Uitgelicht en gespot op internet (week 15 & 16, 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. Ook zijn de ‘Events‘- en ‘Consultations‘ overzichtspagina’s weer bijgewerkt en voorzien van nieuwe bijeenkomsten en publieke consultaties.
Friendly reminder, 10 mei 2023 – 15:30 – 17:00 (online), EMA CTIS bitesize talk over ‘IMPD-Q only submission’!
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
Belgian Association of Research Ethics Committees (BAREC)
Centrale Commissie Dierproeven (CCD)
Centrale Commissie voor Mensgebonden Onderzoek (CCMO)
Clinical trials
- Decentralised elements in clinical trials: recommendations from the European Medicines Regulatory Network (22-04-2023). The Lancet.
- Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective. Orphanet J Rare Dis 18, 79 (2023).
- Strategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries. Trials 24, 259 (2023).
- Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries. Trials 24, 254 (2023).
- Euro Roundup: Swissmedic updates guidance on combined clinical trials to test drugs, devices (20-04-2023). Regulatory Focus.
- Proefschrift: Healthy elderly in clinical trials: how to define preclinical Alzheimer’s Disease for clinical trial participation (2023). Samantha Prins.
- DCTs a good fit for rare diseases say industry experts (14-04-2023). Clinical Insider.
- US FDA’s definition of trial design “rigor” evolving, study says (11-04-2023). Clinical Insider.
- Successful IRB Submissions Part 2: Common Mistakes Noted During IRB Review (11-04-2023). Learn eCCORE.
- NIH mulls “enforcement actions” for firms that miss trial result publication timelines (03-04-2023). Clinical Insider.
- Specific recommendations to improve the design and conduct of clinical trials. Trials 24, 263 (2023).
- Children and bioethics: clarifying consent and assent in medical and research settings, British Medical Bulletin, Volume 145, Issue 1, March 2023.
- The Rights and Ways for Children to be Involved in Clinical Trial Decisions. DIA Global Forum.
- TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability (20-03-2023). Clinical Leader.
College ter Beoordeling van Geneesmiddelen
Council for International Organizations of Medical Sciences (CIOMS), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
CT-College (College Klinische Proeven) (België)
- Implementation of the CTR, MDR, and IVDR in Belgium (11-04-2023).
- College QC tool for ECs versie d.d. 30/01/2023 (College Audit Tool Ethische Commissies) (gepubliceerd 30-03-2023).
Dutch Oncology Research Platform (DORP)
- DORP biedt onderzoekers statistische ondersteuning (21-04-2023).
- Duurzaamheid in klinische trials (17-04-2023).
Dutch Association of Research Quality Assurance (DARQA)
Dutch Clinical Research Foundation (DCRF)
- Veldnorm Toetsing en Kwaliteitsborging voor WMO-plichtige zorgevaluaties: sneller en gemakkelijker! (19-04-2023).
- Interview: tekort aan research professionals op de werkvloer (19-04-2023).
European CRO Federation (EUCROF)
European Data Protection Board
- Guidelines 8/2022 on identifying a controller or processor’s lead supervisory authority (17-04-2023).
- EDPB adopts final version of Guidelines on data subject rights – right of access (17-04-2023).
- Guidelines 01/2022 on data subject rights – Right of access (17-04-2023).
European Medicines Agency (EMA)
- Single-arm trials as pivotal evidence for the authorisation of medicines in the EU (21-04-2023).
- EMA addresses considerations for single-arm trials (21-04-2023). Regulatory Focus.
- ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products – Step 2b – Scientific guideline (20-04-2023). Legal effective date: 30/09/2023.
Europese Commissie, Horizon 2020, EU funded projects
- Draft Horizon Europe Annotated Grant Agreement, versie 1.0 (01-04-2023).
- FAQ – Frequently Asked Questions
- ERC study identifies repositories that allow researchers to comply with EU open science rules (21-03-2023). European Research Council.
Health-RI
- Denk mee over de nationale gezondheidsdata infrastructuur voor onderzoek en innovatie! (20-04-2023).
Inspectie Gezondheidszorg en Jeugd (IGJ)
- Samenwerkingsprotocol CCMO-IGJ 2023 (20-04-2023).
- Herzien samenwerkingsprotocol CCMO-IGJ gepubliceerd (13 april 2023). Nieuwsbrief voor Goede Onderzoekspraktijken Nr. 168.
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Kunstmatige Intelligentie (KI)
- Acht misvattingen over AI in de zorg (20-04-2023). NTvG.
- The Council of Europe’s Artificial Intelligence Convention: Implications for Health and Patients (18-04-2023). Bill of Health.
Medicines and Healthcare and products Regulatory Agency (MHRA)
- Guidance: Software and Artificial Intelligence (AI) as a Medical Device (06-04-2023).
- Guidance Good clinical practice for clinical trials (updated 06-04-2023). Updated ‘GCP inspection dossier clinical trial spreadsheet’.
- MHRA performance data for assessment of clinical trials and established medicines (14-04-2023).
- Good clinical practice inspection metrics (updated 28-03-2023).
- UK to merge trial regulatory and ethics reviews in study rules overhaul (27-03-2023). Clinical Insider.
Nationaal Comité advies dierproevenbeleid (NCad)
Nationaal expertisecentrum voor wetenschap en samenleving (NEWS)
Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO)
Nieuwsbrief voor Goede Onderzoekspraktijken
NHS Health Research Authority (HRA)
- Help us write guidance to embed public involvement in the design and conduct of clinical trials (31-03-2023).
- Could you help us to support researchers to increase participant diversity in research? (31-03-2023).
- HRA pilots first ever surplus tissue sample tool (30-03-2023).
- The importance of research transparency – a blog by Rebecca Lawrence, Managing Director at F1000, and Catriona Manville, Director of Research Policy at the Association of Medical Research Charities (AMRC) (22-03-2023).
- Making it easier to do clinical trials that everyone can trust (21-03-2023).
- Our analysis of public involvement in clinical trials (21-03-2023).
- Make it Public Week – the first ever week dedicated to research transparency (20-03-2023).
Pharma.be
Secundair datagebruik, Wetsvoorstel elektronische gegevensuitwisseling zorg (Wegiz)
- Eerste Kamer stemt vóór Wetsvoorstel elektronische gegevensuitwisseling in de zorg (18-04-2023). Ministerie van Volksgezondheid, Welzijn en Sport.
- Ook Eerste Kamer stemt unaniem voor Wegiz (18-04-2023). Skipr.
- Kamerbrief over Visie en strategie secundair datagebruik gezondheidszorg (13-04-2023). Ministerie van Volksgezondheid, Welzijn en Sport.
- Beslisnota bij Kamerbrief over Visie en strategie secundair datagebruik gezondheidszorg (28-03-2023). Ministerie van Volksgezondheid, Welzijn en Sport.
- Minister Kuipers breekt vastgelopen debat over data-uitwisseling open (13-04-2023). Dutch Health Club.
- Kamerbrief over landelijk dekkend netwerk infrastructuren (13-04-2023). Ministerie van Volksgezondheid, Welzijn en Sport.
- HealthData@EU Pilot website.
“It will build a pilot version of the European Health Data Space (EHDS) infrastructure for the secondary use of health data “HealthData@EU” which will serve research, innovation, policy making and regulatory purposes. The project will connect data platforms in a network infrastructure and develop services supporting the user journey for research projects using health data from various EU Member States. It will also provide guidelines for data standards, data quality, data security and data transfer to support this cross-border infrastructure. Priority services include a metadata discovery service and a common health data access request. The consortium will collaborate closely with the European Commission and their team working on developing the central services for secondary use of health data. “
Universiteiten van Nederland (UNL)
US Food and Drug Administration’s (FDA)
- Final guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers (12-04-2023).
- NIH mulls “enforcement actions” for firms that miss trial result publication timelines (03-04-2023). Clinical Insider.
- New US guidelines for decentralized and adaptive trials on the way (21-03-2023). Clinical Insider.
- FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy (20-03-2023). Advarra,
- NIH 2023 Data Management and Sharing Policy: What you Need to Know (28-02-2023). Advarra.
- Bioresearch Monitoring Program (BIMO) Compliance Programs (current as of 17-10-2022).
Vereniging Innovatieve Geneesmiddelen
- Jesse Swen: ‘Grote stappen in het DNA-profiel van patiënten’ (18-04-2023).
- Blog Mariska Koster: Paskwil (18-04-2023).
- Proefschrift: ‘Maak gezondheidsinformatie toegankelijker en begrijpelijker’ (18-04-2023).
Overig
- Weekend reads: Harvard group’s work under scrutiny; editorial board resigns en masse; a concussion study hits a brick wall (22-04-2023). Retraction Watch.
- Weekend reads: Plagiarism allegations swirl around superconductor scientist; the ice cream studies no one wants to talk about; when fraud doesn’t pay (15-04-2023). Retraction Watch.
- Weekend reads: Scientist suspended for 13 years; a fraud buster; editor home bias? (08-04-2023). Retraction Watch.
- Xenotransplantation: how close are we?. Nat Biotechnol 41, 452–460 (2023).
- Guidance on research integrity provided by pan-European discipline-specific learned societies: A scoping review, Science and Public Policy, Volume 50, Issue 2, April 2023.
- Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021. JAMA Health Forum. 2023 Mar 3;4(3):e230217.
- FDA draft guidance aims to help sponsors develop drugs for radiation exposure (20-04-2023). Regulatory Focus.
- Global regulators discuss how they are adapting to AI, real-world data in drug and food safety (18-04-2023). Regulatory Focus.
- Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do (14-04-2023). Clinical Leader.
- Food as medicine: translating the evidence. Nat Med 29, 753–754 (2023).
- The therapeutic potential of psychedelics: the European regulatory perspective (04-03-2023). The Lancet.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties