Uitgelicht en gespot op internet (week 41 & 42, 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‘.

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Advarra

• Modernizing Site Feasibility and Selection (19-10-2022).

Algemene verordening gegevensbescherming (AVG), European Union-U.S. Data Privacy Framework

• Assessment of the Dutch Rules on Health Data in the Light of the GDPR (19-10-2022). European Journal of Health Law.
• Questions & Answers: EU-U.S. Data Privacy Framework (07-10-2022). European Commission.
• Executive Order 14086 of October 7, 2022. Enhancing Safeguards for United States Signals Intelligence Activities (14-10-2022).
• FACT SHEET: President Biden Signs Executive Order to Implement the European Union-U.S. Data Privacy Framework (07-10-2022). The White House.

Applied Clinical Trials

• Applied Clinical Trials October 2022 Issue (PDF) (14-10-2022). Applied Clinical Trials.
• Managing Biospecimens in Cell and Gene Therapy Trials (14-10-2022). Applied Clinical Trials.
• A Biosafety Perspective on Operational Challenges in Cell and Gene Therapy Studies (14-10-2022). Applied Clinical Trials.
• Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular Dystrophy (14-10-2022). Applied Clinical Trials.
• The Risk-Reward Proposition for CGT Clinical Trials (14-10-2022). Applied Clinical Trials.
• A Pervasive Patient Focus in EU Clinical Trials as New Rules Face Fine-Tuning (14-10-2022). Applied Clinical Trials.
• “Culture of Quality” In Action (14-10-2022). Applied Clinical Trials.
• Pharmacovigilance: Literature Monitoring Best Practices (12-10-2022). Applied Clinical Trials.

Association of Clinical Research Organizations (ACRO)

• ACRO Expands Decentralized Clinical Trials Toolkit with Latest Change Management Resource (18-10-2022).

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Tarieven 2023: beoordeling onderzoek onder CTR, MDR en IVDR (20-10-2022).
  • Tarieven beoordeling geneesmiddelenonderzoek en onderzoek naar medische hulpmiddelen
  • Algemene voorwaarden Tarieven CCMO (20-10-2022).

Clinical trial results reporting, Clinical trial registration

• Senators call on NIH to take action on slow-to-report clinical trial sponsors (17-10-2022). Endpoints News.
• Health groups sound alarm over EMA plan to hide clinical trial protocols (17-10-2022). TranspariMED.
• U.S. Senators demand rapid disclosure of all NIH clinical trial results (16-10-2022). TranspariMED.
• New resource: dataset of 736 German ‘unreported’ clinical trials (12-10-2022). TranspariMED.
• Germany: 29% of clinical trials never make their results public (10-10-2022). TranspariMED.
• Trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in New Zealand 1999–2017. BMJ Open 2022;12:e065050.
• Active effort to improve clinical trial data publication ‘remarkably successful’ in some EU countries (04-10-2022). Outsourcing-Pharma.com

Clinical trials – Verenigd Koninkrijk

• Rescuing patient access to industry clinical trials in the UK (20-10-2022). Association of the British Pharmaceutical Industry (ABPI).
• New industry report suggests UK clinical trial research faces ‘existential’ threat (21-10-2022). Endpoints News.
• UK sees decline in clinical trials over last five years, ABPI finds (20-10-2022). Clinical Trials Arena.

Clinical trials, Clinical research

• Assessing and Integrating Patient Preferences into Clinical Research and Care Decisions (oktober 2022). DIA Global Forum.
• Distinguishing appropriate from inappropriate conditions on research participation (21-10-2022). Bioethics.
• Sustainable supply chains: clinical trials in a new era of limited resources (21-10-2022). Clinical Trials Arena.
• Support family caregivers to improve and diversify clinical trials (21-10-2022). STAT.
• Study: Older adults underrepresented in trials of drugs they may regularly use (19-10-2022). Regulatory Focus.
• Clinical trial coordinators sentenced to prison after data falsification scheme (19-10-2022). Endpoints News.
• Sex and science: underrepresentation of women in early-stage clinical trials (17-10-2022). Clinical Trials Arena.
• Experts call for federal incentives to promote clinical trial diversity (10-10-2022). Regulatory Focus.
• Ask the Experts: Protections for Human Trial Participants (10-10-2022). WCG CenterWatch.
• Home Visits Are Trial Participants’ Least-Favored Decentralized Approach (10-10-2022). WCG CenterWatch.
• Episode 19: How Can Clinical Trials Better Reflect Society’s Diversity? (04-10-2022). Issues in Science and Technology.
• Survey Results: GCP Quality and Risks in Decentralized Clinical Trials (19-08-2022). Applied Clinical Trials.
• Improving Access to Cancer Clinical Trials by Reimagining Clinical Trial Conduct (oktober 2022). DIA Global Forum.
• Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey (08-10-2022). Trials.

Data delen

• Onderzoeksdata delen zonder privacyregels te schenden. Open science volgens de regelen der kunst (20-10-2022). Medisch Contact.
• Ensuring the full potential of EHDS: Stakeholders’ recommendations on how to make the digital transformation a success across Europe (20-10-2022). EuropeBIO.
• FORCE11 and COPE Release Recommendations on Data Publishing Ethics for Publishers and Repositories: A Discussion with the Working Group Leadership (20-10-2022). Scholary Kitchen.
  • Puebla, Iratxe, Lowenberg, Daniella, & FORCE11 Research Data Publishing Ethics WG. (2021). Joint FORCE11 & COPE Research Data Publishing Ethics Working Group Recommendations. Zenodo.
• The dream of ‘editormetrics’ – Why a FAIR dataset of journal editors would benefit all researchers (18-10-2022). LSE Impact Blog.
• Guest Post — The Door to Data Sharing is Slowly Creaking Open (17-10-2022). Scholary Kitchen.
• Succesvolle Health-RI conferentie benadrukt urgentie van samenwerken aan een nationale gezondheidsdata-infrastructuur (17-10-2022). Health-RI.
• New EU data quality framework aims to align stakeholders (10-10-2022). Regulatory Focus.
• Global healthcare fairness: We should be sharing more, not less, data (06-10-2022). PLOS Digital Health 1(10): e0000102.
• European Health Data Space: goede intenties, maar… (04-10-2022). iBestuur.

Dutch Oncology Research Platform (DORP)

• Derde werkconferentie Cohorten
• Succesvolle bijeenkomst Patiëntenparticipatie

EFGCP’s Children’s Medicines Working Party (CMWP) 

• Considerations for Adolescent Inclusion in Adult Research: Adolescent Inclusion Decision Tree (06 September 2022 – final version).

The team has developed an open-access ‘Adolescent Inclusion Decision Tree’ for use by trial sponsors, trial investigators, IRBs/ethics committees, and health regulatory agencies, when a trial with age-inclusive trial design is being explored, developed or reviewed. The tool outlines over-arching principles for consideration, and guides users through 5 categories to ascertain the appropriateness of the clinical trial for adolescent inclusion: (1) disease, (2) product, (3) statistical, (4) operational, and (5) legal & ethical.

bron: EFGCP CMWP

ELSI Servicedesk

• ELSI Servicedesk: doorgeefluik én ondersteuner van debat. Interview met Susanne Rebers (oktober 2022). ZonMw.

Embryowet

• Eerste grote wijziging Embryowet sinds 2002 (17-10-2022). Ministerie van Volksgezondheid, Welzijn en Sport.
• 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).

European Clinical Research Infrastructrure Network (ECRIN)

• ERIC Forum Policy Report: Assessing the socio-economic impact of ERICS (12-10-2022).

European Medicines Agency (EMA)

• Newsletter: Clinical Trials Highlights – October 2022 (21-10-2022).
• Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (14-10-2022).
• Updated: Q&A: Good clinical practice (GCP) (10-10-2022).
  • Nieuw toegevoegd: 16. Is the monitoring of bioequivalence clinical trials mandatory?
• High-quality data to empower data-driven medicines regulation in the European Union (10-10-2022).
• Regulatory and procedural guideline: Data Quality Framework for EU medicines regulation (10-10-2022).
• EMA public consultation: iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients (End of consultation (deadlines for comments) 17 November 2022)

International Council for Harmonisation (ICH)

ICH M11 draft Guideline reaches Step 2 of the ICH process (21-10-2022). bron: ICH M11 Template, page 3 This topic was endorsed by the ICH Management Committee in November 2018. This new guideline is proposed to provide comprehensive clinical protocol organisation with standardised content, with: A Template which presents the format and structure of the protocol, including the table of contents, common headers, and contents; A Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content. bron: ICH Multidisciplinary Guidelines M11 EWG Guideline M11 Draft Guideline M11 Template M11 Technical Specification Endorsed documents M11 Concept Paper M11 Business Plan M11 Work Plan

The ICH Q5A(R2) draft guideline [on Viral Safety Evaluation of Biotechnology Products] reaches Step 2 of the ICH process (11-10-2022). ICH advances guidelines on selective reporting of safety data, viral safety (11-10-2022). Regulatory Focus. EMA Adopts ICH E19 Guidelines on Selective Safety Data Collection (10-10-2022). WCG CenterWatch.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Software and AI as a Medical Device Change Programme (17-10-2022).

Medische hulpmiddelen en In-Vitro Diagnostica

• The New Product Liability Directive(s) proposals and medical devices / IVDs (02-10-2022). Medicaldeviceslegal.
• When digital tech becomes a medical device. Many tech companies could soon face a raft of regulatory compliance challenges (z.d.). Deloitte.

Monkeypox

• New UK research consortium to tackle monkeypox outbreak (20-10-2022). Medical Research Council.

Nationaal Comité advies dierproevenbeleid (NCad)

• Nieuw handboek proefdierkunde (11-10-2022).

Netherlands Research Integrity Network (NRIN)

• Newsletter October 2022 (21-10-2022).

US Food and Drug Administration

• Final guidance: Multiple Endpoints in Clinical Trials Guidance for Industry (21-10-2022).
  • FDA finalizes multiple endpoints guidance (20-10-2022). Regulatory Focus.
  • How to avoid false conclusions: FDA finalizes long-awaited guidance on multiple endpoints in clinical trials (20-10-2022). Endpoints News.
• Draft guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (21-10-2022).
• Final guidance: Human Gene Therapy for Neurodegenerative Diseases: Guidance for Industry (21-10-2022).
• Draft guidance: Tissue Agnostic Drug Development in Oncology: Draft Guidance for Industry (17-10-2022).
• Final guidance: Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance for Industry; Availability (17-10-2022).
• Draft guidance: Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability (17-10-2022).
• FDA starts PDUFA VII programs for real-world evidence, innovative trial designs (19-10-2022). Regulatory Focus.
• FDA finalizes guidances on device post-approval studies, postmarket surveillance (10-10-2022). Regulatory Focus.
• FDA Pilot Aims to Help Develop Novel Endpoints for Rare Disease Trials (10-10-2022). WCG CenterWatch.

Wet zeggenschap lichaamsmateriaal (Wzl)

• Brief regering:Nazending bijlage behorende bij de nota naar aanleiding van het verslag inzake Wet zeggenschap lichaamsmateriaal (06-10-2022).
• Bijlage: Overzicht aanvullende werking Wzl

World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) 

• Open consultation: WHO ICTRP guidance for reporting summary results in clinical trial registries (The deadline for submitting feedback is 11 November 2022.)
• Overzicht van de vragen die worden gesteld.

Overig

• Weekend reads: A journal ends accept/reject in peer review; more of a Nobelist’s work comes under scrutiny; CNRS director says what he thinks of sleuths (22-10-2022). Retraction Watch.
• Weekend reads: A bizarre turn in a plagiarism case; lessons of the ‘replication crisis’; special issues redux (15-10-2022). Retraction Watch.
• Paper co-authored by sleuth Elisabeth Bik marked with expression of concern (20-10-2022). Retraction Watch.
• Advancing drug repurposing research: Trends, collaborative networks, innovation and knowledge leaders (december 2022). Drug Discovery Today.
• Research funding is broken. Using a lottery approach could fix it (21-10-2022). STAT.
• She Was Killed by the Police. Why Were Her Bones in a Museum? (19-10-2022). The New York Times Magazine.
• Germ or sex cells: DNA content, research, clinical applications (19-10-2022). The Niche.
• “Selective Hypothesis Reporting in Psychology: Comparing Preregistrations and Corresponding Publications.” MetaArXiv. October 18. doi:10.31222/osf.io/nf6mq.
• How collaboration between bioethicists and neuroscientists can advance research (18-10-2022). Nature Neuroscience.
• Het succes van targeted therapy staat of valt bij goede klinische tests (18-10-2022). Vereniging Innovatieve Geneesmiddelen.
• Nederland: benut het potentieel van nieuwe genomische technieken (18-10-2022). HollandBIO.
• BU lab wasn’t required to clear potentially controversial study with NIH, director says (18-10-2022). STAT.
• Boston University researchers’ testing of lab-made version of Covid virus draws government scrutiny (17-10-2022). STAT.
• Cheating in sports vs. cheating in journalism vs. cheating in science (17-10-2022). Statistical Modeling, Causal Inference, and Social Science.
• Ook onderzoek naar omstreden betalingen aan cardioloog in Rotterdam (18-10-2022). NRC.
• Strafrechtelijk onderzoek naar cardiologen: namen ze miljoenen in steekpenningen aan van een Duitse pacemakerfabrikant? (16-10-2022). NRC.
• Should AI have a role in assessing research quality? (14-10-2022). Nature Index.
• Addressing the Microbiome’s Role in Drug Discovery and Development (oktober 2022). DIA Global Forum.
• Representation Bias In Genomic Research Data Propagates Structural Inequity In Cancer Care (oktober 2022). DIA Global Forum.
• Paediatric biobanking for health: The ethical, legal, and societal landscape. Front. Public Health 10:917615. doi: 10.3389/fpubh.2022.917615.
• The regulation of human blastoid research. A bioethical discussion of the limits of regulation (14-09-2022). EMBO Reports (2022)23:e56045.
• Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy (07-09-2022). Clinical Pharmacology & Therapeutics.
• Patients Need Not Wait: Evolving Compassionate Use and Named Patient Programs Across Asia Pacific (oktober 2022). DIA Global Forum.

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