2023). Trials.
• Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design (18-07-2023). Trials.
• Do you take part in genetic studies? That might be in your genes (17-07-2023). Nature.

UK Research Integrity Office (UKRIO)

• Breaches in Research Integrity (19-07-2023). via LinkedIn.

UK Trial Managers’ Network (UKTMN)

• The Guide to Efficient Trial Management. This Guide describes the process of managing clinical trials and gives an overview of the trial management framework (27-07-2023).

US Food and Drug Administration’s (FDA)

• Informed Consent. Guidance for IRBs, Clinical Investigators, and Sponsors (August 2023).
• Draft guidance: Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (10-08-2023).
• Draft guidance: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Draft Guidance for Industry and Food and Drug Administration Staff (28-07-2023)
• Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk (25-07-2023).
• M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of CompoundSpecific Acceptable Intakes Guidance for Industry (25-07-2023).
• Questions and Answers | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk: Guidance for Industry (25-07-2023).
• Draft guidance: Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry (14-07-2023).
• Draft guidance: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry (12-07-2023).
• Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development (24-08-2023). FDA Law Blog.
• Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient safety (18-08-2023). Regulatory Focus.
• FDA issues final guidance on obtaining informed consent in drug and device clinical trials (15-08-2023). Regulatory Focus.
• FDA issues blitz of warning letters over testing violations and refusing records requests (09-08-2023), Regulatory Focus.
• Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance (07-08-2023), Regulatory Focus.
• Industry groups call for better alignment between decentralized, centralized trials (04-08-2023), Regulatory Focus.

World Health Organization (WHO)

• WHO’s first traditional medicine summit splits opinions (18-08-2023). Nature.

Overig

• Development and validation of a novel personalized electronic patient-reported outcome measure to assess quality of life (Q-LIFE): a prospective observational study in people with Cystic Fibrosis (august 2023). eClinical Medicine.
• Paper that helped form basis of pricy research tool retracted (24-08-2023). Retraction Watch.
• US NIH turns to PPD to support transplant-related clinical trials (22-08-2023). Clinical Insider.
• A decade of surveys on attitudes to data sharing highlights three factors for achieving open science (22-08-2023). LSE.
• Geneesmiddelenonderzoek in lage- en midden-inkomenslanden (15-08-2023). NTvG.
• Decisions, Decisions, Decisions: An Ethnographic Study of Researcher Discretion in Practice.” MetaArXiv, 7 Aug. 2023. Web.
• Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals (07-08-2023). Trials.
• Should infectious disease modelling research be subject to ethics review? (04-08-2023). Philosophy, Ethics, and Humanities in Medicine.
• I love it when a plan comes together (03-08-2023). Quality Business Support Blog.
• Model-Informed Drug Development: Steps Toward Harmonized Guidance (03-08-2023). Clinical Pharmacology & Therapeutics.
• Exclusive: Shake-up at top psychiatric institute following suicide in clinical trial (31-07-2023). Spectrum.
• NIH launches clinical trials and new research office for long Covid (31-07-2023). STAT.
• Deze goedkope jichtpil bleek goed voor hartpatiënten, maar werd gekaapt door een sluwe farmaceut (31-07-2023). De Volkskrant.
• Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors (28-07-2023). JAMA Network Open.
• The value of clinical trial medication and yearly medicine cost avoidance from clinical trials conducted by the pharmaceutical industry in Finland (26-07-2023). Internation Journal of Clinical Trials.
• Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved. PLOS ONE 18(7): e0288083.
• Translational or translationable? A call for ethno-immersion in (empirical) bioethics research (21-07-2023). Translation Bioethics.
• Legislative change is afoot for clinical trials conducted in the UK (21-07-2023). BioSlice Blog.
• Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches (22-06-2023). Applied Clinical Trials.
• Ensuring Ethical Postprogression Therapy for Patients in Randomized Trial Control Arms. J Clin Oncol. 2023 Jun 21.
• ICTD 2023: Decentralised Clinical Trials – Challenges and Opportunities (13-06-2023). ECRIN.
• Making administrative healthcare systems clinical data the future of clinical trials: lessons from BladderPath, by Mintz HP, Dosanjh ARS, Parsons H, et al, in BMJ Oncology

Ben jij iemand die vaak online vragenlijsten invult? Doe de test!

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