Uitgelicht en gespot op internet (week 20 & 21, 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.

Het EMA heeft de publieke consultatie geopend voor de ICH E6 (R3) Guideline on good clinical practice (GCP) (Step 2b) geopend. Voor deze en andere publieke consultaties zie ook de ‘Consultations‘-pagina.

Veel leesplezier!

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

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Algemene verordening gegevensbescherming (AVG), Privacy

• A trans-Atlantic comparison of a real struggle: Anonymized, deidentified or aggregated? (23-05-2023). IAPP.
• European decision on the boundary between pseudonymisation and anonymization (16-05-2023). Bristows.
• Joint Guide to ASEAN Model Contractual Clauses and EU Standard Contractual Clauses (24-05-2023).

BBMRI-ERIC

• Newsletter: May 2023

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Wijziging studiegegevens in LTR mogelijk vanaf 15 mei 2023 (15-05-2023).

Clinical Trials Transformation Initiative (CTTI)

• CTTI Recommendations: Increasing Diversity in Clinical Trials
• Diversity Maturity Model for Organizational-Level Strategies

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 (updated 17-05-2023). CTIS Newsflash – 26 May 2023, via Box.com. CTIS newsflash – 12 May 2023 (16-05-2023). CTIS is now a registered data provider for the World Health Organization (WHO). Data from authorised trials published on the CTIS website – excluding those with category 1 deferrals of the main characteristics – is now included in the search portal of WHO’s International Clinical Trials Registry Platform (ICTRP). This applies to relevant clinical trial data, as required by WHO, which has been published on CTIS since the launch of the system on 31 January 2022. … Sponsors are reminded that clinical trials with any type of deferrals and a decision issued after mid-August 2022 are currently not published on the CTIS website. Therefore, these trials will not be included in WHO’s ICTRP. bron: CTIS Newsflash – 26 May 2023, via Box.com.

Data Archiving and Networked Services (DANS)

• Making qualitative data available for reuse? DANS publishes a guidebook with tips. (01-05-2023).

Dutch Oncology Research Platform (DORP)

• Ervaring met DORP: Verbeteren patiënten accrual en opstart studie in andere Europese landen (16-05-2023).
• NKR-gegevens en klinisch onderzoek (12-05-2023).

European Medicines Agency (EMA)

• ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals – step 5 – Revision 4 (updated 22-05-2023)

EMA, ICH M11 guideline, clinical study protocol template and technical specifications

• Overview of comments: Overview of comments received on ICH M11 template (24-05-2023).
• Overview of comments: Overview of comments received on ICH M11 technical specification (24-05-2023).
• Overview of comments: Overview of comments received on ICH M11 guideline, clinical study protocol template and technical specifications (24-05-2023).

Good Clinical Practice (GCP)

• E6(R3): ICH releases draft of overhauled GCP guideline for consultation (25-05-2023). Regulatory Focus.

International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

• IFAPP Today nr. 34 (May 2023).

Kunstmatige Intelligentie (KI)

• Europe’s rulebook for artificial intelligence takes shape (23-05-2023). IAPP.

Medicines and Healthcare products Regulatory Agency (MHRA)

• ICH E6 (R3) Good Clinical Practice (26-05-2023). Blog MHRA Inspectorate.
• MHRA launches public consultation on ICH Good Clinical Practice Guideline which encourages innovation in clinical trials (26-05-2023).
• Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines (26-05-2023).
• MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners (26-05-2023).

Nationaal Comité advies dierproevenbeleid (NCad)

• E-nieuws Nationaal Comité advies dierproevenbeleid (Mei 2023).

NHS Health Research Authority (HRA)

• The future of UK clinical trials – our response to the O’Shaughnessy report (updated 26-05-2023).
• Independent reportCommercial clinical trials in the UK: the Lord O’Shaughnessy review – final report (26-05-2023). GOV.UK.

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 171 (23-05-2023)

Patiëntenparticipatie

• Transforming the health research system: Embedding patient engagement in decision-making. [PhD-Thesis – Research and graduation internal, Vrije Universiteit Amsterdam]. s.n.

Pharma.be

• clinicaltrial.be: een uniek portaal dat patiënten in contact brengt met klinische proeven (24-05-2023).
• België in Europese top 3 klinische studies. Koppositie komt in gevaar (19-05-2023).

US Food and Drug Administration’s (FDA)

• Final guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (26-05-2023).
• Draft guidance: Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products (25-05-2023).
• Final guidance: Study Data Technical Conformance Guide – Technical Specifications Document (24-05-2023).
• Draft guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information (24-05-2023).
  • FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals (24-05-2023). Regulatory Focus.
• Final guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry (24-05-2023).
  • FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies (26-05-2023). Regulatory Focus.
• Draft guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations (17-05-2023).
• Draft guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (17-05-2023).
• Dual draft guidances outline FDA vision for pediatric drug development, exclusivity (19-05-2023). Regulatory Focus.
• FDA officials discuss RWE, don’t endorse a ‘checklist’ approach (22-05-2023). Regulatory Focus.
• Commenters seek clarity in FDA draft guidance on electronic systems, signatures in clinical trials (18-05-2023). Regulatory Focus.

Vereniging Innovatieve Geneesmiddelen

• ‘Goede communicatie essentieel bij klinisch onderzoek’ (23-05-2023).
• Factsheet onderstreept belang van klinisch onderzoek (23-05-2023).
• Blog Marieke Rienks: De wereld van klinisch onderzoek (23-05-2023).

Overig

• Weekend reads: A Nobel winner’s seventh retraction; Stanford’s president fights back; what should go into a retraction notice (28-05-2023). Retraction Watch.
• Three journals’ web domains expired. Then major indexes pointed to hijacked versions (26-05-2023). Retraction Watch.
• Build Quality into Trials Like You’d Build a House, Says FDA’s BIMO Director (22-05-2023). WCG CenterWatch.
• The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team’s experience. Trials 24, 321 (2023).
• Which factors are associated with fraud in medical imaging research? (19-05-2023). European Journal of Radiology.
• Euro Convergence: EMA won’t delay drug approval of combo product if diagnostic part doesn’t have CE mark (18-05-2023). Regulatory Focus.
• Informed Consent and Debriefing When Deceiving Participants: A Systematic Review of Research Ethics Guidelines (15-05-2023). Journal of Empirical Research on Human Research Ethics.
• Observing many researchers using the same data and hypothesis reveals a hidden universe of uncertainty (28-10-2022). PNAS.

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