Uitgelicht en gespot op internet (week 24, 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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Association of Clinical Research Professionals (ACRP) 

• Bias in Electronic Health Records May Affect Clinical Trials (15-06-2023).
• Equity and bias in electronic health records data (July 2023). Contemporary Clinical Trials.

 Associatie van Contract Research Organisaties in Nederland (ACRON)

• ACRON EU CTR/CTIS klankbordgroep (14-06-2023).

BBMRI-ERIC

• BBMRI-ERIC Newsletter – June 2023 (15-06-2023).

Clinical trials, Clinical research

• Reducing bureaucracy in clinical trials in the European Union (18-06-2023). TranspariMED.
  • Reducing bureaucracy in clinical trials
    • Coalition Recommendations
    • Coalition Recommendations: summary for and by patients
• Study to test innovative decentralised clinical trial model is ready for patient recruitment (13-06-2023). Trials@Home.
• Improving access for and experience of transgender and non-binary patients in clinical research: Insights from a transgender patient focus group and targeted literature reviews (august 2023). Contemporary Clinical Trials.
• Further considerations for placebo controls in surgical trials. Trials 24, 391 (2023).
• Whose knowledge counts? Involving communities in intervention and trial design using community conversations. Trials 24, 385 (2023).
• Addressing The Gap Between Tech In Every Day Life Vs. Tech In Clinical Trials (13-06-2023). Applied Clinical Trials.
• Data-driven strategies for increasing patient diversity in Bristol Myers Squibb–sponsored US oncology clinical trials (13-06-2023). Clinical Trials.
• Research ethics committee members’ perspectives on paediatric research: a qualitative interview study (12-06-2023). Research Ethics.
• How PROs Enhance Patient Care Decisions And Future Clinical Research (12-06-2023). Clinical Leader.
• WHO: Shadow boxing continues around clinical trials (24-05-2023). TranspariMED.
• Heterogeneity of reported outcomes in epidermolysis bullosa clinical research: a scoping review as a first step towards outcome harmonization (25-04-2023), British Journal of Dermatology, 2023;, ljad077.

De onafhankelijk arts/deskundige: Is de tijd rijp om de verplichting ook voor het overig mensgebonden onderzoek te laten vervallen?

Consent, Data sharing, Privacy

• Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data (13-06-2023). Journal of Empirical Research on Human Research Ethics.
• Privacy risks of whole-slide image sharing in digital pathology. Nat Commun 14, 2577 (2023).
• Guest Post — Being Research Data (13-06-2023). The Scholary Kitchen.
• Defining the Boundaries in Clinical Trial Data Sharing (12-06-2023). Applied Clinical Trials.
• Reshaping consent so we might improve participant choice (II) – helping people decide (12-06-2023). Research Ethics.

Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS) EU CTR: Sponsors embrace the change, albeit half-heartedly (15-06-2023). Clinical Trials Arena. Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België) List of requested documents in CTIS for Belgium_update 06-06-2023. Site Suitability Template V 2.0 – March 2023, adapted for BE, June 2023. “Verplicht BE-sjabloon voor geschiktheid van de site. De nieuwe versie van 6 juni 2023, die alleen door de CEO van het ziekenhuis moet worden ondertekend, is gepubliceerd. Tot eind september 2023 kan het oude Belgische sjabloon, dat zowel door de hoofdonderzoeker als de CEO moest worden ondertekend, nog steeds voor indieningen gebruikt worden. Vanaf oktober 2023 moet het nieuwe sjabloon worden gebruikt.” bron: FAGG website ‘Europese verordening 536/2014’

Centrale Commissie Dierproeven (CCD)

• Reactie CCD op evaluatie vergunningsproces (12-06-2023).

CORE–MD (Coordinating Research and Evidence for Medical Devices)

• Perceived training needs for regulators, notified bodies and clinicians: result of CORE-MD survey (05-06-2023).

Council for International Organizations of Medical Sciences (CIOMS)

• Working Group XII – Benefit-Risk Balance for Medicinal Products

European Clinical Research Infrastructure Network (ECRIN)

• Tools – Freely accessible tools to facilitate research and the organisation of clinical trials in Europe.

European Commission, Health Technology Assessment

• Formal stakeholder body created under the Health Technology Assessment Regulation (15-06-2023).

European Medicines Agency (EMA)

• Human medicines highlights – June 2023 (16-06-2023).
• Standard operating procedure for scientific advice and protocol assistance procedure (updated 16-06-2023).

Good Clinical Practice

• The ICH E6(R3) draft Guideline presentation available now on the ICH website (13-06-2023). ICH.
  • E6(R3) Step 2 Presentation (13-06-2023). ICH.
  • E6(R3) Explanatory Video (01-06-2023). ICH.
• Modernization and patient protection at center of new US draft GCP guideline (14-06-2023). Clinical Insider.

Good Clinical Trials Collaborative

• “Time to turn words into action”: A response to O’Shaughnessy review (12-06-2023).

HollandBIO

• BIO International Convention 2023: Standing up for Science, Dutch biotech and transatlantic cooperation!  (13-06-2023).
• Micky Adriaansens & Ernst Kuipers show enthusiasm about biotech innovations during economic mission to Boston (13-06-2023).
• Minister Kuipers zoekt symbiose (13-06-2023).

International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

• IFAPP TODAY,  June 2023, Number 35 (16-06-2023).

Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG)

• Reminder: Controleer je financiële vergoedingen in Het Transparantieregister Zorg vóór 1 juli a.s.! (13-06-2023).

Boekenplank

Kunstmatige Intelligentie (KI)

• Don’t be blind to AI risks in rush to see opportunity – ICO reviewing key businesses’ use of generative AI (15-06-2023). Information Commissioner’s Office.
• Do Foundation Model Providers Comply with the EU AI Act? (15-06-2023). CRFM, HAI, Standford University.
• The ethics of disclosing the use of artificial intelligence tools in writing scholarly manuscripts (15-06-2023). Research Ethics.
• Over de AI-verordening, het wetgevingsproces van de EU en hoe wij ons hiermee bemoeien! (14-06-2023). Bits of Freedom.
• Streamlining healthcare with AI for drug development (15-06-2023). Clinical Trials Arena. 
• How using AI in clinical trials accelerates drug development (15-06-2023). Clinical Trials Arena.
• The potential of AI in pharma R&D (15-06-2023). Clinical Trials Arena.
• FDA Seeks Input On AI Adoption In Drug Development And Manufacture (14-06-2023). Clinical Leader.
• Defragmenting European Law on Medical AI (13-06-2023). Bill of Health.
• Future of ChatGPT in Pharmacovigilance. Drug Saf (2023).
• EU and US Lawmakers Agree to Draft AI Code of Conduct (12-06-2023). Covington & Burling LLP, Global Policy Watch.
• What Does a Chatbot Know About Eating Disorders? Users of a Help Line Are About to Find Out (12-06-2023). KFF Health News.
• When Doctors Use a Chatbot to Improve Their Bedside Manner (12-06-2023). The New York Times.
• Regulators Face Novel Challenges as Artificial Intelligence Tools Enter Medical Practice. JAMA Health Forum. 2023;4(6):e232300.
• Putting AI Ethics into Practice: The Hourglass Model of Organizational AI Governance. arXiv:2206.00335.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Transparency data: MHRA performance data for assessment of clinical trials and established medicines (updated 15-06-2023).

Methodologie, statistiek

• [109] Data Falsificada (Part 1): “Clusterfake” (17-06-2023). Data Colada.
• 14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (morning panel discussion) (17-06-2023). Clinical Trials.
• Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple (16-06-2023). Clinical Trials.
• Rescuing a Study in Jeopardy with Comprehensive Clinical Adjudication (16-06-2023). Clinical Research News.
• BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials (14-06-2023). Clinical Trials.
• Aanpassing van primaire eindpunten in onderzoek naar immunotherapie komt vaak voor en is niet transparant (08-06-2023). IKNL.
• Many cancer studies stealthily move goalposts, new study finds (01-06-2023). TranspariMED.
• Goed om eindpunten studies actueel en relevant te houden. VIG-reactie op onderzoek naar primaire eindpunten (08-06-2023). Vereniging Innovatieve Geneesmiddelen.
• Why do we randomize? Kaspar Rufibach
• Second things first (08-06-2023). Stephen Senn, via LinkedIn.
• Why can’t we simply get rid of RCTs? (06-06-2023). Kaspar Rufibach, via LinkedIn.
• How does the ICH E9(R1) estimands addendum fit into the picture? (07-06-2023). Kaspar Rufibach, via LinkedIn.
• Whether to randomize or not has nothing to do with the sample size of a clinical trial (08-06-2023). Kaspar Rufibach, via LinkedIn.

US Food and Drug Administration’s (FDA)

• Final guidance: Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry (22-06-2023).
• Final guidance: Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (14-06-2023).
• Decentralized Clinical Trials for Drugs, Biological Products, and Devices (15-06-2023).
• Advanced therapy medicinal products: Recent US approvals, upcoming guidance (13-06-2023). Regulatory Focus.

World Health Organization (WHO)

• An imbalanced approach to governance? An analysis of the WHO’s position on human genome editing (17-06-2023). Bioethics.

Overig

• Weekend reads: A weird scandal gets weirder; rapid onset gender dysphoria paper retracted; the effects of retractions on careers and collaborations (17-06-2023). Retraction Watch.
• Data sleuth flags 30 randomized clinical trials from researcher in Egypt (12-06-2023). Retraction Watch.
• Synthetic human embryos created in groundbreaking advance (14-06-2023). The Guardian.
• Next steps for global collaboration to minimize racial and ethnic bias in neuroscience. Nat Neurosci (2023).
• Evolution of retracted publications in the medical sciences: Citations analysis, bibliometrics, and altmetrics trends (16-06-2023). Accountability in Research.
• Advancing Rare Disease Research With Patient Registries (16-06-2023). Clinical Leader.
• Who owns your consent? How REBs give away participants’ agency (14-06-2023). Research Ethics.
• Health Research with Data in a Time of Privacy: Which Information do Patients Want? (13-06-2023). Journal of Empirical Research on Human Research Ethics.
• What’s Special About Metascience? (13-06-2023). Critical Metascience.
• Afterlife: the post-research affect and effect of software (10-06-2023). Research Ethics.

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