Uitgelicht en gespot op internet (week 39, 2021)

Hierbij een nieuw overzicht van actualiteiten en nieuwsberichten de de afgelopen week zijn gespot op het internet.

Vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen.

Heeft u zelf nieuws, een evenement of enquête/consultatie gespot? Geef ze aan mij door via het contact formulier hier op mijn weblog.

---

Algemene verordening gegevensbescherming, Data doorgifte, SCC

• Bird & Bird SCC Generator Tool

Biobanken, Wet zeggenschap lichaamsmateriaal

• Wet zeggenschap lichaamsmateriaal
  • Terugkijken:  Technische briefing (28 september 2021).
    • Bijlage – Presentatie Wet zeggenschap lichaamsmateriaal (Wzl) 28 september 2021.
  • Voortgang wetsvoorstel: Regels voor handelingen met lichaamsmateriaal, welke worden verricht voor andere doeleinden dan geneeskundige behandeling of diagnostiek van de donor (Wet zeggenschap lichaamsmateriaal) (35.844)

Brexit

• What might Brexit mean for UK and international bioethics? (29 september 2021). Nuffield Council on Bioethics.

Clinical trials

• Informed consent in cluster randomised trials: a guide for the perplexed (27 september 2021). BMJ Open.
• Healthy Volunteers in First in Human Oncology Drug Development for Small Molecules (23 september 2021). British Journal of Clinical Pharmacology.
• Amplifying Patient Voices in Protocol Design (8 september 2021). Applied Clinical Trials.

Clinical trial results reporting

Data integrity

• Two Indian CROs under lens as United States raises data integrity issues (27 september 2021). The Economic Times.

Dierexperimenteel onderzoek

• EMA implements new measures to minimise animal testing during medicines development (29 september 2021). EMA.
• EMA announces new efforts to minimize animal testing (1 oktober 2021). Regulatory Focus.
• Treatment of laboratory animals changed, but humans remained in charge. “Animal testing still revolves around human health” (20 september 2021). Universiteit Utrecht.

ECTR, CTIS

• CTIS Training Programme
  • CTIS User Personas (Classified as internal/staff & contractors by the European Medicines Agency)
  • CTIS User Personas (Classified as public by the European Medicines Agency)

Embryo-onderzoek

• The next frontier for human embryo research (29 september 2021). Nature.

EU In Vitro Diagnostics Regulation (IVDR)

• Uitnodiging IVDR-webinar In-huis ontwikkelde tests (29 september 2021). NFU.

European Medicines Agency (EMA)

• Call for expressions of interest for civil society representatives to participate in work of Committee for Advanced Therapies (24 september 2021).
• PRAC & Management Board: Call for expressions of interest for civil society representatives to participate in work of EMA (22 september 2021).
• European Medicines Agency’s Privacy Statement For the clinical data publication website (27 september 2021).

Good Clinical Practice (GCP)

• Development of a Good Clinical Practice inspection checklist to assess clinical trial sites in Vietnam (26 juli 2021). BMJ Open.

Health-RI

• Health-RI gaat voor sneller en beter gezondheidsonderzoek en innovatie (30 september 2021).

Inclusie, Involvement, Recruitment, Representatieve steekproef

• Paying participants isn’t the way to improve clinical trial recruitment (28 september 2021). STAT.
• Effectiveness and Ethics of Incentives for Research Participation 2 Randomized Clinical Trials (20 september 2021). JAMA Internal Medicine.
• Fair payment and just benefits to enhance diversity in clinical research (14 juli 2021). Journal of Clinical and Translational Science.
• Research Equity and Enrolling Non-English Speakers (27 september 2021). Advarra.
• A teenager on TikTok disrupted thousands of scientific studies with a single video (24 september 2021). The Verge.
• Facilitating the inclusion of adults with intellectual disability as direct respondents in research: Strategies for fostering trust, respect, accessibility and engagement (24 september 2021). Journal of Applied Research in Intellectual Disabilities.
• Introducing patient and public involvement practices to healthcare research in Austria: strategies to promote change at multiple levels (9 augustus 2021). BMJ Open.
• Considerations for Cardiovascular Genetic and Genomic Research With Marginalized Racial and Ethnic Groups and Indigenous Peoples: A Scientific Statement From the American Heart Association (26 juli 2021). Circulation: Genomic and Precision Medicine.

Master protocols, Umbrella protocols, Basket/Bucket protocols, Platform protocols

• Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials. Ther Innov Regul Sci. 2021 Jun 23.
• The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review (juli 2020). Clinical Therapeutics.
• Master protocols: New directions in drug discovery (juni 2020). Contemporary Clinical Trials Communications.
• Reporting of master protocols towards a standardized approach: A systematic review (september 2019). Contemporary Clinical Trials Communications.
• Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols (18 september 2019). Trials.
• Umbrella and basket trials in oncology: ethical challenges (23 augustus 2019). BMC Medical Ethics.
• Master protocols in clinical trials: a universal Swiss Army knife? (juni 2021). The Lancet Oncology.
• “FDA Modernizes Clinical Trials with Master Protocols” February 26, 2019 Issue (26 februari 2019). U.S. Food and Drug Administration.
• Draft guidance: Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics (Oktober 2018). U.S. Food and Drug Administration.
• Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both (6 juli 2017). NEJM.
• Efficiencies of platform clinical trials: A vision of the future (17 februari 2016). Clinical Trials.
• The Master Protocol Concept (oktober 2015). Seminars in Oncology.
• CTTI: Master protocol studies

Medicines and Healthcare products Regulatory Agency (MHRA)

• Guidance on GxP data integrity (updated 27 september 2021). Medicines and Healthcare products Regulatory Agency.
  Added new information titled ‘Good Laboratory Practice (GLP)’
• Updated data integrity requirements for GLP Monitoring Programme members (27 september 2021).

Placebo

• ‘Denk goed na over je woorden als arts’ Andrea Evers over de talige omlijsting van een behandeling (30 september 2021). Medisch Contact.

Publications, Preprints

• Preprints in times of COVID19: the time is ripe for agreeing on terminology and good practices (28 juli 2021). BMC Medical Ethics.

Training, Educatie

• Introduction to the Principles and Practice of Clinical Research (IPPCR). National Institutes of Health. (gratis cursus)

U.S. Food and Drug Administration

• Draft guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices (29 september 2021).
  • FDA drafts safety reporting guidance for drug and device investigators (1 oktober 2021). Regulatory Focus.
• Draft guidance: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (28 september 2021).
• Draft guidance: Benefit-Risk Assessment for New Drug and Biological Products (september 2021).
  • FDA draft guidance outlines criteria for conducting benefit/risk assessments (1 oktober 2021). Regulatory Focus.
• CHAPTER 48 – Bioresearch Monitoring. Sponsors and Contract Research Organizations (15 september 2021).
• Getting Through Inspections: Seasoned Research Institution Details Successful Strategies (27 september 2021). WCG CenterWatch.

Overige

• Weekend reads: Paper mill sanctions; UT Austin suspends prof, repays grant funds; researchers in Mexico threatened with arrest (2 oktober 2021). Retraction Watch.
• Meer inzicht in belasting bijwerkingen biologicals (30 september 2021). Skipr.
• Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies (28 september 2021). Drug Discovery Today.

---

Meer actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com

consultations.bontrop.com

events.bontrop.com