Uitgelicht en gespot op internet (week 3 & 4, 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.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn en Mastodon.
Accelerating Clinical Trials in the EU (ACT EU)
Clinical trials, Research participants
- Oncology clinical trial design planning based on a multistate model that jointly models progression-free and overall survival endpoints (24-01-2023). arXiv:2301.10059.
- The Data and Safety Monitoring Board: The Toughest Job in Clinical Trials (24-01-2023). NEJM.
- COVID-19 looms large amid wider trials slowdown in 2022 says study (20-01-2023). Clinical Insider.
- The impact of different researchers to capture quality of life measures in a dementia randomised controlled trial. Trials 24, 33 (2023).
- Better recognition for research participants: what society should learn from covid-19 BMJ 2023; 380 :e071178.
- Risk-Based Monitoring in Clinical Trials: 2021 Update. Ther Innov Regul Sci (2023).
Clinical Trials Coordination and Advisory Group (CTAG)
- Meeting of the Clinical Trials Coordination and Advisory Group 14-12-2022 (gepubliceerd 19-01-2023).
Clinical Trials Information System (CTIS)
Release notes January 2023
List of known issues and proposed workarounds:
- Clinical Trials Information System (CTIS): online modular training programme (updated 27-01-2023). EMA.
- Sponsors’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated 26-01-2023).
- Member states’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated 26-01-2023).
- FAQs: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated 26-01-2023).
- Clinical Trial Information System (CTIS) evaluation timelines (updated 26-01-2023).
- CTIS newsflash – 20 January 2023 (23-01-2023).
- CTIS newsflash – 13 January 2023 (13-01-2023).
Clinical Trials Regulation (CTR)
- Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications (19-01-2023). EMA.
- Euro Roundup: EMA keeps deadline for CTIS switch, says it can fix ‘blocking bugs’ in time (26-01-2023). Regulatory Focus.
- Presentaties en video-link DCRF webinar Clinical Trials Regulation 17 januari 2023 (24-01-2023).
- EMA confirms sponsors must use new clinical trial information system (20-01-2023). Clinical Insider.
- Nieuwsbrief CCMO ‘CTR-themanummer’: Volledig dossier | Overgangperiode | Herindiening in CTIS | CTIS en OMS | Q&A.
Clinical trials results reporting
- Congress demands that FDA and NIH sanction sponsors that fail to report clinical trial results (20-01-2023). TranspariMED.
- How are pharma companies in Europe doing on clinical trial transparency? (18-01-2023). TranspariMED.
Council for International Organizations of Medical Sciences (CIOMS)
- CIOMS Glossary of ICH terms and definitions, Version 2 (17 January 2023).
- Version 2 newly includes definitions from the following ICH guidelines:
- E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials — Step 4 (final); 27 September 2022
- M11 EWG Clinical electronic Structured Harmonised Protocol (CeSHarP) — Step 2 (draft); 27 September 2022
- Q5A(R2) EWG Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin — Step 2 (draft); 29 September 2022
- Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products — Step 4 (final); 16 November 2022
- M13 EWG Bioequivalence for Immediate-Release Solid Oral Dosage Forms — Step 2 (draft); 20 December 2022
- Version 2 newly includes definitions from the following ICH guidelines:
Dutch Oncology Research Platform (DORP)
- DORP Continues to Connect! (26-01-2023).
- Onderzoeker en patiënt samen op de weg van klinisch oncologisch onderzoek (25-01-2023).
- Succesvolle subsidieaanvragen bij KWF met ondersteuning vanuit DORP (24-01-2023).
- DORP gaat door! (23-01-2023).
EU-X-CT Initiative, EFGCP, EFPIA
- EFGCP and EFPIA launch initiative to enable cross-border access to clinical trials for all patients in Europe (January 2023).
- EU-X-CT Initiative. A multistakeholder initiative jointly led by EFGCP and EFPIA.
EudraVigilance
- EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated 23-01-2023).
- EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated 23-01-2023).
European Medicines Agency (EMA)
- Scientific guideline: Guideline on clinical evaluation of vaccines – Revision 1 (27-01-2023).
- EMA To Focus On Filings For Novel Drugs Under Restart Of Trial Transparency Policy (23-01-2023). Pink Sheet.
European Organisation for Research and Treatment of Cancer (EORTC)
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)
Human Tissue Authority (HRA)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- The ICH Q13 Introductory Training Presentation is now available on the ICH website (26-01-2023).
- The ICH M13A draft Guideline presentation available now on the ICH website (26-01-2023).
- The updated ICH E2B(R3) Q&As reach Step 4 of the ICH Process (23-01-2023).
- ICH M11 Public Webinar – Update on Latest Developments Concerning the ICH M11 Harmonised Guideline and Protocol Template (23-01-2023).
- The ICH Q9(R1) Guideline reaches Step 4 of the ICH Process (20-01-2023).
- Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing (19-01-2023). Regulatory Focus.
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Medical Device Coordination Group (MDCG)
- MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (January 2023).
- Euro Roundup: MDCG issues guidance on in-house devices under MDR and IVDR (12-01-2023). Regulatory Focus.
Medical Device Regulation (MDR)
Nationaal Comité advies dierproevenbeleid (NCad)
NHS Health Research Authority (HRA)
- NHS Digital and NHS England merger – what it means for Confidentiality Advisory Group or Research Ethics Committee approvals (27-01-2023).
- How I got involved in research ethics – a blog by Sue Harrison, Chair of Berkshire B Research Ethics Committee (27-01-2023).
- Putting people first in clinical research – Terry Wogan and moving on from the rhetoric. A blog by Kate Greenwood, Senior Improvement Delivery Manager (27-01-2023).
- Asking new questions of new people – a blog by Becky Purvis, Director of Policy and Partnerships at the HRA ( (26-01-2023).
- 30 years in research ethics – a blog by Stephanie Ellis, Hampstead Research Ethics Committee Chair (23-01-2023).
- Acting on what you’ve told us – a blog by Director of Policy and Partnerships, Becky Purvis (12-01-2023).
Open Access (OA)
Pediatric research
- Incentives in Pediatric Research in Developing Countries: When Are They Too Much? (20-01-2023). Pediatrics.
- Optimizing Clinical Research for Pediatric and Underserved Populations. DIA Global Forum.
Pharma.be
- Forum Clinical Trials – Meerwaarde voor de patiënt (26-01-2023).
- Report to Society – 2022
- Belgium as clinical trial location in Europe Key results for 2021 (18 January 2023). Deloitte.
US Food and Drug Administration (FDA)
- Final guidance: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry (23-01-2023).
- Draft guidance: Mpox: Development of Drugs and Biological Products (19-01-2023).
- Draft Guidance for Industry: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (17-01-2023).
- Federal panel approves plans to safeguard lab-made virus research (27-01-2023). STAT.
- U.S. should expand rules for risky virus research to more pathogens, panel says (20-01-2023). Science.
- Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans (24-01-2023). FDA Law Blog.
- US appropriations Act expands FDA’s trial inspection powers (20-01-2023). Clinical Insider.
- A U.S. judge lectures the government on how academic research works (20-01-2023). Science.
- This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more (20-01-2023). Regulatory Focus.
- FDA details approach for finding optimal dosages for new cancer drugs (17-01-2023). Regulatory Focus.
Wetgeving
- Brief commissie aan bewindspersoon: Verzoek om geconsolideerde wettekst bij de nota van wijziging Wet zeggenschap lichaamsmateriaal (19-01-2023).
- ‘In Spanje is een embryo iets anders dan in Nederland’ (20-12-2022). NEMO Kennislink.
ZonMw
Zorginstituut, #DureGeneesmiddelen #Nuancering #Sluis #PassendeZorg
Overig
- Weekend reads: ‘Against Reviewer 2;’ forced to grant guest authorships; problems in oversight of bat virus research in China (28-01-2023). Retraction Watch.
- Weekend reads: ‘Breakthroughs’ slowing down?; self-publishing among editors; data tampering in space science (21-01-2023). Retraction Watch.
- Autism research at the crossroads (25-01-2023). Deep Dive.
- Studies at patients’ homes may improve accessibility and inclusiveness of drug research (24-01-2023). UU.
- Tools such as ChatGPT threaten transparent science; here are our ground rules for their use (24-01-2023). Nature.
- The Tests Are Vital. But Congress Decided That Regulation Is Not (24-01-2023). ProPublica.
- How do scientists model humanness? A qualitative study of human organoids in biomedical research (March 2023). Social Science & Medicine.
- Time is Money and So Is Effort, Budgeting Experts Say (23-01-2023). WCG CenterWatch.
- Can blockchain help solve the Henrietta Lacks problem? (18-01-2023). Leaps.org.
- Are universities doing enough to address academic misconduct in research? (18-01-2023). University Affairs.
- How to embed ethics into laboratory research (17-01-2023). Accountability in Research.
- Optimal Regulatory and HTA Collaboration in the EU. The New European Union Health Technology Assessment Regulation. DIA Global Forum.
- Rigor Me This: What Are the Basic Criteria for a Rigorous, Transparent, and Reproducible Scientific Study? Front. Cardiovasc. Med., 01 July 2022.
- Preventing fraud in biomedical research. Front. Cardiovasc. Med., 24 August 2022.
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