Uitgelicht en gespot op internet (week 50, 51 & 52, 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.

---

Accelerating Clinical Trials in the EU (ACT EU)

• Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 November 2023) (22-12-2023).
• Multi-stakeholder platform Advisory Group: express your interest (12-12-2023).

Association of Clinical Research Professionals (ACRP)

• Increase Efficiency in the Contract Negotiation Process During Study Start-up (20-12-2023).
• Unconventional Care: When Decentralized Research Models and Clinical Patient Management Collide (19-12-2023).
• Data Monitoring and Complex Clinical Trials: Toward a Solution (19-12-2023).

Council for International Organizations of Medical Sciences (CIOMS)

• CIOMS Newsletter, December 2023.

Clinical Trials Transformation Initiative (CTTI)

• Recording of Virtual Public Workshop Now Available: Enhancing Diversity in Clinical Studies (12-12-2023).

Data Archiving and Networked Services (DANS)

• Retrospect on workshop on GDPR issues related to infectious disease research (15-11-2023).

EU Clinical Trials Regulation (CTR), EudraLex, European Commission

• Questions and Answers Document – Regulation (EU) 536/2014, Version 6.7 (21-12-2023).
• Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation, Version 2, December 2023 (21-12-2023).
• Quick guide for sponsors – Regulation 536/2014 in practice, Version 4.0, 8 December 2023 (21-12-2023).

EU Medical Device Regulation (MDR), Medical Device Coordination Group (MDCG)

• MDCG 2023-7 – Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 (21-12-2023).
• MDCG 2021-6 Rev. 1 – Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation, December 2023 (19-12-2023).

European Clinical Research Infrastructure Network (ECRIN)

• ECRIN Newsletter – December 2023 (14-12-2023).

European Medicines Agency (EMA)

• Development and manufacture of human medicinal products specifically designed for phage therapy – Scientific guideline (22-12-2023).
• Letter of support for a composite endpoint method for acceptability evaluation of oral drug formulations in the paediatric population (20-12-2023).
• Regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI) – Scientific guideline (18-12-2023).
• EMA Management Board: highlights of December 2023 meeting (15-12-2023).
• CTIS newsflash – 8 December 2023 (12-12-2023).

ICH Good Clinical Practice (GCP)

• Overview of comments on ICH E6 (R3) guideline (22-12-2023). EMA.

KCE Trials

• 2023/12 – Latest news from KCE Trials: New: KCE Trials Clinical Research Transparency Policy and first monitoring report on transparency practices for KCE Trials funded studies.

Lygature

• The European Lead Factory Final Project Update: Results and Impacts of a Decade of Collaborative Drug Discovery (14-12-2023).

Medicines and Healthcare products Regulatory Agency (MHRA)

• MHRA performance data for assessment of clinical trials and established medicines (15-12-2023).

Regulatory Science Network Netherlands (RSNN)

• RSNN interview series: Thera Max-Mos (13-12-2023).

Stichting Gedragscode Geneesmiddelenreclame (CGR)

• CGR nieuwsbrief nr. 5/2023 Interne transparantie

U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP)

• Pre-Notices for Potential Noncompliance.
• Final guidance: Rare Diseases: Considerations for the Development of Drugs and Biological Products (26-12-2023).
• Final guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (22-12-2023).
• Final guidance: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products (22-12-2023).
• Draft guidance: Master Protocols for Drug and Biological Product Development (21-12-2023).
• Draft guidance: Clinical Pharmacology Considerations for Peptide Drug Products (14-12-2023).
• FDA proposes master control trial guidance that goes beyond COVID-19 (22-12-2023). Regulatory Focus.
• FDA eases informed consent requirements for minimal risk trials (21-12-2023). Regulatory Focus.
• Increasing Options in Clinical Research to Facilitate Medical Product Development (20-12-2023).
• Groups seek changes to FDA’s single-trial effectiveness guidance (19-12-2023). Regulatory Focus.
• NIST drafts differential privacy guidance to enhance individual privacy in research (18-12-2023). Regulatory Focus.
• OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements: Options for How New Sites Added to Ongoing … (15-12-2023).
• Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements (15-12-2023).
• OHRP Determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject … (15-12-2023).
• An adaptive trial design for testing the bioequivalence of generics of highly variable drugs (13-12-2023).

Overig

• Weekend reads: More ‘duplicative language’ in Harvard president’s work; Peru cracks down on misconduct; prison for Macchiarini (23-12-2023). Retraction Watch.
• A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials (23-12-2023). Clinical Trials.
• Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials (23-12-2023). Clinical Trials.
• Netherlands’ research ‘recipe’ makes it a hub for European clinical trials – report (22-12-2023). EURACTIV.
• Therapeutic misunderstandings in modern research (20-12-2023). Bioethics.
• The “3 Ps” of EmPowerment, Partnership and Protection – Stakeholder Perceptions of Beneficial Outcomes of Engagement in HIV Prevention Trials (18-12-2023). Journal of Empirical Research on Human Research Ethics.
• A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model (15-12-2023). PLOS ONE.
• How Re-educating PIs Can Improve Clinical Trial Diversity (15-12-2023). Clinical Leader.
• Patiënten staan open voor meer betrokkenheid bij innovatief wetenschappelijk onderzoek (14-12-2023). TNO.
• How Sponsors and Sites Work Together to Improve Protocol Compliance (14-12-2023). Advarra.
• Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescence in Human Subject Research (11-12-2023). Journal of Empirical Research on Human Research Ethics.
• Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences (11-12-2023). Trials.
• Research involving the recently deceased: ethics questions that must be answered (08-12-2023). Journal of Medical Ethics.
• Current Trends in Biospecimen Management That Are Hindering Your Trials (07-12-2023). Slope.
• Towards achieving transnational research … (06-12-2023). Wellcome Open Research.
• How do trial teams plan for retention during the design stage of the trial? A scoping review (04-12-2023). Trials.