Nieuwsbrief voor Goede Onderzoekspraktijken

Nr. 172
29 mei 2023

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 29 mei 2023, met het laatste nieuws rond wet- en regelgeving en mensgebonden onderzoek.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

Publieke consultatie draft ICH E6 (R3) Guideline on good clinical practice (GCP) (Step 2b) geopend

Op 26 mei 2023 is de publieke consultatie geopend over de draft ICH E6 (R3) Guideline on good clinical practice (GCP) (Step 2b).

Zoals gebruikelijk bij ICH guidelines: "... stakeholders from ICH Member countries/regions are encouraged to submit their comments to their respective Regulatory Authorities". Voor ons in de EU/EER is dat het European Medicines Agency. Uiterlijk 26 september 2023 moet het commentaar bij het EMA zijn aangeleverd.

"The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2.

While the original E6(R3) Concept Paper stated that before the drafting of Annex 2, its scope would be further clarified, to define the nature of trials involved, in an update to the Concept Paper, the EWG subsequently determined that a separate Concept Paper was preferred for Annex 2. Further to this, an Annex 2 Concept Paper was approved in May 2023 by the ICH MC, and an E6(R3) EWG Annex 2 Sub-group was established to begin development of Annex 2.  

Work on Annex 2 will be progressed in parallel of work on the ICH E6(R3) Principles and Annex 1, with Annex 2 work initiated once the latter reaches ICH Step 2."

bron: ICH Official web site 'Public consultations

Gerelateerd

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

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).

Meer publieke consultaties?

Er zijn weer een aantal nieuwe publieke consultaties toegevoegd aan het overzicht op het weblog.

• Laatste oproep: Input aanleveren voor nieuwe model PIF
• O.a. nieuw toegevoegd: Enquête 'De ontwikkeling, beoordeling en patiënt toegang van cel- en gentherapieën (ATMP’s) in Nederland' (UU, FAST, RSNN)

Overige ontwikkelingen

Centrale Commissie Mensgebonden Onderzoek (CCMO)

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

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).

Nationaal Comité advies dierproevenbeleid (NCad)

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

Patiëntenparticipatie

• Transforming the health research system: Embedding patient engagement in decision-making. [PhD-Thesis – Research and graduation internal, Lidewy Eva Vat, 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).

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).

CTIS nu ook erkend als WHO primary (clinical trials) registry

Het European Medicines Agency (EMA) meldt in de CTIS Newsflash van 26 May 2023 dat het Clinical Trials Information System (CTIS) nu ook is erkend als WHO primary registry.

"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."

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

• CTIS Newsflash – 26 May 2023, via Box.com.
• CTIS newsflash – 12 May 2023 (16-05-2023).

Algemene verordening gegevensbescherming

• 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

Clinical Trials Transformation Initiative (CTTI)

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

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.

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.

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).
• Final guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry (24-05-2023).
• 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).

Eerder verschenen uitgaven van de nieuwsbrief zijn terug te vinden in het archief.