Uitgelicht en gespot op internet (week 43 & 44, 2022)
Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Advanced therapy medicinal products (ATMPs) containing genetically modified cells
Algemene verordening gegevensbescherming (AVG), Data sharing, Privacy
- Legislative mistakes in the GDPR (04-11-2022). Jeroen Terstegge, via LinkedIn.
- European Union: Telemedicine stays a national issue? European Council scraps key telemedicine provision in European Health Data Space (03-11-2022). Baker McKenzie.
- Ownership of individual-level health data, data sharing, and data governance (29-10-2022). BMC Medical Ethics.
- Assessment of the Dutch Rules on Health Data in the Light of the GDPR (19-10-2022). European Journal of Health Law.
- Een data-archipel voor veilig gebruik van (medische) persoonsgegevens (19-10-2022). iBestuur.
- The dream of ‘editormetrics’ – Why a FAIR dataset of journal editors would benefit all researchers (18-10-2022). LSE Blog.
- Obstacles removal trajectory. Health-RI.
- A digital mask to safeguard patient privacy (15-09-2022). Nature Medicine.
- Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study (april 2022). eBioMedicine.
Bias
Centrale Commissie Dierproeven
- Harmonisatie beleid genetisch gewijzigde dieren – update (27-10-2022).
- Achterstand publicatie niet-technische samenvatting (NTS) (25-10-2022).
Clinical trials, Clinical research, Decentralized Clinical Trials
- CRO consolidation: is the clinical trials industry reaching a tipping point? (02-11-2022). Clinical Trials Arena.
- Turn Real-World Data Insights Into a Personalized Trial Journey for Every Patient (02-11-2022). Applied Clinical Trials.
- DCT Adoption Tracker: exploring trial decentralisation archetypes by therapy area (03-11-2022). Clinical Trials Arena.
- Navigating Change During Rapid Transformation: A Question-and-Answer Resource for Decentralized Clinical Trials. ACRO.
ACRO answers decentralized trial questions to ease worries and increase uptake (01-11-2022). Outsourcing-Pharma.com. - Central nervous system most researched therapy area for DCTs (01-11-2022). Clinical Trials Arena.
- Decentralized Clinical Trials — Is there a Positive Return on Investment on a Virtual Site? (31-10-2022). Applied Clinical Trials.
- Clinical Trials Design, Scientific Rigor, and Higher-Level Evidence in Surgery (26-10-2022). JAMA Surgery.
- Tech innovations that curb complexity, setting clinical trials up for success (26-10-2022). Clinical Trials Arena.
- Clinical trials and pregnancy (25-10-2022). Communications Medicine.
- Rule changes have negative impact on trials and sponsor-CRO alliances (24-10-2022). Clinical Insider.
- ‘Front of the line’: For Alzheimer’s patients in successful trial, a feeling of gratitude (20-10-2022). STAT.
- How to Make Experimental Treatment Less of a Gamble (14-10-2022). The New York Times.
- Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases (15-09-2022). Trials.
Clinical trial regulation (CTR)
- Scientific recommendations on classification of advanced therapy medicinal products (updated 03-11-2022). EMA.
- Quick guide: Clinical Study Reports submission – CTIS Training Programme – Module 13 (updated 28-10-2022). EMA.
- FAQs: Clinical Study Reports submission – CTIS training programme Module 13 (updated 28-10-2022). EMA.
- Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 September 2022, edition 6) (28-10-2022). EMA.
- Pushing and Dragging the New European Clinical Trials Rules into Shape (26-10-2022). Applied Clinical Trials.
Clinical trial results reporting
- The new European CTIS clinical trial registry: first impressions (01-11-2022). TranspariMED.
- Thousands of patients with “lethal” cancer let down by FDA inaction on clinical trials (31-10-2022). TranspariMED.
- New Zealand: Clinical trials audit finds high reporting rates but slow reporting speeds (25-10-2022). TranspariMED.
- An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials (15-09-2022). Nature Medicine.
College ter Beoordeling van Geneesmiddelen (CBG)
Dutch Association of Research Quality Assurance (DARQA)
Dutch Clinical Research Foundation (DCRF)
- De DCRF volgt een nieuwe koers – een interview met DCRF-bestuurslid Bart Scheerder (29-10-2022).
- Vernieuwde examens GCP-WMO (24-10-2022).
Dutch Oncology Research Platform (DORP), Electronische toestemming, eConsent
Embryowet
- Eerste grote wijziging Embryowet sinds 2002 (17-10-2022).
- Rapport Derde evaluatie Embryowet (28-02-2021)
- Kabinetsreactie op het rapport van de derde evaluatie van de Embryowet van ZonMw (17-10-2022). Minister van Volksgezondheid, Welzijn en Sport.
- Beslisnota bij brief Kabinetsreactie op het rapport van de derde evaluatie van de Embryowet van ZonMw (17-10-2022).
Ethics review
Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)
- Record en Review – examens beschikbaar (03-11-2022).
- EMWO zoekt nieuwe itemconstructeurs (14-10-2022).
FAIR data
Health-RI
Informed consent
Inspectie Gezondheidszorg en Jeugd (IGJ), Medische hulpmiddelen
- Toezicht op gemachtigden van buitenlandse fabrikanten medische hulpmiddelen (04-11-2022).
- Toetsingskader gemachtigden medische hulpmiddelen (04-11-2022).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- ICH releases M11 guideline proposing harmonized template for trial protocols (25-10-2022). Regulatory Focus.
- ICH M11 guideline, clinical study protocol template and technical specifications (26-10-2022). EMA.
- Scientific guideline: ICH M11 technical specification – Step 2b (26-10-2022). EMA.
- Scientific guideline: ICH M11 guideline, clinical study protocol template and technical specifications – Step 2b (26-10-2022). EMA.
- Scientific guideline: ICH M11 template – Step 2b (26-10-2022). EMA.
- The ICH E19 Introductory Training Presentation is now available on the ICH website (25-10-2022).
Medicines and Healthcare products Regulatory Agency (MHRA)
Recruitment, Social media, Virtual recruitment
- Challenges and Possible Solutions to Adapting to Virtual Recruitment: Lessons Learned from a Survey Study during the Covid‐19 Pandemic (01-11-2022). Ethics & Human Research.
- A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial (27-10-2022). Trials.
Sociale media is handig, maar niet achteroverleunen…
- Ineens gaat het online niet over trollen en haat, maar over open standaarden en een zinvol debat (05-11-2022). De Volkskrant.
- As Musk reshapes Twitter, academics ponder taking flight (04-11-2022). Science.
- Mastodon gained 70,000 users after Musk’s Twitter takeover. I joined them (02-11-2022). The Guardian.
Research ethics
- Is Russia’s Research Ethics Culture Reliable? (01-11-2022). Ethics & Human Research.
- Participants’ Perspectives on Payment for Research Participation: A Qualitative Study (01-11-2022). Ethics & Human Research.
- Ethical Frameworks for Disclosure of Alzheimer Disease Biomarkers to Research Participants: Conflicting Norms and a Nuanced Policy (01-11-2022). Ethics & Human Research.
- Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences (13-07-2022). AJOB Neuroscience.
Trial Master File Reference Model (TMF RM)
- The Impact of the EU CTR on the TMF Content and Process (02-11-2022).
- CDISC TMF Plan Template v2 Available (02-11-2022).
US Food and Drug Administration (FDA), National Institutes of Health (NIH)
- Final guidance: M10 Bioanalytical Method Validation and Study Sample Analysis (04-11-2022).
- Final guidance: Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Guidance for Industry (04-11-2022).
- Sponsors need to maintain robust oversight of CROs to avoid FDA enforcement action (03-11-2022). Regulatory Focus.
- Draft guidance. S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals (02-11-2022).
- Draft guidance: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (01-11-2022).
- Draft guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (31-10-2022).
- Draft guidance: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention (27-10-2022).
- Feedback Sought on Strengthening Capacity for Emergency Clinical Trials (28-10-2022). NIH.
- FDA’s multiple endpoints guidance: enough to tackle the growing trial complexity? (28-10-2022). Clinical Trials Arena.
- FDA releases new draft guidances on topical generic drugs (25-10-2022). Regulatory Focus.
- FDA finalizes neurodegenerative disease gene therapy guidance (24-10-2022). Regulatory Focus.
Vereniging Innovatieve Geneesmiddelen
Wet medisch wetenschappelijk onderzoek met mensen (WMO), Vierde evaluatie WMO en CCMO
Wet zeggenschap lichaamsmateriaal (Wzl)
Wetsvoorstel implementatie Open data richtlijn
World Health Organization (WHO)
ZonMw
The Belgian Health Care Knowledge Centre (KCE) and ZonMw invest a maximum of 9 million euros in the third round of their joint program ‘BeNeFIT’.
- Subsidieoproep: Belgium – Netherlands Funding of International Trials 3 (BeNeFIT 3)
- Meld je nu aan voor de workshop over FAIR data stewardship en datamanagement (31-10-2022).
Overig
- Weekend reads, double edition: Science’s ‘nasty Photoshopping problem’; Dr. Oz’s publication ban; image manipulation detection software (05-11-2022). Retraction Watch.
- ICPM 2022: Scientists call for cooperative participation of all partners & patients in R&D of new drugs (02-11-2022). ICPM.
- Guest Post – Wikipedia’s Citations Are Influencing Scholars and Publishers (01-11-2022). The Scholary Kitchen.
- Inconsistent clinical practices thwart wider use of personalized medicine (31-10-2022). STAT.
- SILA: a system for scientific image analysis (31-10-2022). Scientific Reports.
- Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try (25-10-2022). Journal of Law and the Biosciences.
- Nederland koploper in patentaanvragen, tijd om te valoriseren (25-10-2022). HollandBIO.
- It Isn’t Fake Science, Because It Isn’t Science at All. It’s Dupery (25-10-2022). Scholary Kitchen.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties