Uitgelicht en gespot op internet (week 23, 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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Clinical trials, Clinical research

• Obtaining Informed Consent for Future Reuse of Patient Data (08-06-2023). Applied Clinical Trials.
• The future of clinical trials and drug development: 2050 (08-06-2023). Drugs Context.
• Aanpassing primaire eindpunten in onderzoek immuuntherapie komt vaak voor. Onderzoekers roepen op tot meer transparantie (09-06-2023). Radboudumc.
  • Changes to Primary End Points in Randomized Clinical Trials on Immune Checkpoint Inhibitors in Urothelial, Renal Cell, and Lung Cancers: A Systematic Review. JAMA Oncol. Published online June 08, 2023.
• The Preregistration Prescriptiveness Trade-Off and Unknown Unknowns in Science (07-06-2023). Critical Metascience.
• Researchers’ decision making: Navigating ambiguity in research practice (23-05-2023). Center for Open Science, via YouTube.
• Peer review before trial conduct could increase research value and reduce waste (05-06-2023). Journal of Clinical Epidemiology.
• Handling intercurrent events and missing data in non-inferiority trials using the estimand framework: A tuberculosis case study (06-06-2023). Clinical Trials.
• Varieties of Community Uncertainty and Clinical Equipoise. Kennedy Institute of Ethics Journal 33(1), 1-19.
• Reporting of PPI and the MCID in phase III/IV randomised controlled trials—a systematic review. Trials 24, 370 (2023).
• Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol. Trials 24, 367 (2023).
• Vaccine development during a pandemic: General lessons for clinical trial design (09-05-2023). Statistics in Biopharmaceutical Research.
• Is Deception in Research Ethical? (07-06-2023). Learn eCore.

College ter Beoordeling van Geneesmiddelen (CBG)

• Column ‘Over medicijnen’: Maatwerkmedicijn (07-06-2023).

Council for International Organizations of Medical Sciences (CIOMS)

• Working Group XIII – Real-World Data and Real-World Evidence in Regulatory Decision Making
  • CIOMS Working Group report ‘Real-world data and real-world evidence in regulatory decision making’ (draft 06-06-2023).

DIA Global Forum

• Data Analytics Could Enable Trial Diversity and Meet New Regulations.
• Digital Transformation is Much More Than a Noun. Act Today for Modern Collaboration Tomorrow.
• PHUSE’s Educational Videos on Data Privacy and Data Sharing in Clinical Trials. The Power of Collaboration in Enhancing Health Literacy and Making Information Accessible to All.

Dutch Clinical Research Foundation (DCRF)

eConsent in klinisch onderzoek: hoe pak ik dit aan?!

EU Pharma Legislation

• EU Pharma Legislation Review Series: Marketing Authorisations (02-05-2023). Inside EU Life Sciences, Covington.

European Health Data Space (EHDS)

• Joint Statement: Health organisations define EHDS’ opt out required for life saving research (06-06-2023). BBMRI-ERIC.

European Medicines Agency (EMA)

• EMA Management Board: highlights of June 2023 meeting (09-06-2023).
• Informed consent for paediatric clinical trials in Europe 2015 (updated 07-06-2023). Enpr.
  • Data for Belgium were updated in June 2022

Good Clinical Practice (GCP)

• GCP update: FDA opens clinical trial draft guidance for comments (08-06-2023). Endpoints News.
• FDA seeks feedback on ICH E6(R3) GCP guideline (06-06-2023). Regulatory Focus.
• ICH E6 (R3) Good Clinical Practice (26-05-2023). Blog MHRA Inspectorate.
• Q&A: Good clinical practice (GCP) (updated 08-06-2023)
  • D. Records of study subject data relating to clinical trials
    3. What are the considerations when direct remote access of identifiable personal and health data is required in a clinical trial? NEW June 2023

Kunstmatige Intelligentie (KI)

• Interesting reads … May 2023 (10-06-2023. Jan Beger, via LinkedIn.
• Recognizing the Real People Behind the Big Data and Artificial Intelligence in Clinical Research (07-06-2023). ACRP.Association of Clinical Research Professionals (ACRP)
• ChatGPT: standard reporting guidelines for responsible use (06-06-2023). Nature.
• More Than Just a Pretty Face? Nudging and Bias in Chatbots (06-06-2023). Annals of Internal Medicine.
• AI in medicine needs to be carefully deployed to counter bias – and not entrench it (06-06-2023). NPR.
• Who’s Liable for Bad Medical Advice in the Age of ChatGPT? (05-06-2023). Bill of Health.
• Analysis of large-language model versus human performance for genetics questions. Eur J Hum Genet (2023).
• Accelerating the integration of ChatGPT and other large-scale AI models into biomedical research and healthcare. MedComm – Future Med. 2023; 2:e43.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Annual review of good clinical practice referrals (09-06-2023).

National Academies of Sciences, Engineering, and Medicine

• Sponsor Influences on the Quality and Independence of Health Research: Proceedings of a Workshop (2023). Washington, DC: The National Academies Press.

Paediatric investigation plans (PIP)

• Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion – September 2023 (09-06-2023).
• Guidance on paediatric submissions (09-06-2023).

“An improved key elements form, which applicants must use from 12 September 2023, is available …

EMA published the document in June 2023 to help applicants familiarise themselves with the form’s new Word format and the newly added step-by-step guidance within the form.

Applicants should continue using the current PDF form for submissions until 11 September 2023.”

bron: EMA ‘Paediatric investigation plans: Templates, forms and submission dates’

US Food and Drug Administration’s (FDA)

• Final guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry: Guidance for Industry (08-06-2023).
• FDA officials say high priority will be given to applications with endpoints that can be leveraged for other rare diseases (09-06-2023). Regulatory Focus.
• Experts: FDA has legal authority to require greater postmarket safeguards (09-06-2023). Regulatory Focus.
• FDA officials: ‘Significant work’ still needed for rare disease drug development (06-06-2023). Regulatory Focus.

Vereniging Innovatieve Geneesmiddelen

• VIG is back in Boston (06-06-2023).
• Blog Marco Frenken: Onze missie achter de Boston-missie (06-06-2023).

Wellcome

• Report summary: Towards a reformed research and development ecosystem for infectious disease (30-05-2023).

Onderzoek beëindigd? Bedrijf gefuseerd of nieuwe naam gekregen? Organisatie opgeheven? Laat je (oude) domeinnaam niet verlopen!

Overig

• Weekend reads: How a rejected study led to a $3.8 million grant; a ‘nasty’ publishing scheme; the ‘darker side of science’ (10-06-2023). Retraction Watch.
• Journal pulls paper from Ethiopia for unlicensed use of questionnaire (07-06-2023). Retraction Watch.
• Patient Data Return: Do the Benefits Outweigh the Barriers? (07-06-2023). Applied Clinical Trials.
• eCOA IRT eConsent: Simplifying user experience and driving process efficiencies through integration and automation (05-06-2023). Applied Clinical Trials.
• Moral experts as members of ethics commissions as seen through the prism of comprehensive doctrines (10-06-2023). Bioethics.
• Building Capacity for Research Ethics Committees in Uganda (05-06-2023). Journal of Empirical Research on Human Research Ethics.
• Inclusive, engaged, and accountable institutional review boards (05-06-2023). Accountability in Research.
• A researcher who publishes a study every two days reveals the darker side of science (04-06-2023). El Pais.
• Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators (30-05-2023). Frontiers in Medicine.
• Ethicizing history. Bioethical representations of Nazi medicine (29-04-2023). Bioethics.

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