Uitgelicht en gespot op internet (week 30 – 36, 2022)

Na een afwezigheid van zes weken ontvangt u hierbij weer een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘. Zoals gebruikelijk ook in deze uitgave een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.

Tevens breng ik onder de aandacht de DCRF Survey Clinical Trials Regulation (CTR). Klik hier om direct naar de survey CTR te gaan.

‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

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Accelerating Clinical Trials in the EU (ACT EU)

• Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan (30-08-2022). EMA.
  • ACT EU multi-annual workplan 2022-2026

The workplan lays out deliverables and timelines. In 2023, they include:

• Large, multinational clinical trials: establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct clinical research
• Implementation of the CTR: a particular focus on Clinical Trial Information System (CTIS) and CTR training activities and trouble-shooting any issues encountered by clinical trial sponsors
• Multi-stakeholder platform: will be established in 2023 to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia, to find practical solutions to enable and drive change
• Modernisation of good clinical practice: ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design
• Facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise key advances in clinical trial methods.

bron: EMA news ‘ACT EU multi-annual workplan 2022-2026’ d.d. 30 augustus 2022.

• Accelerating Clinical Trials in the EU (ACT EU). Delivering an EU clinical trials transformation initiative. HMA, EC, EMA.
• EU adopts 10-part workplan to guide the acceleration of clinical trials (30-08-2022).

EU Decentralised Clinical Trials (EU DCT) project

“Since March 2022, the Clinical Trials Coordination Group (CTCG) is responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project. The EU DCT project is part of the priority actions conducted in the context of the Accelerating Clinical Trials in the EU (ACT EU), which started at the same time as the launch of the Clinical Trials Information System (CTIS) and the implementation of the Clinical Trials Regulation (EU) No 536/2014 (CTR). The DCT project represents a broad collaboration across the European Medicines Regulatory Network with a cross-disciplinary project group including amongst others clinical trial authorisation experts, ethical experts and Good Clinical Practice (GCP) inspectors across Member States. It aims to provide a harmonised and transparent approach for the use of DCT elements in clinical trials. To this end, a Recommendation paper on the use of DCT elements in clinical trials is planned to be published by the end of 2022.”

bron: HMA, Clinical Trials Coordination Group

• ‘The EU Decentralised Clinical Trials project (EU DCT project)’

Advarra (Verenigde Staten)

• Regulatory, Clinical, and Quality Considerations for Device Research (31-08-2022).
• Safe Sharps Handling When Dispensing Investigational Products (31-08-2022).

Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG), WGBO, Data access, Data control, Privacy

• Factsheet Protection of personal data (September 2022). European Court of Human Rights (ECHR).
• Lerend zorgsysteem vraagt om betere beschikbaarheid van gezondheidsgegevens (09-09-2022). Health-RI.
• Bescherming gegeven? Evaluatie UAVG, meldplicht datalekken en de boetebevoegdheid (06-09-2022).
• Wetsevaluatie UAVG aangeboden aan Tweede Kamer (06-09-2022). Hooghiemstra & Partners.
• Data Access, Control, and Privacy Protection in the VODAN-Africa Architecture (18-08-2022). Data Intelligence 2022.
• Trial sector reaching consensus on data anonymization (09-08-2022). Clinical Insider.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Registratie in Eudravigilance ten behoeve van het melden van SUSAR’s in Eudravigilance  d.d. 29 augustus 2022

Clinical trials

• Applied Clinical Trials September 2022 Issue (PDF) (07-09-2022).
• Sites Are Quietly Quitting Your Studies (08-09-2022). Applied Clinical Trials.
• Debunking Top 5 Myths about Digital Twins in Clinical Trials (08-09-2022). Applied Clinical Trials.
• FDA drafts guidance on pediatric clinical pharmacology studies (08-09-2022). RAPS Regulatory Focus.
• Industry experts tout potential for master protocols in pediatric clinical trials (07-09-2022). RAPS Regulatory Focus.
• The Powerful Impact of Caregivers on Clinical Trials (07-09-2022). Applied Clinical Trials.
• The Eradication of False Signals in Monitoring (07-09-2022). Applied Clinical Trials.
• ‘Record’ Gains in Bringing Research Closer to the Patient (07-09-2022). Applied Clinical Trials.
• Patient preference information: Researchers offer insights on medical device clinical trial design (06-09-2022). RAPS Regulatory Focus.
• Outcomes and endpoints in clinical trials supporting the marketing authorisation of treatments in paediatric acute lymphoblastic leukaemia (september 2022). Drug Discovery Today.
• Ethical Criteria for Improved Human Subject Protections in Phase I Healthy Volunteer Trials (01-09-2022). Ethics & Human Research.
• Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds. Front. Oncol. 12:954806.
• Evaluating how clear the questions being investigated in randomised trials are: systematic review of estimands (23-08-2022). BMJ.
• An analysis of published trials found that current use of pragmatic trial labels is uninformative (17-08-2022). Journal of Clinical Epidemiology.
• Master protocol study reporting remains a challenge (09-08-2022). Clinical Insider.
• A New Approach to Simplifying and Harmonizing Cancer Clinical Trials—Standardizing Eligibility Criteria. JAMA Oncol. Published online August 04, 2022.
• Trial designs used during COVID-19 have wider application, say researchers (25-07-2022). Clinical Insider.

Clinical Trials Coordination Group (CTCG), Heads of Medicines Agencies (HMA)

• CTCG Workplan

Clinical Trials Directive (CTD), EudraCT, Transitional  trials, CTR, CTIS

• Sponsors’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated) (24-08-2022). EMA.
• Member states’ guide: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated) (24-08-2022). EMA.
• FAQs: Transition of trials from EudraCT to CTIS – CTIS Training Programme – Module 23 (updated) (24-08-2022). EMA.

Clinical Trials Regulation (CTR)

• Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 July 2022, edition 4) (23-08-2022). EMA.
• EMA reports steady rise in clinical trial applications registered in CTIS portal (23-08-2022). Regulatory Focus.
• Clinical Trials Highlights, issue 10, July 2022 (25-07-2022). EMA.

DCRF survey CTR

Clinical trial results reporting

• De Vito, N. J. (2022). Trial registries for transparency and accountability in clinical research [PhD thesis]. University of Oxford.
• New study flags rampant research waste in Canadian clinical trials (04-09-2022). TranspariMED.
• Guest blog: Regular audit cycles could improve data on European clinical trials (01-09-2022). TranspariMED.
• Guest blog: The potential impact of FDA enforcement on clinical trial reporting (29-08-2022). TranspariMED.
• OIG reprimands NIH for not enforcing trial transparency requirements (18-08-2022). Regulatory Focus.
• Measurement challenges and causes of incomplete results reporting of biomedical animal studies: Results from an interview study (12-08-2022). PLOS ONE.
• Noncompletion and nonpublication of trials studying rare diseases: A cross-sectional analysis. PLoS Med. 2019 Nov 21;16(11):e1002966.

Commissie Genetische Modificatie (COGEM)

• Nieuwsbericht: Advies over maatregelen bij klinische studies met AAV-vectoren en ‘targeted nucleases’ zoals CRISPR-Cas9 (30-08-2022).
• Advies over maatregelen bij klinische studies AAV met ‘targeted nucleases’ d.d. 30 augustus 2022.

Council for International Organizations of Medical Sciences (CIOMS)

• Patient involvement in the development, regulation and safe use of medicines (2022). Report of the CIOMS Working Group XI.

Decentralized Clinical Trials

• Decentralization: An Ethical Obligation (09-09-2022). Applied Clinical Trials.
• “Decentralized Clinical Trials” is Muddled (09-09-2022). Applied Clinical Trials.
• DTRA tearing down the Tower of Babel in decentralised clinical trials (09-09-2022). Clinical Trials Arena.
• Where Does Direct-to-Patient Fit in a Post-COVID World? (08-09-2022). Applied Clinical Trials.
• Medable Selected by GSK to Power Decentralized and Hybrid Clinical Trials (07-09-2022). Applied Clinical Trials.
• New IQVIA Study Demonstrates Cost and Time Savings of Decentralized Trials (07-09-2022). Applied Clinical Trials.
• Decentralized tech speeds enrolment, say researchers (09-08-2022). Clinical Insider.

Diversiteit, Inclusiviteit, Representativiteit

• Clinical Research Needs Greater Participant Diversity (07-09-2022). Applied Clinical Trials.
• Clinical trials: Real-world data plays early role in efforts to increase diversity (05-09-2022). RAPS Regulatory Focus.
• Diversity planning key to making trials more representative, says US CRO group (31-08-2022). Clinical Insider.
• What Should the Goals Be for Diverse Recruitment in Alzheimer Clinical Trials? JAMA Neurol. Published online August 15, 2022.
• Overcoming obstacles in trans and nonbinary participation in clinical trials (29-06-2022). Clinical Trials Arena.

Drug development

• Contemplating a Pressing Drug Development Paradox (07-09-2022). Applied Clinical Trials.
• Building HTA/Payer Perspectives Into Drug Development (04-08-2022). Centre for Innovation in Regulatory Science (CIRS).

Dutch Association of Research Quality Assurance (DARQA)

• DARQA themadag over ”process mapping”, 8 april 2022 (02-08-2022).
• Latest news on OECD Chemical Safety – New reports on good laboratory practice (22-07-2022).
  • No 23: Quality Assurance and GLP
  • No. 24: Position Paper on Quality Improvement Tools and GLP (2022)

Dutch Clinical Research Foundation (DCRF)

• DCRF survey CTR (24-08-2022).

Dutch Oncology Research Platform (DORP)

• Risk based monitoring: een introductie (30-08-2022).
• Onderzoeker en patiënt samen op de weg van klinisch oncologisch onderzoek (27-08-2022).
• Korte video’s om patiënten te informeren over klinisch onderzoek (14-07-2022).

Ethics review

• An Expanded Role for IRBs in the Oversight of Research Biopsies (01-09-2022). Ethics & Human Research.
• Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives (27-08-2022). Current Medical Research and Opinion.
• Boosting ethics review capacity in public health emergency situations: Co-creation of a training model for French-speaking research ethics committees (21-08-2022). Tropical Medicine & International Health.

European Clinical Research Infrastructrure Network (ECRIN)

• Launch of REMEDi4ALL (01-09-2022).

 European CRO Federation (EUCROF)

• Implementing Decentralised Clinical Trials in Italy – Why and How (June 2022).
• How to determine the regulatory pathway for your combination product (June 2022).
• Propositions Paper on Remote SDV/SDR, Version 3 (16-06-2022).

European Federation of Pharmaceutical Industries and Associations (EFPIA)

• EFPIA Position on Transparency of Patient Evidence in Regulatory Decision Making and Product Information.
• Pharmaceutical companies to give evidence on responses to Covid-19 (05-09-2022).

European Medicines Agency (EMA)

• Patient registries: EMA officials highlight opportunities in orphan drug development (25-08-2022). Regulatory Focus.
• Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe. Front. Pharmacol. 13:924648. doi: 10.3389/fphar.2022.924648.

Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)

• Aangepaste toetsmatrijs BROK® en GCP-WMO-examen/ Modified testmatrix BROK® and GCP-WMO-exam (29-08-2022).

Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practices (GCP),

• Updated regulatory and procedural guideline: Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA (31-08-2022). EMA.
• GCP update: advice on what to expect and how to prepare (01-08-2022). Outsourcing-Pharma.com.

Good Publication Practice (GPP)

• Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update (30-08-2022). Annals of Internal Medicine.

Good Automated Manufacturing Practice (GAMP), International Society for Pharmaceutical Engineering (ISPE)

• GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd Edition (July 2022).

Informed consent

• Recruitment interventions for trials involving adults lacking capacity to consent: methodological and ethical considerations for designing Studies Within a Trial (SWATs) (06-09-2022). Trials.
• Informed Consent for Placebo‐Controlled Trials: Do Ethics and Science Conflict? (01-09-2022). Ethics & Human Research.
• Broad Consent—Are We Asking Enough? (01-09-2022). Ethics & Human Research.
• Payments for research participation: Don’t tax the Guinea pig. Clin Trials. 2022 Jul 2:17407745221105896. doi: 10.1177/17407745221105896.

Medical Device Coordination Group (MDCG)

• MDCG 2022-12 – Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) (July 2022).

Methodologie, Statistiek

• Improving Your Statistical Inferences, Daniël Lakens (02-09-2022). (open educational resource).
• Very Short List of Common Pitfalls in Research Design, Data Analysis, and Reporting. PRiMER. 2022;6:26.

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 152 (9 september 2022).

Nederlandse Voedsel- en Warenautoriteit (NVWA)

• NVWA publiceert handboek Voedingssupplementen met tips voor bedrijfsleven (15-08-2022).
  • Handboek Voedingssupplementen, Verrijkte levensmiddelen en Kruidenpreparaten (1.0) (25-08-2022).

Public health research

• “We’re already doing this work”: ethical research with community-based organizations (02-09-2022). BMC Medical Research Methodology.

Rathenau Instituut

• Workshopformat voor onderzoekers over veiligheid in biotechnologie (18-08-2022).

Real World Data (RWD)

• Getting real: who is leading the real-world data charge with clinical trials? (09-09-2022). Clinical Trials Arena.
• De volle potentie van data: gezondheid op maat in een lerend zorgsysteem (06-09-2022). HollandBIO.
• Global digital health leaders propose framework to enhance research using real-world data (29-08-2022). UMC Utrecht.
• Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions (31-08-2022). Nature Communications.

Reporting guidelines

• EQUATOR Network Newsletter July 2022 (28-07-2022).
• Not in the SPIRIT: 2012 checklist had limited impact on reporting (25-07-2022). Clinical Insider.

Research integrity

• Is het einde van dubieuze medische onderzoeken in niet-westerse landen in zicht? (26-08-2022). De Volkskrant.
• How can research institutions support responsible supervision and leadership? (24-08-2022). Accountability in Research.
• Lack of ethics or lack of knowledge? European upper secondary students’ doubts and misconceptions about integrity issues (11-08-2022). International Journal for Educational Integrity.
• Designing and implementing a research integrity promotion plan: Recommendations for research funders. PLOS Biology 20(8): e3001773.
• Recommendations for empowering early career researchers to improve research culture and practice. PLOS Biology 20(7): e3001680.

Trial Master File (TMF), Investigator Site File (ISF), electronic Master File (eTMF), electronic Investigator Site File (eISF)

• Managing Risk When Migrating Your TMF (07-09-2022). Applied Clinical Trials.
• Inspectable & Compliant eTMF Archiving for Closed Studies (07-09-2022). Applied Clinical Trials.
• Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents (18-07-2022). Advarra.

U.S. Food and Drug Administration (FDA), Verenigde Staten

• Newly Added Guidance Documents
  • Draft guidance: General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products (07 september 2022).
  • Draft guidance: E11A Pediatric Extrapolation (26-08-2022).
  • Draft guidance: M12 Drug Interaction Studies (26-08-2022).
  • Draft guidance: Q14 Analytical Procedure Development (26-08-2022).
  • Draft guidance: Q2(R2) Validation of Analytical Procedures (26-08-2022).
  • Draft guidance: Q14 Analytical Procedure Development (26-08-2022).
  • Final guidance: E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers (26-08-2022).
  • Final guidance: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry (27-07-2022).
  • Final guidance: Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for Industry (27-07-2022).
• Guest Post — The Outlook for Data Sharing in Light of the Nelson Memo (06-09-2022). Scholary Kitchen.
• FDA Issues Draft Guidance on Diversity and Inclusion in Clinical Trials (10-08-2022). The National Law Review.

ZonMw

• N=1-trials: wetenschap én betere zorg in één. Interview met Bas Stunnenberg.
• REMEDi4ALL, an ambitious EU-funded research initiative, launches to drive forward the repurposing of medicines in Europe (01-09-2022).
• Drie consortia ontvangen financiering voor acceptatie en implementatie van proefdiervrije modellen in veiligheidsbeoordeling (25-08-2022).

Overig

• Weekend reads: A tale of deception; hydroxychloroquine in Australia; AI and ML to fix your papers — or write them (03-09-2022). Retraction Watch.
• Weekend reads: ‘The Problem of Irreproducible Bioscience Research;’ ‘How to Stop the Unknowing Citation of Retracted Papers;’ data scandal leads to stock drop (27-08-2022). Retraction Watch.
• Didier Raoult papers earn expressions of concern as criminal investigation gets underway (08-09-2022). Retraction Watch.
• Publisher says it will investigate allegations despite editor’s refusal (06-09-2022). Retraction Watch.
• Embryos with DNA from three people develop normally in first safety study (06-09-2022). Nature.
• An editor on why he ignores anonymous whistleblowers – and why authors are free to publish ‘bullshit and fiction’ (28-08-2022). Retraction Watch.

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