Nieuwsbrief voor Goede Onderzoekspraktijken

Nr. 174
7 juli 2023

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 7 juli 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.

Vernieuwde look voor ClinicalTrials.gov

Op 21 juni 2023 is de vernieuwde ClinicalTrials.gov online gegaan.

"Informed by user feedback, the modernized website includes an updated look and feel that improves functionality for searching, viewing, and downloading information about clinical trials. The new look includes simple web components that improve navigation and make important information easier to find."

bron: ClinicalTrials.gov Gets a Modernized Look for an Improved User Experience (21-06-2023). NLM.

• ClinicalTrials.gov
• ClinicalTrials.gov (classic website) https://classic.clinicaltrials.gov/

Nieuws uit Nederland

Centre for Human Drug Research (CHDR)

• Bereidheid van patiënten met kanker voor wearables en apps in klinisch onderzoek en zorg – perspectief voor Trial@Home in de Oncologie! (21-06-2023). CHDR.

Dutch Association of Research Quality Assurance (DARQA)

• Summary of ICT theme day on audit trails (review) and data integrity, 31 May 2023 (02-06-2023).
• Verslag DARQA GLP webinar “De analyse van klinische samples: raakvlakken met regelgeving (GLP/GCP/GDPR)”, 12 mei 2023 (25-05-2023).

Dutch Clinical Research Foundation

• DCRF survey Clinical Trial Regulation (20-06-2023).
  • Survey voor toetsende instantie
  • Survey voor verrichter
  • Survey voor deelnemend centrum

Future Affordable Sustainable Therapy Development (FAST)

• Uitgelicht traject: Van off-label naar effectieve en veilige geneesmiddeltherapie voor kinderen (19-06-2023).

Patiëntenparticipatie

• Structurally embedding patient involvement in the health research system: an ongoing quest (25-05-2023). Proefschrift Simone Harmsen.
  • Structurally embedding patient involvement in the health research system.
• Patient involvement in basic rheumatology research at Nijmegen: a three year’s responsive evaluation of added value, pitfalls and conditions for success. BMC Rheumatol 6, 66 (2022).
  • Patiëntenparticipatie bij fundamenteel onderzoek motiveert (jonge) wetenschappers

Trials@Home

• Webinar terugkijken en slides: Trials@Home proof-of-concept study RADIAL is ready for patient recruitment (21-06-2023).

Overig

• The infantilization of the patient (06-07-2023). Life Sciences & Privacy Blog.
  
  • Academische ziekenhuizen schenden medisch beroepsgeheim met verkoop van patiëntendata (29-04-2023). FTM.

Nieuw toegevoegd:

• ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines
• DCRF survey Clinical Trial Regulation

Op 6 juli 2023 zijn de door de Clinical Trials Coordination Group (CTCG) van de Heads of Medicines Agencies (HMA) op 27 juni 2023 aangenomen 'Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014' en de bijbehorende Annex 'Cover letter template' gepubliceerd.

• 'Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014' (Adopted in June 2023.
• Annex: Cover letter template (Adopted in June 2023).

Nieuws van het European Medicines Agency (EMA)

ACT EU

• ACT EU: creating a better environment for clinical trials through collaboration (22-06-2023).

Key performance indicators

• Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 May 2023, edition 14) (23-06-2023).

Presentaties beschikbaar van

• Clinical Trials Information System Webinar: Second Year of Transition (04-07-2023).
• European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting (28-06-2023).
• European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting (27-06-2023).
• Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use  (26/27-06-2023).
• ACT EU multi-stakeholder platform kick-off workshop (22/23-06-2023).

Q&A Good Clinical Practice

• Q&A: Good clinical practice (GCP) (updated 23-06-2023).
  • B.11. According to the applicable EU laws and ICH E6, is it allowed that the sponsor could contract service providers to conduct trial-related tasks, procedures, duties and functions that are under the responsibility of the investigator? Rev. June 2023
  • B.18. What are the expectations for productivity applications used in clinical trials? New June 2023

Real-world evidence

• Use of real-world evidence in regulatory decision making – EMA publishes review of its studies (23-06-2023).

Overig

• Phasing out of extraordinary COVID-19 regulatory flexibilities (06-07-2023).

Een selectie uit het supplement 'Uitgelicht en gespot op internet'

All European Academies (ALLEA)

• ALLEA Publishes 2023 Revised Edition of the European Code of Conduct for Research Integrit (23-06-2023).
• European Code of Conduct for Research Integrity 2023 Revised Edition.

European Health Data Space (TEHDAS)

• The European health data space: Too big to succeed? (september 2023). Health Policy.
• TEHDAS identifies needs for recommendations on cross-border collaboration between health data access bodies (05-07-2023).
• TEHDAS’ proposals for the implementation of EHDS technical infrastructure (04-07-2023).

Nuffield Council on Bioethics

• New blog - 'Keeping up with science: the ethics of synthetic embryos' (03-07-2023).

US Food and Drug Administration’s (FDA)

• Final guidance: Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for Industry (28-06-2023).
  
• Final guidance: Study Data Technical Conformance Guide - Technical Specifications Document (26-06-2023).
• Draft guidance: Psychedelic Drugs: Considerations for Clinical Investigations (23-06-2023).
• Final guidance: Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry (22-06-2023).