Uitgelicht en gespot op internet (week 5, 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 en Mastodon.

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Accelerating Clinical Trials in the EU (ACT EU), European Medicines Agency (EMA)

• Public consultation on a multi-stakeholder platform to improve clinical trials in the EU (03-02-2023).
• Scientific guideline: Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials – Accelerating Clinical Trials in the European Union (ACT EU) (03-02-2023).

Biosimilar medicines

• Presentations and video recordings – Multistakeholder Event on Biosimilar medicines (13 December 2022) (30-01-2023). European Commission.

Centrale Commissie Mensgebonden Onderzoek (CCMO), Patiëntenparticipatie

• Vanaf 1 maart 2023 patiëntenparticipatie in het onderzoeksdossier (02-02-2023). DCRF.
• CCMO Themapagina ‘Patiëntenparticipatie’
  • Inleiding Programma Patiëntenparticipatie
  • Patiëntenparticipatie in het standaardonderzoeksdossier
  • Vergroten inbreng proefpersonenleden
  • Raad van Proefpersonen

Clinical Research, Clinical Trials

• Kroger Enters Clinical Trials (03-02-2023). Applied Clinical Trials. (Wikipedia: Kroger)
• Boosting Diversity in Oncology Clinical Trials (03-02-2023). Applied Clinical Trials.
• How can we get all clinical trials reported in Germany? (video, highlights and transcript) (31-01-2023). TranspariMED.
• Ethical considerations about the collection of biological samples for genetic analysis in clinical trials (30-01-2023). Research Ethics.
• Don’t Underestimate the Value of the Human Touch in Clinical Trials: Mobile Research Nurses Make a Critical Difference in Decentralized Trials, Whether Employed Exclusively or in Conjunction with Latest Technology (30-01-2023). Applied Clinical Trials.
• Paediatric eye and vision research participation experiences: a systematic review. Trials 24, 66 (2023).
• Mapping the methodological diversity of published drug discontinuation studies—a scoping review of study topics, objectives, and designs. Trials 24, 58 (2023).
• COS-Speech: protocol to develop a core outcome set for dysarthria after stroke for use in clinical practice and research. Trials 24, 57 (2023).
• Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications. Trials 24, 53 (2023).
• Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites. Trials 24, 51 (2023).
• Conditional Power: How Likely Is Trial Success? JAMA. Published online January 23, 2023. doi:10.1001/jama.2022.25080.

Beoordeeld geneesmiddelenonderzoek in Nederland 2012 – 2021, onderverdeeld naar industrie vs. niet-industrie

Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)

• Questions and answers on the protection of commercially confidential information and personal data while using CTIS (31-01-2023). EMA.
• Quick guide for sponsors – Regulation 536/2014 in practice (Eudralex vol. 10) (30-01-2023). European Commission.
  • Experts offer CTIS advice on eve of transition for new applications (30-01-2023). Regulatory Focus.
• Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 December 2022, edition 9) (31-01-2023). EMA.
• EMA wants participants to serve on clinical trial multistakeholder forum (03-02-2023). Regulatory Focus.
• Euro Roundup: EMA shares guidance on CTR, confidential data as new rules take effect (02-02-2023). Regulatory Focus.
• Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU (31-01-2023). EMA.
• Eight Years Later, Europe’s ‘New’ Clinical Trial Rules Finally Come into Force (31-01-2023). Applied Clinical Trials.
• Another milestone reached: CTR (31-01-2023). DCRF.
• CTIS newsflash – 3 February 2023
• CTIS newsflash – 27 January 2023

Dutch Oncology Research Platform (DORP)

• De Toolkit Monitoring is uitgebreid (01-03-2023).

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) 

As of 31 January 2023, all initial clinical trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through the Clinical Trials Information System.

The EudraCT step-by-step guide, the use of the EudraCT database is now limited to:

• the performance of amendments to EU/EEA Clinical Trial Applications for which the initial submission was done before 31 January 2023
• the upload of third country files of trials conducted exclusively outside of the EU/EEA that are part of a Paediatric Investigation Plan (PIP) and/or in scope of Article 46 of the Paediatric Regulation (EC) 1901/2006 (so called “third country files”)
• the update of EudraCT trial statuses by National Competent Authorities
• the submission of results of EudraCT trials by sponsors

Sponsors must transition their trials to CTIS in case:

• their EudraCT trial is going to be conducted in additional EU/EEA member state(s), to which a EudraCT CTA was not submitted before 31 January 2023 (this is considered a new trial application for this member state)
• their EudraCT trial completion date is expected to be after 30 January 2025

In case of a multi-country trial, sponsors should ensure the harmonisation of their clinical trial under the Directive through EudraCT, prior to transitioning their trial to CTIS: see Clinical Trials Regulation Q&A section 11.

bron: EudraCT public home page

European Data Protection Board (EDPB)

• Finnish SA: administrative fine on company for processing health information without an appropriate consent (27-01-2023).

European Federation of Pharmaceutical Industries and Associations (EFPIA)

• EFPIA update on the readiness for mandatory use of the Clinical Trials Regulation (31-01-2023).
• Why Europe must future-proof its pharma legislation (31-01-2023).

EQUATOR Network

• The EQUATOR Network Newsletter – January 2023 (31-01-2023).

International Pandemic Preparedness Secretariat (IPPS)

• Second 100 Day Mission Implementation Report (31-01-2023).

Medicines and Healthcare products Regulatory Agency (MHRA)

• Guidance Completed Paediatric Studies – submission, processing and assessment (01-02-2023).

US Food and Drug Administration (FDA)

• Draft guidance: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (05-02-2023).
  • FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics (02-02-2023). Regulatory Focus.
• Draft guidance: Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (31-01-2023).
  • FDA draft guidance addresses clinical development of drugs to treat early Lyme disease (02-02-2023). Regulatory Focus.
• Draft guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms (31-01-2023).
• Draft guidance: Acromegaly: Developing Drugs for Treatment (30-01-2023).
  • FDA issues draft guidance on developing drugs for acromegaly (31-01-2023). Regulatory Focus.
• OpenFDA Drug Interaction Visualizer Launched (03-02-2023). Applied Clinical Trials.
• 2022 FDA approval number dips: a COVID-19 hangover? (13-01-2023). Nature Reviews Drug Discovery.

ZonMw

• Nieuwe GGG-subsidieronde: Onderzoek met Bestaande data (13-01-2023).

Overig

• Who should take responsibility for integrity in research? (02-02-2023). LSE.
• The effectiveness of implementing statcheck in the peer review process to avoid statistical reporting errors (31-01-2023). PsyArXiv.
• Nonhuman “Authors” and Implications for the Integrity of Scientific Publication and Medical Knowledge. JAMA. Published online January 31, 2023. doi:10.1001/jama.2023.1344
• UKRIO to explore ‘tensions’ on research misconduct in review (27-01-2023). Research Professional News.
• Kuipers verwacht extra alertheid van ziekenhuizen na Isala-zaak (16-01-2023). Skipr.

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