Uitgelicht en gespot op internet (week 47, 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.

Vergeet niet om ook regelmatig een kijkje te nemen op de Consultations-pagina (consultations.bontrop.com) en de Events-pagina (events.bontrop.com).

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)

• Accelerating Clinical Trials in the EU (ACT EU): Focus on Decentralized Clinical Trial Innovation (17-11-2022). Medidata.
• ACT EU state of play: EMA’s headway to transform clinical trials (15-11-2022). Clinical Trials Arena.

Algemene verordening gegevensbescherming (AVG), Data Privacy Impact Assessment (DPIA)

• Hoe voer je een Data Privacy Impact Assessment (DPIA) uit? AVHG-Helpdesk voor Zorg, Welzijn en Sport.

Centrale Commissie Dierproeven (CCD)

• Pilot Open by design (22-11-2022).

Clinical trials

• Leading clinical trials companies in the artificial intelligence theme (26-11-2022). Clinical Trials Arena.
• How Clinical Trials Can Thrive in the Digital Era (22-11-2022). Applied Clinical Trials.
• Voices of Women With Lived Experience of Substance Use During Pregnancy: A Qualitative Study of Motivators and Barriers to Recruitment and Retention in Research. Family & Community Health: January/March 2023 – Volume 46 – Issue 1 – p 1-12 doi: 10.1097/FCH.0000000000000349.
• De-risking DCTs with Quality Systems (22-11-2022). Applied Clinical Trials.

Clinical Trials Regulation (CTR)

• Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 October 2022, edition 7) (22-11-2022).

Clinical trials results reporting

• Mega-project will detect missing clinical trial results across five European countries (22-11-2022). TranspariMED.

As of June 2022, 81% of clinical trials are compliant with this requirement in EudraCT.

Between April 2019 and June 2022, the compliance rate rose:

• from 24% to 64% for non-commercial sponsors;
• from 77% to 86% for commercial sponsors.

bron: EMA website ‘Clinical trials in human medicines’

COVID-19

• Guidance for medicine developers and other stakeholders on COVID-19 (updated 21-11-2022). EMA.

Data Analysis and Real-World Interrogation Network (DARWIN EU)

• DARWIN EU® welcomes first data partners (23-11-2022).
• DARWIN EU data partners onboarded in phase I (23-11-2022).
• IKNL datapartner in Darwin EU®-netwerk van het European Medicines Agency (24-11-2022). IKNL.
  • Observational Health Data Sciences and Informatics (OHDSI)
  •  Standardized Data: The OMOP (Observational Medical Outcomes Partnership) Common Data Model

DARWIN EU collaborates with data partners who help generate real-world evidence that can be used in scientific evaluations and regulatory decision-making. The data partners enable DARWIN EU to use their data in its scientific studies, and provide analysis results to the DARWIN EU coordination centre, in accordance with data protection rules.

bron: EMA website ‘Data Analysis and Real World Interrogation Network (DARWIN EU)’

Data reuse

• A Wolf in Sheep’s Clothing: Reuse of Routinely Obtained Laboratory Data in Research (18-11-2022). J Med Internet Res.

Decentralized Trials & Research Alliance (DTRA)

• DTRA points to regulations, infrastructure, and tech as keys to DCT growth (21-11-2022). Clinical Insider.

Dierexperimenteel onderzoek

• Advanced Non-animal Models in Biomedical Research, EUR 30334/6 EN, Publications Office of the European Union, Luxembourg, 2022, ISBN 978-92-76-58965-5, doi:10.2760/604397, JRC131505.

Dutch Association of Research Quality Assurance (DARQA)

• Verslag DARQA GMP-themadag “GMP aspecten rond Insourcing/outsourcing; producties naar Europa krijgen”, 18 november 2022 (26-11-2022).

Dutch Oncology Research Platform (DORP)

• Opstarten klinische studie in het buitenland (21-11-2022).
• Terugblik eConsent Webinar (21-11-2022).

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

What’s New: From 31 January 2023, sponsors will need to use the Clinical Trials Information System to apply for authorisation of a new clinical trial in the EU/EEA. From this date onwards, EudraCT will no longer allow the creation of new EU/EEA Clinical Trial Application (CTA) for the purpose of submission to National Competent Authorities (NCAs), including creation of CTA(s) in order to add member state(s) to an existing EudraCT trial. See section 11 of the Q&A on Regulation (EU) 536/2014.

EudraCT will remain available to sponsors for: amendments of CTAs that were submitted to NCAs before January 31st, 2023; creation and uploading of PIP/Art 46 trials conducted exclusively in third countries (see FAQs); results submission for all EudraCT trials.

22-11-2022: Sponsors of clinical trials on COVID-19 are reminded to include the term “COVID-19” in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants. In addition, we encourage sponsors of COVID-19 trials to post the relevant results as soon as it is feasible, also before the deadline.

14-11-2022: Users have reported issues with uploading CTA XML files on EudraCT. Our IT is currently working on this, we thank you very much for your understanding and patience. Update 21Nov2022: this issue is now solved.

bron: EudraCT public home page

European Medicines Agency (EMA)

• EMA offers insights on when biologics qualify as new active substances (21-11-2022). Regulatory Focus.

Good Clinical Practice (GCP), European Medicines Agency (EMA)

• EMA: Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021 (21-11-2022 gepubliceerd).

Good Clinical Trials Collaborative

• The Good Clinical Trials Collaborative.
  The Good Clinical Trials Collaborative is a global community initiative that has developed new guidance to promote and enable good randomized controlled trials.

Health Products Regulatory Authority (HPRA) (Ierland)

• MDR and IVDR regulatory information published by the HPRA (23-11-2022).

Health-RI

• Health-RI major partner in European Commission’s Genomic Data Infrastructure project (17-11-2022).

International Coalition of Medicines Regulatory Authorities (ICMRA)

• Best practices to fight antimicrobial resistance (21-11-2022). EMA.
• ICMRA report on AMR best practices (November 2022)

International Council for Harmonisation (ICH)

• ICH touts adoption of continuous manufacturing, safety reporting guidelines (22-11-2022). Regulatory Focus.

Kunstmatige Intelligentie

• Artificial intelligence in European medicines regulation (21-11-2022). Nature Reviews Drug Discovery.

Methodology, Statistics

• High-dimensional propensity scores for empirical covariate selection in secondary database studies: Planning, implementation, and reporting (08-11-2022). Pharmacoepidemiology and Drug Safety.
• Transparency of high-dimensional propensity score analyses: Guidance for diagnostics and reporting (29-01-2022). Pharmacoepidemiology and Drug Safety.

Nationaal Comité advies dierproevenbeleid (NCad)

• E-nieuws Nationaal Comité advies dierproevenbeleid
  • Nieuwe samenstelling NCad
  • Uit EARA News: veel te weinig fondsen voor het goedkeuren van diervrije methoden
  • Symposium over Next level non-animal testing 2 december
  • Biotechnische dagen 7 & 8 december
  • Workshops over ongeriefinschatting en verfijning 25 en 26 januari

NHS Health Research Authority (HRA)

• Access all areas? – a blog by Lou Silver, Equality Diversity and Inclusion Manager Health Research Authority (23-11-2022).
• Health Data Research UK joins public involvement pledge (15-11-2022).
• Indemnity cover for NHS staff delivering research (20-10-2022).

Orphan medicinal products, Weesgeneesmiddelen

• Commission Notice Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (2022/C 440/02) (21-11-2022). Official Journal of the European Union.
• Weesgeneesmiddelen, een routekaart  voor de toekomst. Vereniging Innovatieve Geneesmiddelen.

Pharma.be

• Farmaceutische bedrijven en patiëntenorganisaties ontmoeten elkaar (21-11-2022).
• Innovatieve geneesmiddelen vergen innovatieve regelgeving (21-11-2022).

QT prolongation, Thorough QT/QTc (TQT) study

• A novel approach to cost effective Thorough QT studies utilizing a highly automated Hybrid Phase I/ECG Core Laboratory. Celerion.

Regulatory Science Network Netherlands (RSNN)

• 2022 RSNN Annual Workshop Report available now (22-11-2022).
  • RSNN Annual Workshop Report.

Research ethics, Research integrity, Misconduct

• Ook tien jaar na de fraude duikt het sjoemelonderzoek van Diederik Stapel nog steeds op (25-11-2022). De Volkskrant.
• ‘But how will you ensure the objectivity of the researcher?’ Guidelines to address possible misconceptions about the ethical imperatives of community-based research (22-11-2022). Research Ethics.
• UK at a ‘key moment’ for research integrity (22-11-2022). *Research Professional.
• Just how important is the problem of predatory publishing? (21-11-2022). LSE.
• Research integrity guidelines in the academic environment: The context of Brazilian institutions with retracted publications in health and life sciences (28-10-2022). Front. Res. Metr. Anal. 7:991836. doi: 10.3389/frma.2022.991836.
• A Rough Guide to Spotting Bad Science (02-04-2014). Compound Interest.

Retraction Watch Database

• The Retraction Watch Database

Simultaneous National Scientific Advice (SNSA)

• Launch of phase 2 of the simultaneous national scientific advice pilot (22-11-2022). HMA.
• Simultaneous National Scientific Advice (SNSA). HMA.
• Accelerating Clinical Trials in the EU (ACT EU) (22-11-2022). EMA

In November 2022, the EU Innovation Network launched the second phase of the simultaneous national scientific advice (SNSA) pilot. SNSA is intended for situations where an applicant wishes to obtain scientific advice from more than one national competent authority (NCA) at the same time. This is meant to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicine Agencies (HMA), the second phase of the SNSA pilot will run for a two-year period until the end of 2024. It incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.

bron: EMA website ‘Innovation in medicines’

• Guidance for applicants on simultaneous national scientific advice (SNSA) briefing book format and content (22-11-2022).
• Guidance for applicants on simultaneous national scientific advice (SNSA) phase 2 pilot (from October 2022) – Optimised process (22-11-2022).
• Application form to request a simultaneous national sientific advice (SNSA) (22-11-2022).
• Science advice on medicines for Human use in the EU medicines regulatory network (22-11-2022).
• List of NCA’s participating in the simultaneous national scientific advice (SNSA) pilot phase 2 (22-11-2022).
• België – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
  • Simultaneous national scientific advice pilot project: launch of phase 2 (23-11-2022). FAGG.
    • Simultaneous national scientific advice (SNSA) pilot project: launch of phase 2 (22-11-2022). FAGG.

US Food and Drug Administration (FDA), HIPAA Privacy and Security Rules, Verenigde Staten

• Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies (25-11-2022). FDA.
• Privacy and Security — Protecting Patients’ Health Information (24-11-2022). NEJM.

Vereniging Innovatieve Geneesmiddelen

• ‘Maak klinisch onderzoek bespreekbaar voor patiënt én samenleving’ (22-11-2022).
• Feiten en frames: op naar een vruchtbare samenwerking tussen academie en industrie (22-11-2022).
• Doorpakken nodig voor ‘Nederland als medicijnhub’ (22-11-2022).

Wet zeggenschap lichaamsmateriaal (Wzl)

• Brief regering: Reactie op verzoek commissie over hoe het wetsvoorstel actualisering lichaamsmateriaalwetgeving zich verhoudt tot de wet zeggenschap lichaamsmateriaal en de Europese verordening lichaamsmateriaal (22-11-2022). Minister van Volksgezondheid, Welzijn en Sport.

• Brief regering d.d. 06-10-2022, Minister van Binnenlandse Zaken en Koninkrijksrelaties.
• Bijlage bij brief regering: Overzicht aanvullende werking Wzl (06-10-2022).

ZonMw, Hergebruik data, Findable, Accessible, Interoperable and Reusable (FAIR)

• Zijn onze data klaar voor de toekomst? Het FAIR maken van data in projecten over antimicrobiële resistentie en infectieziekten.
• RIVM vaccinatiedata en GGD testdata worden toegankelijk gemaakt voor oversterfte onderzoek via CBS (24-10-2022).
• Aandacht voor gender en sekse in onderzoek blijft nodig (22-10-2022).

Overig

• Weekend reads: What should happen to a paper by Theranos?; Diederik Stapel continues to be cited; a scientist accused of hiding China ties wins $2 million (26-11-2022). Retraction Watch.
• Big Pharma’s Twitter exodus; Merck wagers $1.35B on buyout; $3.5M gene therapy; and more (26-11-2022). Endpoints News.
• Biggest drug companies halted Twitter ad buys after Lilly insulin spoof (21-11-2022). Endpoints News.
• Rathenau: veiligheid biotechnologieonderzoek gewaarborgd, maar overheid moet kennis vergroten (22-11-2022). HollandBIO.
• Science in motion: A qualitative analysis of journalists’ use and perception of preprints. PLOS ONE 17(11): e0277769.
• Mapping the content of comments on bioRxiv and medRxiv preprints (24-11-2022). bioRxiv 2022.11.23.517621.
• External Comparator Groups Derived from Real-world Data Used in Support of Regulatory Decision Making: Use Cases and Challenges. Curr Epidemiol Rep (2022).
• Gene name errors: Lessons not learned. PLOS Computational Biology 17(7): e1008984.

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