Uitgelicht en gespot op internet (week 13 & 14, 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.

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Biobank

• Het belang van harmoniseren van biobank procedures (06-04-2023). Health-RI.

Biotechnologie, Genetische modificatie

• Graag wat boeren­verstand voor genetische modificatie (05-04-2023). Medisch Contact.
• Trendanalyse biotechnologie slaat spijker op zijn kop (28-03-2023). HollandBIO.

Clinical Trials Coordination Group (CTCG) Best practice guide naming of documents in CTIS, version 2.0, 9 March 2023 Question and Answers document on CCT and CTIS, vs 1.0, dd 14 March 2023. Clinical Trial Regulation (CTR), Clinical Trials Information System (CTIS) CTIS newsflash – 31 March 2023 (31-03-2023). Questions and answers on the protection of commercially confidential information and personal data while using CTIS (updated 29-03-2023). Key performance indicators (KPIs) to monitor the European clinical trials environment (1-28 February 2023, edition 11) (29-03-2023). EudraLex Bijgewerkte Part II application document templates Compensation for trial participants – Template Version 4, March 2023 | MS Word Site suitability form V2.0 – March 2023 | MS Word Informed consent and patient recruitment procedure template, March 2023 | MS Word

Clinical trials

• Easing the Clinical Trial Technology Burden on Patients and Sites (07-04-2023). Applied Clinical Trials.
• Cannabis, research ethics, and a duty of care (07-04-2023). Research Ethics.
• Research Responsibility Agreement: a tool to support ethical research (07-04-2023). Research Ethics.
• Breaking the mold: How digital endpoints could transform clinical trials (06-04-2023) Clinical Trials Arena.
• How Reverse-Engineering Clinical Trials to Leverage the AI-based-Digital Twin Solution Solves for Many Current Issues, Including Diversity, and Inclusion Shortcomings (05-04-2023). Applied Clinical Trials.
• AD/PD 2023: challenges in clinical trial design for DMTs in PD (05-04-2023). Clinical Trials Arena.
• Long COVID exercise trials proposed by NIH raise alarm (31-03-2023). Nature.
• Electronic health records to capture primary outcome measures: two case studies in HIV prevention research. Trials 24, 244 (2023).
• Listening at Scale and Leveraging Conversational Data to Improve Clinical Recruitment (29-03-2023). Applied Clinical Trials.
• Changing patient preferences toward better trial recruitment: an ethical analysis. Trials 24, 233 (2023).
• The Bridges We Must Build (28-03-2023). Applied Clinical Trials.
• The Role of KRIs in Process-Driven RBQM Success (28-03-2023). Applied Clinical Trials.
• Ethics Along the Continuum of Research Involving Persons with Disorders of Consciousness. Neurocrit Care (2023).
• A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints. Trials 24, 215 (2023).
• Elon Musk’s Neuralink Seeks Surgical Partner for Human Trials, Report Says (27-03-2023). Gizmodo.

Clinical trial results reporting

• New report provides overview of clinical trial transparency laws worldwide (04-04-2023). TranspariMED.
• Incomplete reporting of complex interventions: a call to action for journal editors to review their submission guidelines. Trials 24, 176 (2023).
• Encouraging responsible reporting practices in the Instructions to Authors of neuroscience and physiology journals: There is room to improve. PLOS ONE 18(3): e0283753.

Committee on Publication Ethics (COPE)

• COPE Digest: New publication ethics cases (03-04-2023).

Dutch Oncology Research Platform (DORP)

• Terugblik op de vierde werkconferentie Cohorten (28-03-2023).
• Terugblik DORP Continues to connect (27-03-2023).

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

The “Become a results user” functionality is not working as expected and as described in the relevant instructions. Our IT is working to fix this with high priority. In the meantime, Users requiring the results user role are requested to raise a ticket through http://support.ema.europa.eu/esc, as a workaround so that the role can be assigned ad hoc. We truly apologise for this inconvenience.

Due to essential maintenance, a planned downtime is foreseen for the EudraCT and EU CTR websites on Saturday, April 1st, between 8 am and 6 pm CET. We apologise for this inconvenience and we thank you very much for your patience.

bron: EudraCT public home page d.d. 28-03-2023

European Data Protection Board (EDPB)

• Guidelines 9/2022 on personal data breach notification under GDPR (04-04-2023).

European Federation of Pharmaceutical Industries and Associations (EFPIA)

• Pharmaceutical Legislation: Two things that need to happen now (05-04-2023).

European Medicines Agency (EMA)

• EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other (05-04-2023).
• Scientific guideline: Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (updated 05-04-2023).
• New features further strengthen Priority Medicines scheme (PRIME) (04-04-2023).
  • EMA updates PRIME pathway with roadmaps, scientific advice pilot (04-04-2023). Regulatory Focus.
• DARWIN EU® has completed its first studies and is calling for new data partners (28-03-2023).
  • Interview: EMA’s Peter Arlett reflects on RWE approvals, early learnings from DARWIN (03-04-2023). Regulatory Focus.
• Big Data highlights – Issue 5 (31-03-2023).
• Overzicht van EMA events met betrekking tot Clinical trials (oa. CTR, CTIS).

Human challenge trials

• Disease X: UK releases a blueprint on pandemic human challenge trials (06-04-2023) Clinical Trials Arena.

International Council for Harmonisation (ICH)

• The ICH M7(R2) Guideline reaches Step 4 of the ICH Process (06-04-2023).
• ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk (07-04-2023). Regulatory Focus.
• Generic industry group wants clarity on ICH bioequivalence guideline (06-04-2023). Regulatory Focus.
• ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin – Scientific guideline (updated 27-03-2023). EMA.

Nationaal Comité advies dierproevenbeleid (NCad)

• Advies NCad Menselijk weefsel (06-04-2023). De beschikbaarheid en toegankelijkheid van menselijk weefsel voor biomedisch onderzoek en onderwijs.

Netherlands Code of Conduct for Research Integrity

• How (not) to be held accountable in research: A reply to my critics, Accountability in Research, DOI: 10.1080/08989621.2023.2193694.

N=1 trials

• Proefschrift ‘N-of-1 trials for personalized treatment; the case of muscle channelopathies’ (2023). Stunnenberg, B.C..
• ‘N=1-trials kunnen bewijs leveren voor medicijn bij zeldzame ziektes’ (23-03-2023). Medisch Contact.

Samenwerken met commerciële partijen

• Chantal van Litsenburg: ‘Aan beide kanten vaak koudwatervrees’ (03-04-2023). Vereniging Innovatieve Geneesmiddelen.
• Reactie VIG op opinie KWF: ‘Niet polariseren, maar van elkaar leren’ (28-03-2023). Vereniging Innovatieve Geneesmiddelen.
• Podcast: Samenwerken met commerciële partijen (28-03-2023).

US Food and Drug Administration’s (FDA)

• Draft guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (05-04-2023).
  • FDA issues last guidance in patient-focused drug development series (05-04-2023). Regulatory Focus.
• Draft guidance: Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors (30-03-2023).
  • Guidance details review process for pediatric research not approvable by an IRB (03-04-2023). Regulatory Focus.
• Draft guidance: Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (29-03-2023).
  • FDA releases draft guidance for non-spinal orthopedic bone fixation devices (29-03-2023). Regulatory Focus.
• Final guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff (28-03-2023).
• Study: Half of confirmatory studies for accelerated approvals are late (04-04-2023). Regulatory Focus.
• FDA Backs Randomized Trials for Accelerated Drug Approval (06-04-2023). Applied Clinical Trials.
• FDA encourages RCTs in accelerated approval guidance for oncolog (27-03-2023). Regulatory Focus.
• Special Protocol Assessment Guidance for Industry (06-04-2023).
• Samsung and Sandoz question FDA’s ‘research roadmap’ for biosimilars development (06-04-2023). Endpoints News.
• How to Meet the FDA’s Diversity Guidance (03-04-2023). Applied Clinical Trials.
• Risk Assessment for use of Engineered Genetic Materials in Clinical Research (31-03-2023). Advarra.
• How Single IRB Review Mandates Help Research Sponsors (28-03-2023). Advarra.
• Real-World Evidence (05-04-2023).

Overig

• Guest Post — Why Interoperability Matters for Open Research – And More than Ever (06-04-2023). Scholary Kitchen.
• Diversity in German science: researchers push for missing ethnicity data (05-04-2023). Nature.
• The evolving role of investigative toxicology in the pharmaceutical industry. Nat Rev Drug Discov 22, 317–335 (2023).
• Remote inspections are the new normal, say global regulators (30-03-2023). Regulatory Focus.
• AI ‘fairness’ research held back by lack of diversity (30-03-2023). Nature.
• Het belang van diagnostiek: de zoektocht naar de oorzaak van een zeldzame ziekte (28-03-2023). HollandBIO.
• Protecting the integrity of survey research, PNAS Nexus, Volume 2, Issue 3, March 2023, pgad049.
• The Fraud-Fighting Doc Who’s Busting Corrupt Studies (28-03-2023). Medscape.
  • There is a worrying amount of fraud in medical research (22-02-2023). The Economist.
• Appellate Court Affirms Dismissal of Pacira’s Lawsuit Against ASA and Authors (27-03-2023). American Society of Anesthesiologists.
• How we might stop the flood of data-driven misinformation (23-03-2023). The Washington Post.
• Strategic recommendations from the STARS project to foster academic drug development. Nature Reviews Drug Discovery 22, 251-252 (2023).

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