Uitgelicht en gespot op internet (week 4, 2022)
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘ met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Vergeet niet om ook de ‘Events‘ pagina (events.bontrop.com) en de ‘Consultations‘-pagina (consulations.bontrop.com) te raadplegen.
‘Uitgelicht en gespot op internet’ is een supplement van de Nieuwsbrief voor Goede Onderzoekspraktijken.
Algemene verordening gegevensbescherming (AVG), Privacy
Artificial intelligence, Prediction models
- Guidelines and quality criteria for artificial intelligence-based prediction models in healthcare: a scoping review (10-01-2022). npj Digital Medicine.
- AI Roadmap Methodology and findings report (januari 2022). NHS Health Education England (HEE) and Unity Insights.
Associatie van Contract Research Organisaties in Nederland (ACRON)
Audits
- Can we use GCP / PV audits as an inspection exercise? (27-01-2022). Beyond Compliance, via LinkedIn.
Clinical research, Clinical trials, Decentralized trials (DCTs)
- Single-arm clinical trials that supported FDA Accelerated Approvals have modest effect sizes and at high risk of bias (27-01-2022). Journal of Clinical Epidemiology.
- Challenges in the Design, Registration, and Reporting of Noninferiority Trials. JAMA Psychiatry. Published online January 26, 2022.
- They built a smarter approach to Covid clinical trials. Now they want to do the same for other diseases (24-01-2022). STAT.
- Analysis: DCTs Are Proving Their Benefits, Significantly Cutting Down Trial Costs (24-01-2022). WCG CenterWatch.
- COVID Is Changing the Dynamics of Medical Research and Publishing — Hasty studies and neglect of other health issues should make us question the current approach (22-01-2022). Medpage Today.
Clinical Trials Regulation (CTR)
- Centrale Commissie Mensgebonden Onderzoek
- Geneesmiddelenonderzoek (CTR), informatie voor onderzoekers in het Nederlands.
- Model naleving regels dataprotectie/template (personal) data, version 13 January 2022. Compliance with Member State applicable rules for the collection, storage and future use of (personal) data (article 7 (1 d) of EU Regulation 536/2014).
- European Medicines Agency (EMA)
- Newsletter: Clinical Trials Information System (CTIS) highlights – January 2022 (27-01-2022).
- Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched (25-01-2022).
- Terugkijken: Press briefing on the entry into force of the EU Clinical Trials Regulation (25-01-2022).
- CTIS Training Programme, diverse modules bijgewerkt.
- EU foresees reenergized clinical trial sector as new regulations take effect (27-01-2022). Regulatory Focus.
- European Union seeks to promote large multi-country academic trials (27-01-2022). TranspariMED.
Commissie Regelgeving Onderzoek (COREON)
- Gedragscode Gezondheidsonderzoek.
- Gedragscode Gezondheidsonderzoek is gepubliceerd (25-01-2022). MLCF.
- Download: Gedragscode Gezondheidsonderzoek – Verantwoord omgaan met (persoons)gegevens en lichaamsmateriaal bij gezondheidsonderzoek (Januari 2022).
Clinical trial results reporting, Clinical trial registry, Transparancy
- Making transparency happen – a blog by Dr Naho Yamazaki Head of Policy and Engegement (27-01-2022). NHS Health Research Authority.
- How the FDA could save 2,700 clinical trials from becoming research waste (24-01-2022).
Data Archiving and Networked Services (DANS), instituut van KNAW en NWO
Data Monitoring Committee
- Ask the Experts: Setting the Data Monitoring Committee Up for Success (24-01-2022). WCG CenterWatch.
Dutch Techcentre for Life Sciences (DTL)
European Clinical Research Infrastructure Network (ECRIN)
- Supporting med-tech companies to win the innovation race: New TBMED video crosses the finish line (27-01-2022).
- The ERIC Forum is pleased to announce the release of its second policy brief (27-01-2022).
- IRDiRC publication on 10 years of progress (26-01-2022).
- New JAAM composition (24-01-2022).
European Medicines Agency (EMA)
- Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials – Revision 2 (28-01-2022).
- Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (28-01-2022).
- Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (28-01-2022).
- Meeting report – Learnings initiative webinar for optimal use of big data for regulatory purpose (28-01-2022).
European Patients Academy on Therapeutic Innovation (EUPATI)
- EUPATI launches a new collaborative project to facilitate matchmaking between EUPATI Patients Experts and researchers (25-01-2022).
- EUPATIConnect: Bringing EUPATI Patient Experts and researchers together
Inclusiviteit, Diversiteit, Representativiteit, Patient involvement
- Patients with schizophrenia hardly represented in antipsychotic drug studies (26-01-2022). Universiteit Maastricht.
- Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials. JAMA Psychiatry. Published online January 26, 2022.
- One man’s quest to boost the patient’s role in clinical trials (24-01-2022). PharmaVoice.
- The experiences, needs and barriers of people with impairments related to usability and accessibility of digital health solutions, levels of involvement in the design process and strategies for participatory and universal design: a scoping review (06-01-2022). BMC Public Health.
Informed consent
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
US Food and Drug Administration (FDA)
- Industry calls for flexibility on RWD data sources, validation (26-01-2022). Regulatory Focus.
- FDA finalizes guidances on PROs, patient engagement in device studies (25-01-2022). Regulatory Focus.
- FDA Shares Examples of Complex Clinical Trial Designs (24-01-2022). WCG CenterWatch.
- CDRH outlines plan to understand sex and gender differences in medical devices (24-01-2022). Regulatory Focus.
Wijziging van de Wet medisch-wetenschappelijk onderzoek met mensen in verband met de derde evaluatie van die wet alsmede enkele wijzigingen van technische aard (oa. electronische toestemming)
De Tweede Kamer heeft het voorstel op 27 januari 2022 als hamerstuk afgedaan.
Het voorstel is in behandeling bij de Eerste Kamercommissie voor Volksgezondheid, Welzijn en Sport (VWS). Tenzij een van de leden uiterlijk 8 februari 2022 kenbaar maakt schriftelijke voorbereiding te wensen, zal de commissie blanco eindverslag uitbrengen. Het voorstel wordt dan op 15 februari 2022 als hamerstuk afgedaan.
Overige berichten
- Integrating heterogeneous data to facilitate COVID-19 drug repurposing (februari 2022). Drug Discovery Today.
- Research on rare diseases: ten years of progress and challenges at IRDiRC (25-01-2022). Nature.
- Massive open index of scholarly papers launches (24-01-2022). Nature.
- What do we know about evidence-informed priority setting processes to set population-level health-research agendas: an overview of reviews. Bull Natl Res Cent 46, 6 (2022).
- The Use of Questionable Research Practices to Survive in Academia Examined With Expert Elicitation, Prior-Data Conflicts, Bayes Factors for Replication Effects, and the Bayes Truth Serum (29-11-2021). Front. Psychol.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties