Uitgelicht en gespot op internet (week 50, 2022)

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.

In deze laatste weken van het jaar wordt er nog aardig wat nieuws geproduceerd.

Veel leesplezier!

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn en Mastodon.

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Algemene verordening gegevensbescherming (AVG)

• Lawfulness in secondary use of health data. Interplay between three regulatory frameworks of GDPR, DGA [België]  & EHDS (15-12-2022). Technology Regulation.
• Data protection: Commission starts process to adopt adequacy decision for safe data flows with the US (13-12-2022). European Commission.
• EU-US Data Privacy Framework (z.d.). NoTies Consulting.
• Hoe persoonsgegevens te beschermen als anonimisering niet meer te garanderen is? (13-12-2022). WODC.
• GDPR in cijfers: de jaarverslagen en prioriteiten van de GBA en de AP. Sirius.Legal.

Boeken*

• Boek Noortje Jacobs. ‘Strenge regels voor proefpersonen hebben een roerig verleden’ (07-12-2022). Amazing Erasmus MC.

Of als paperback €43,99

Meer boekenhonger stillen?

Boekenplank *Ik ben een affiliate marketing partner van bol.com en verdien een kleine commissie bij aankopen via de hyperlinks naar bol.com.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Bereikbaarheid CCMO tijdens kerstperiode (13-12-2022).

Clinical trials, Decentralized Clinical Trials, Clinical research, Ethics, Inclusion, Informed consent

• Assessing the acceptability of individual studies that use deception: A systematic review of normative guidance documents (14-12-2022). Accountability in Research.
• Regulators Speak About Decentralized Clinical Trials (14-12-2022). Applied Clinical Trials.
• An early lesson from the Uganda Ebola vaccine trial: Shots must be ready to go before the next outbreak strikes (13-12-2022). STAT.
• How Are DCTs Impacting Your Clinical Sites? (01-12-2022). Life Science Leader.
• The approach to informed consent in acute care research. Lancet Respir Med. 2022;S2213- 2600(22)00408-8.
• Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials. Ther Innov Regul Sci. 2022;1-10.
• Empowering local research ethics review of antibacterial mass administration research. Infect Dis Poverty. 2022;11(1):103.
• When I use a word . . . . Too much healthcare-observational studies. BMJ. 2022;379:o2734. Published 2022 Nov 11.
• Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico-legal position. Dev World Bioeth. 2022.
• The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines. Front Med (Lausanne). 2022;9:966220.
• Distinguishing appropriate from inappropriate conditions on research participation. Bioethics. 2022;10.1111/bioe.13092.
• What matters most to patients with multiple myeloma? A Pan-European patient preference study (29-11-2022). Frontiers in Oncology.
• Acceptable risks of treatments to prevent rheumatoid arthritis among first-degree relatives: demographic and psychological predictors of risk tolerance RMD Open 2022;8:e002593.
• Clinical Research Core Competencies Framework (25-09-2022). Swiss Medical Weekly.

Clinical Trials Coordination and Advisory Group (CTAG)

• Meeting of the Clinical Trials Coordination and Advisory Group (19-10-2022).
  • Survey on CTR implementation: blocking issues, solutions, and the way forward

The EMA informed that major blockers that are preventing the users to work smoothly on CTIS have been identified and that the service providers were committed to solve these blockers before 31 January 2023, date from which the use of CTIS will be compulsory. Member States expressed concerns about CTIS performance and some of the persisting blocking issues, calling for a fully operational system to be delivered on time. The Commission joined this call and encouraged good coordination at national level to ensure that the positions expressed at the EMA management board reflect the Member States needs expressed in this group. The Commission announced that the next steps would consist in identifying the persisting issues, prioritising them and allocating them to the different entities for possible resolution (EMA, Commission, Member States, CTAG, Commission Expert Group on Clinical Trials (CTEG), Clinical Trial Coordination Group (CTCG)). A sub-group of CTAG would be set up to prepare the work of an ad hoc CTAG plenary meeting in December 2022 dedicated to that follow-up.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pag. 2-3.

• • Union Controls

The Commission recalled the concerns expressed by Member States concerning the scope of the Union controls performed in the frame of the CTR. Notwithstanding that Union Controls is a critical method to verify whether Member States correctly supervise compliance with the CTR, the Commission has decided to pause the Union Controls until there is an internal review of the legal provisions. In relation to those Union Controls that had already started, the Commission has been liaising bi-laterally with the concerned Member State to seek agreement as to how to proceed.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pagina 3.

• • Proposals by ES and NL to facilitate clinical trial applications and CTR implementation

ES and NL presented a set of proposals to facilitate clinical trial applications and the CTR implementation. These proposals consisted in rationalising and optimising the work of the different groups involved in the implementation and enforcement of the CTR, updating and complementing guidance materials, developing a kit of first understanding of the CTR (a document summarising the new rules and pointing to the different guidance materials). The Commission welcomed these proposals and indicated that they will be considered, notably in the context of the survey follow-ups. Collaboration with the CTEG and other interested parties will be sought as appropriate.

bron: Meeting of the Clinical Trials Coordination and Advisory Group d.d. 19-10-2022, pagina 3.

Clinical Trials Regulation (CTR)

• Nieuwsbrief CCMO ‘CTR-themanummer’: Eudravigilance | Klokstop CTIS | Symposium CTR | ACT EU | Q&A (15-12-2022). CCMO.
  • Belangrijkste items uit de nieuwsbrief:
    • Eudravigilance: Onder de CTR moeten alle “Suspected Unexpected Serious Adverse Reactions” (SUSAR’s) gemeld worden in Eudravigilance.
    • Klokstop CTIS: Van 22 december 2022 23:59:59 tot 8 januari 2023 00:00:01 is er een winter klokstop in CTIS. Dat betekent dat in die periode alle tijdslijnen bevroren zijn. 
    • Q&A: registratie OMS en actieve stof IMP
• Recommendation paper on decentralised elements in clinical trials, Version 01, 13 December 2022. HMA, European Commission & EMA.

‘Recommendation paper on decentralised elements in clinical trials’ gepubliceerd door EU Directoraat-generaal Gezondheid en Voedselveiligheid

• EMA recommendation paper: Safety, data integrity key to decentralized trial conduct (15-12-2022). Regulatory Focus.
• CTIS Newsflash – 12 December 2022. EMA (via Box.net).
• Veränderungen durch die neue EU-Verordnung 536/2014 zu klinischen Prüfungen aus Patientensicht. Bundesgesundheitsbl (2022).
• Mandatory Use Of ‘Dysfunctional’ EU Clinical Trial Portal Raises Concern In Germany (09-12-2022). Pink Sheet.

Clinical Trials Transformation Initiative (CTTI)

• CTTI Unveils New Recommendations for Embedding Clinical Trials into Clinical Practice (15-12-2022).
• CTTI Recommendations: Embedding Clinical Trial Elements into Clinical Practice (December 2022).

College ter Beoordeling van Geneesmiddelen (CBG)

• CBG schorst vergunningen van aantal generieke medicijnen (14-12-2022).

In de werkwijze van Synchron Research Services zijn tekortkomingen gezien bij bio-equivalentiestudies. Deze studies zijn nodig om de gelijkwaardigheid (bio-equivalentie) van een generiek medicijn met een al eerder goedgekeurd origineel medicijn aan te tonen. Door de tekortkomingen zijn er twijfels over de kwaliteit van de onderzoeken. Fabrikanten moeten nu met nieuwe bio-equivalentiestudies laten zien dat een generiek medicijn hetzelfde effect geeft als het originele medicijn.

bron: CBG nieuwsbericht d.d. 14-12-2022

Commissie Genetische Modificatie (COGEM)

• Aanbiedingsbrief onderzoeksrapport ‘Veerkrachtig biotechnologiebeleid’ (16-12-2022).
• Onderzoeksrapport ‘Veerkrachtig biotechnologiebeleid’ (16-12-2022).

Council for International Organizations of Medical Sciences
(CIOMS)

• CIOMS December 2022 Newsletter (15-12-2022).
• Call for Experts – WHO Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials (08-12-2022). WHO.

Dierexperimenteel onderzoek

• The importance of non-human primates in neuroscience (14-12-2022). Understanding Animal Research.
• Monkey. Understanding Animal Research.
• Wetenschappers pleiten voor betere artikelen over dierproeven. “Volledig publiceren scheelt niet alleen onderzoeksgeld, maar ook onnodig gebruik van dieren” (25-11-2022). Vetscience.

Duchenne Muscular Dystrophy

•  Letter of Support of model-based clinical trial simulation platform (CTSP) for Duchenne Muscular Dystrophy (16-12-2022). EMA.

Dutch Clinical Research Foundation (DCRF)

• Interview “NFU-ervaringen sinds de invoer van de Clinical Trial Regulation” (16-12-2022).
• Terugkijken & slides downloaden: Presentaties en video-link DCRF online-bijeenkomst ondersteunende afdelingen – Lokale uitvoerbaarheidsproces en Verklaring Geschiktheid Onderzoeksinstelling (VGO) 6 december 2022.

Dutch Oncology Research Platform (DORP)

• iFrame Onderzoekbijkanker.nl steeds vaker gebruikt én uitgebreid met filter ‘oncologisch netwerk’ (16-12-2022).

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

The EMA will be closed for public holidays until 03/01/2023 included. All requests submitted to the EudraCT team after 21/12/2022 will be processed from 04/01/2023. This includes Service Now queries, emails to EudraCT_notification@ema.europa.eu and requests for assignments to trials for the purpose of posting results. We thank you for your understanding and we encourage you to refer to the Frequently Asked Questions in the meantime.

bron: EudraCT nieuwsbericht d.d. 15-12-2022.

EudraVigilance

• eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual (updated 15-12-2022). EMA.
• Presentation – eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning – Session 1.0: Introduction (bijgewerkt 13-12-2022). EMA.
• eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training: frequently asked questions (bijgewerkt 13-12-2022). EMA.

European Clinical Research Infrastructure Network (ECRIN)

• Unveiling of ECRIN’s website makeover (14-12-2022).

European Federation of Pharmaceutical Industries and Associations (EFPIA) 

• EFPIA survey among member companies on compliance with the EFPIA-PHRMA principles for responsible clinical trial data sharing (15-12-2022).
• Why aren’t we there yet? The role of partnerships in unleashing patient-centred health data (Guest blog) (13-12-2022).
•  EFPIA response to December EPSCO meeting (09-12-2022).

European Health Data Space (EHDS)

• Initiating an Expert Panel on Data Protection Issues Critical to the Realisation of EHDS (01-12-2022). HealthyCloud.
• Website: European Health Data Space – EHDS HealthDat@EU Pilot 

European Medicines Agency (EMA)

• EMA Management Board: highlights of December 2022 meeting (16-12-2022).

The Agency informed the Board that the system delivers the functionality required for new clinical trial applications which will continue to be developed and enhanced. The Board noted the progress towards further stabilisation of the system in preparation of compulsory use. This stabilisation will improve user experience. The Agency informed the Board about its delivery plan to ensure no blocking technical issues in the core processes by the legal deadline and its commitment to this plan.

The Board welcomed the 2023 CTIS workplan which focusses on enhancing the user experience by implementing improvements in the most impactful functional areas of the system, future proofing and minimising risks to the technical core of CTIS. The Board also agreed to review the current rules on disclosure of certain clinical trial documents and a review of CTIS transparency measures for 2023. As the initiation of this workplan is subject to the stabilisation of the system, the Agency committed to update the Board on a weekly basis on the progress towards stabilisation and full functionality of the system. This update will start on Friday 16 December and stakeholders will be kept regularly informed.

The Agency informed the Board of the various potential risk scenarios and of the development of a business contingency plan.

bron: EMA Management Board: highlights of December 2022 meeting (16-12-2022).

• Big Data highlights – Issue 4 (14-12-2022).
• Human medicines highlights – December 2022 (13-12-2022).
• ICH M12 on drug interaction studies – Scientific guideline (updated 12-12-2022).

FAIR (Findability, Accessibility, Interoperability & Reusability)

• An iterative and interdisciplinary categorisation process towards FAIRer digital resources for sensitive life-sciences data. Sci Rep 12, 20989 (2022).
• New EOSC-Life publication: An iterative and interdisciplinary categorisation process towards FAIRer digital resources for sensitive life-sciences data (07-12-2022). ECRIN.

Good Clinical Practice (GCP)

• EMA webpage: Q&A: Good clinical practice (GCP) (updated 16-12-2022).
  • Question 17. How can sponsors demonstrate oversight for those activities that are delegated by written contract? New December 2022.

Good Lay Summary Practice (GLSP)

• Good Lay Summary Practice, Version 1 (04-10-2022).
  This guidance was developed in cooperation with the Roadmap Initiative to Good Lay. Summary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities (NCA)).
• The Roadmap Initiative to Good Lay Summary Practice.

Inspecties

• Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA (updated 12-12-2022). EMA.

Kunstmatige Intelligentie (KI)

• Terugkijken: ELSI Dialogues – Understanding the Ethics of AI (15-12-2022). BBMRI ERIC via YouTube.

Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)

• Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 2 – December 2022 (15-12-2022).
• MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022 (14-12-2022).
• MDCG 2022-19 – Performance study application/notification documents under Regulation (EU) 2017/746 – December 2022 (12-12-2022).
• Delay to EU MDR is on the horizon (12-12-2022). BioSlice Blog, Arnold & Porter.
• Meeting summary – Third Industry Standing Group (ISG) meeting (15-12-2022). EMA.
  • Presentation – Update on the Expert Panels’ activities (S.da Rocha Dias, M.Antunes, EPG/EMA) (28-11-2022). EMA.
  • Presentation – Update on CTIS and ACT EU (P.Arlett, EMA) (28-11-2022). EMA.

Update on Medical Devices expert panels implementation: EMA presented the status development of the new scientific advice procedure for medical device manufacturers on clinical development strategy and clinical investigation and informed the audience of the launch of a pilot phase for Q1/2023. The pilot is aimed at gathering experience to shape the future scientific advice procedure after 2024. It was highlighted that as part of the pilot phase, the scientific advice will be free of charge. Additional information and guidance will be shared in advance of a dedicated webinar scheduled in January 2023. Medical device industry representatives welcomed the pilot phase.

bron: Meeting summary – Third Industry Standing Group (ISG) meeting (15-12-2022), pag. 3.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Case study: Horizon Scanning Case Study: Guiding principles that can inform the development of Good Machine Learning Practice (14-12-2022).

Methodology, Statistics

• Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?. Trials 23, 987 (2022).
• A concept for causality assessment and causal inference of adverse events cases. Journal of Biological Research – Bollettino Della Società Italiana Di Biologia Sperimentale. 2 November 2022.

Proefschriften

• Jessurun, J. (2022). The role of pharmacy services in improving in-hospital medication safety. [Doctoral Thesis, Erasmus University Rotterdam].

Research Integrity

• Research Integrity and Reproducibility are Two Aspects of the Same Underlying Issue – A Report from STM Week 2022 (14-12-2022). The Scholary Kitchen.
• Cancer researcher banned from federal funding for faking data in nearly 400 images in 16 grant applications (13-12-2022). Retraction Watch.
• PLOS flags nearly 50 papers by controversial French COVID researcher for ethics concerns (13-12-2022). Retraction Watch.
• Self-correction in science: The effect of retraction on the frequency of citations. PLOS ONE 17(12): e0277814.
• Lots of bad science still gets published. Here’s how we can change that. (06-12-2022). Vox.
• Using co-creation methods for research integrity guideline development – How, what, why and when? (06-12-2022). Accountability in Research.

Suïcidepreventie

• ‘Veiligheidsplan helpt om suïcidaal gedrag te bespreken én te voorkomen’ (07-11-2022). ZonMw.
• 113 Suïcide Preventie

TransCelerate Biopharma Inc.

• ICH E8 Landscape Assessment. Results and Analysis from the TransCelerate ICH E8 Member Company Benchmarking Survey (december 2022).

Universiteiten van Nederland, Biotech Booster

• Nettie Buitelaar benoemd tot directeur Biotech Booster (13-12-2022).

US Food and Drug Administration (FDA), Verenigde Staten

• Draft guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (14-12-2022).
• FDA issues draft guidance on pulmonary tuberculosis drugs (16-12-2022). Regulatory Focus.
• FDA revises guidance on responding to ANDA complete response letters (16-12-2022). Regulatory Focus.
• What FDA might consider as delaying or denying an inspection: New guidance spells out the specifics (16-12-2022). Endpoints News.
• Study: Most new antibiotics approved by FDA based on non-inferiority trials with surrogate outcomes (14-12-2022). Regulatory Focus.
• Is my Software a Medical Device? Use the Digital Health Policy Navigator (12-12-2022). FDA Law Blog, Gyman, Phelps & McNamara PC.
• Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH (12-12-2022). Regulatory Focus.

Wet zeggenschap lichaamsmateriaal (Wzl)

• Nog steeds zorgen om juridisch kader (her)gebruik lichaamsmateriaal (16-12-2022). Federatie Medisch Specialisten.
• Brief: Inbreng behandeling Wet zeggenschap lichaamsmateriaal (09-12-2022). NFU, FMS, STZ, COREON, NVVP en Health-RI.

World Health Organization

• WHO to identify pathogens that could cause future outbreaks and pandemics (21-11-2022).
• WHO R&D Blueprint for Epidemics.

Overig

• No one’s quite sure how to fix pulse oximeters. The FDA asked this lab to find answers (16-12-2022). STAT.
• Asking for a Friend: How’s the Investigator Site File Different from the TMF?. Montrium.
• Standaardiseren om te personaliseren (13-12-2022). Amsterdam UMC.
• The rise and fall of peer review (13-12-2022). Experimental History.
• Meer samenwerking nodig om gen- en celtherapieën beschikbaar te krijgen (13-12-2022). Vereniging Innovatieve Geneesmiddelen.
• Duurt het goedkeuren van nieuwe medicijnen tegen kanker te lang? (12-12-2022). Dokter Media.
• From collected stamps to hair locks: ethical and legal implications of testing DNA found on privately owned family artifacts. Hum Genet (2022).
• Enhancing Patient Centricity of Real-World Data Research: An Exploratory Analysis Using the Patient Experience Mapping Toolbox. Value Health. 2022;S1098-3015(22)04684-8.

 

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