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.
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Algemene verordening gegevensbescherming (AVG), Privacy
- EU General Court examines data anonymisation and pseudonymisation. JDSupra.
- Is anonimiseren makkelijker dan gedacht? (30-05-2023). ICTRecht.
Clinical trials, Clinical research
- UK should aim for 60-day trial approvals says review author (30-05-2023). Clinical Insider.
- NIH toughens enforcement of delayed clinical trials reporting (26-05-2023). Science.
- Published registered reports are rare, limited to one journal group, and inadequate for randomized controlled trials in the clinical field (26-05-2023). Journal of Clinical Epidemiology.
- CROs that foster an inclusive culture make clinical trials more diverse (22-05-2023). Clinical Insider.
- Issues with Ethics in Research – A Case Study of the IHU Mediterranee Infection. OSF Preprints, 11 Jan. 2023.
- Age Diversity In Clinical Trials: Why It Matters (02-06-2023). Clinical Leader.
- Considerations For Compliance With CTIS Submissions Under The EU-CTR (01-06-2023). Clinical Leader.
- Rethinking ECOG Scores to Improve Patient Access and Clinical Trials Eligibility (31-05-2023). Applied Clinical Trials.
- Is patient centricity the answer to the perpetual enrolment gap that plagues trials? (31-05-2023). Clinical Trials Arena.
- Barriers and facilitators to the inclusion of deaf people in clinical trials (27-05-2023). Clinical Trials.
- Performance of Cox regression models for composite time-to-event endpoints with component-wise censoring in randomized trials (27-05-2023). Clinical Trials.
- An example of implementing a safety protocol in remote intervention and survey research with college students (27-05-2023). Clinical Trials.
- What If We Could Do Clinical Trials Before We Do Clinical Trials? (27-05-2023). Clinical Leader.
|Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)|
DIA Global Forum
- DIA Global Forum – Driving Insights to Action (June 2023).
European Animal Research Association
- Threat to all biomedical research in EU phase-out petition (29-05-2023).
- EARA feature – Animals in cancer studies (29-05-2023).
European Clinical Research Infrastructure Network (ECRIN)
European Medicines Agency (EMA)
“EMA and the Heads of Medicines Agencies (HMA) are running a pilot project to enable clinical-oncology scientists to participate in medicine regulation. The pilot aims to achieve this by providing them with an understanding of basic principles relevant to their field.
The pilot focuses on scientific advice and marketing authorisation assessments for human medicines.
Prospective candidates must have experience in clinical oncology or haemato-oncology.
They do not need to have any prior understanding of regulatory requirements in medicine evaluation.
The pilot consists of live and recorded webinars covering the following areas:
Basic principles of the regulation of human medicines in the EU
Basic regulatory aspects relevant to oncology
Prospective candidates can apply by completing a brief registration form.
Participation is free of charge.
EMA and HMA launched the pilot in May 2023. It will be rolled out over 12 months.
It aims to increase collaboration between regulatory authorities and stakeholders in healthcare and academia, in line with the recommendations of the STARS common strategy.”
bron: EMA ‘Academia’
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)
- Save the date: infosessie voor sponsors over vroege fase klinische proeven op 15 september 2023 (30-05-2023).
- Presentaties en de geluidsopnames beschikbaar: Information session on CTR for stakeholders op 10 maart 2023.
- Introduction (Hugues Malonnes & Nele Steens) (PDF – video)
- Overview of numbers in Belgium (and in Europe) for CTR (Hans Vincke) (PDF – video)
- Regulatory aspects of the implementation of CTR and work in CTIS: updates and clarifications, tips for a smooth validation (Anne Lenaers) (PDF – video)
- Transformation of the clinical trial landscape at European level: state of play and future initiatives (Greet Musch) (PDF – video)
- Safety cooperation and work-sharing among Member States (Elena Prokofyeva) (PDF – video)
- CT-College: missions and achievements (Katelijne Anciaux) (PDF – video)
- How Belgian medical ethics committees review clinical trials: analysis of recurrent questions in ethics reviews of pilot CTR submissions and lessons learned (Audrey Van Scharen) (PDF – video)
- First experiences in CTR – perspective of commercial sponsor (Susan Tio) (PDF – video)
- First experiences in CTR – perspective of CRO (Tom Van Paepegem & Sara Weytjens) (PDF – video)
- First experiences in CTR – learnings from a case study (Vanessa Parrein) (PDF – video)
- Q&A session (video)
Findable, Accessible, Interoperable and Reusable (FAIR)
- The FAIR Cookbook – the essential resource for and by FAIR doers. Sci Data 10, 292 (2023).
- FAIR in action – a flexible framework to guide FAIRification. Sci Data 10, 291 (2023).
Kunstmatige Intelligentie (KI)
- National Artificial Intelligence Research and Development Strategic Plan 2023 Update (May 2023). OSTP.
- Generating Harm: Generative AI’s Impact and Paths Forward (May 2023). EPIC.
- What is ‘ethical AI’ and how can companies achieve it? (26-05-2023). The Conversation.
- How Generative AI May Transform Content Development in the Life Sciences. DIA Global Forum.
Medicines and Healthcare products Regulatory Agency (MHRA)
- MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines (25-05-2023).
Nieuwsbrief voor Goede Onderzoekspraktijken
Towards the European Health Data Space (TEHDAS)
UK Research Integrity Office (UKRIO)
US Food and Drug Administration’s (FDA)
- Rare Disease Endpoint Advancement Pilot Program (RDEA).
- Final guidance: Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry (22-06-2023).
- Final guidance: Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals (05-06-2023).
- Draft guidance: Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry (02-06-2023).
- Draft guidance: Migraine: Developing Drugs for Preventive Treatment (01-06-2023).
- Accelerated approval trials: Commenters seek details on single-arm considerations (01-06-2023). Regulatory Focus.
- FDA considers new efficacy endpoint for diabetes drugs (31-05-2023). Regulatory Focus.
- FDA finalizes guidance on adjusting for covariates in randomized trials (30-05-2023). Regulatory Focus.
World Health Organization (WHO)
- Weekend reads: How university rankings lead to bad science; how to report research misconduct; the impact of Retraction Watch reporting (03-06-2023). Retraction Watch.
- Verlopen domeinnamen van wetenschappelijke tijdschriften kunnen een goudmijn zijn (31-05-2023). NRC.
- Concordance of International Regulation of Pediatric Health Research (26-05-2023). The Journal of Pediatrics.
- HIPAA is a misunderstood and inadequate tool for protecting medical data. Nat Med (2023).
- Public Attitudes for Genomic Policy Brief: return of research results (23-05-2023). GA4GH.
- Ontologizing health systems data at scale: making translational discovery a reality. npj Digit. Med. 6, 89 (2023).
- A Content Analysis of HIV-Related Stigmatizing Language in the Scientific Literature, From 2010-2020: Findings and Recommendations for Editorial Policy (10-05-2023). Health Communication.
- How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development. Trials 24, 345 (2023).
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