Uitgelicht en gespot op internet (week 24, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Advanced Therapy Medicinal Products (ATMPs)
Algemene verordening gegevensbescherming (AVG)
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trials
- Walgreens enters clinical trial business to boost access (17-06-2022). Clinical Trials Arena.
- Walgreens Launches Clinical Trial Business (16-06-2022). Applied Clinical Trials.
- Early phase cancer trials: how to draft a successful blueprint (17-06-2022). Clinical Trials Arena.
- A Checklist for Optimizing Clinical Trial Study Startup Activities (17-06-2022). Advarra.
- Parexel Expands Patient Access to Clinical Trials Through New Community Alliance Network (16-06-2022). Applied Clinical Trials.
- Beyond clinical trial design: factors that impact decentralisation (16-06-2022). Clinical Trials Arena.
- Hope, Hype, Happening: Our Current Era of Clinical Trials (14-06-2022). Applied Clinical Trials.
- Clincierge Releases Study on Patient Experience in Clinical Trials (14-06-2022). Applied Clinical Trials.
- How Decentralized Clinical Trial (DCT) Design Brings Clinical Research as a Care Option to Cancer Patients (14-06-2022). Applied Clinical Trials.
- Estimation of treatment effects in short-term depression studies. An evaluation based on the ICH E9(R1) estimands framework (09-06-2022). Pharmaceutical Statistics.
- Pharma Intelligence report indicates 8.8% annual increase in sponsored clinical trials. A 21% decrease in reported clinical trial termination hints at recovery from COVID impact (08-06-2022). Healthcare Radius.
Clinical trials results reporting
- Naming and Shaming is Driving Improvements in Reporting of Clinical Trial Results (17-06-2022). Applied Clinical Trials.
- New TranspariMED campaign: Stop medical research waste in Germany (14-06-2022). TranspariMED.
- How the UK is ending research waste – explained in 153 words (14-06-2022). TranspariMED.
- No need to redact clinical trial data, medical journals tell regulators (06-06-2022). TranspariMED.
- Improving clinical trial transparency at UK universities: Evaluating 3 years of policies and reporting performance on the European Clinical Trial Register (16-02-2022). Clinical Trials.
Commissie Regelgeving Onderzoek (COREON)
Data sharing, FAIR, Open Science
- The YOUth cohort demonstrates Open Science in practice (15-06-2022). Universiteit Utrecht.
- Applying the FAIR principles to data in a hospital: challenges and opportunities in a pandemic (25-04-2022). Journal of Biomedical Semantics.
Diversiteit, Inclusiviteit, Representativiteit
- Clinical trial diversity: Sponsors seek clarity on data sources, timing (15-06-2022). Regulatory Focus.
- Popular drug may have new benefit in men with diabetes, but not women, study shows (15-06-2022). STAT.
- Listen: Diverse clinical trials: Why aren’t we there yet? (13-06-2022). STAT.
- Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce (13-06-2022). Applied Clinical Trials.
- Use of Race in Pediatric Clinical Practice Guidelines. A Systematic Review (06-06-2022). JAMA Pediatr.
- Association of Estimated GFR Calculated Using Race-Free Equations With Kidney Failure and Mortality by Black vs Non-Black Race. JAMA. Published online June 06, 2022.
Dutch Oncology Research Platform (DORP)
European Commission, Nanomaterial
European Medicines Agency (EMA)
“The Board stressed the importance of the communication efforts needed to make sponsors prepare for the approaching deadline of 31 January 2023. As of that date all applications for new trials must go directly through the Clinical Trials Information System (CTIS).”
bron: EMA Management Board: highlights of June 2022 meeting (17-06-2022).
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Global Alliance for Genomics and Health (GA4GH)
- GA4GH GDPR Brief: data protection implications of publishing metadata to enable discovery (17-06-2022).
- GA4GH Data Access Committee Review Standards’ policy aims to standardise the data access process (10-06-2022).
Integrity, Fraud
- Is There an Epidemic of Research Fraud in Natural Medicine?. Integr Med (Encinitas). 2022;21(2):14-18.
- Comments – Is There an Epidemic of Research Fraud in Natural Medicine?. Integr Med (Encinitas). 2022;21(2):19-20.
- Disgraced Windpipe Surgeon Convicted In Sweden For Harming Patient (16-06-2022). AFP News, via Barron’s.
Kunstmatige Intelligentie (KI)
- AI Holds Potential to Support Ethical Principles in Hematology—but There’s a Dark Side.
- Sense about Science
Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), Medical Device Coordination Group (MDCG)
- Gebruiksaanwijzingen: Waarschuwingen en Voorzorgsmaatregelen (15-06-2022). Quality Business Support Blog.
- Biocompatibiliteit van hulpmiddelen die in contact komen met de intacte huid (13-06-2022). Quality Business Support Blog.
- The difference between PMS and PMCF in one minute. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) (11-06-2022). Boumans Regulatory Consulting.
Nederlandse Hart Registratie (NHR)
NHS Health Research Authority (HRA), Verenigd Koninkrijk
- New ‘public conversation’ looks at ethics review for health and social care research (10-06-2022).
- Making it easy to do research that people can trust (08-06-2022).
Proefschriften
U.S. Food and Drug Administration (FDA), Verenigde Staten
- Newly added guidance documents:
Vereniging Innovatieve Geneesmiddelen
Overige berichten
- Weekend reads: Automated peer review; ‘journal editors resign in protest;’ attention to retracted papers (18-06-2022). Retraction Watch.
- Drug Discovery Today. Volume 27, Issue 7, Pages 1785-2042 (July 2022).
- Get law enforcement out of biospecimen authentication (16-06-2022). Science.
- An analysis of retracted papers in Computer Science (14-06-2022). arXiv.
- IP nationalism: the unexamined issue underlying the controversial WTO vaccine proposal and beyond (14-06-2022). STAT.
- The Peer-Review Crisis (13-06-2022). Inside Higher Ed.
- Disclosing Alzheimer Disease Biomarker Results to Research Participants (06-06-2022). JAMA Neurol.
- Can we do that here? An analysis of US federal and state policies guiding human embryo and embryoid research, Journal of Law and the Biosciences, Volume 9, Issue 1, January-June 2022, lsac014.
- Renowned journal rejects papers that exclude African researchers (03-06-2022). University World News.
- Moving from ‘fully’ to ‘appropriately’ informed consent in genomics: The PROMICE framework (16-06-2022). Bioethics
- Informed consent in a tuberculosis genetic study in Cameroon: information overload, situational vulnerability and diagnostic misconception (14-06-2022). Research Ethics.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties