Bekijk deze e-mail in uw browser

Nr. 73
5 december 2018

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 5 december 2018, met de laatste ontwikkelingen rond medisch-wetenschappelijk onderzoek met mensen, nieuwe wetgeving en gereviseerde richtlijnen.

De komende weken verwacht ik niet veel nieuwe ontwikkelingen. De Tweede Kamer is van 21 december tot en met maandag 14 januari 2019 met kerstreces, en ook veel bedrijven zien het einde van 2018 al snel naderen. Eigenlijk is er nog maar 1 ontwikkeling te verwachten dit jaar en dat is de door de DCRF werkgroep CTA toegezegde herziene versie van de DCRF model overeenkomst. Ik heb nog even gewacht met het verzenden van deze nieuwsbrief, maar vooralsnog geen herziene versie beschikbaar. We zullen dus nog even geduld moeten hebben.

Met vriendelijke groet,

Vincent Bontrop

www.bontrop.com

Link met mij via LinkedIn.

Inhoudsopgave

• Samenwerking UMC Utrecht en Prinses Máxima Centrum in gezamenlijke METC
• TransCelerate publiceert herziene versie Common Protocol Template, Common Statistical Analysis Plan en Common Clinical Study Report templates
• Uitgelicht: Gene editing, CRISPR baby's in China
• Meer nieuws
• Bijeenkomsten
• Publieke consultaties

• Nieuwsbrief doorsturen
• Voorkeuren aanpassen
• Abonneren op deze nieuwsbrief
• Eerder verschenen uitgaven

• Contactgegevens

Samenwerking UMC Utrecht en Prinses Máxima Centrum in gezamenlijke METC

Het UMC Utrecht en het Prinses Máxima Centrum voor kinderoncologie hebben op 28 november 2018 aangekondigd met ingang van 1 januari 2019 te gaan samenwerken op het gebied van de toetsing van medisch-wetenschappelijk onderzoek met mensen. De Medisch Ethische Toetsingscommissie van het UMC Utrecht gaat vanaf 1 januari verder onder de naam METC Utrecht.

"Per 1 januari 2019 zal het Prinses Máxima Centrum al haar medisch wetenschappelijk onderzoek laten toetsen door de gezamenlijke METC. Ook de studies die lopen via SKION (Stichting Kinderoncologie Nederland) kunnen dan door de METC Utrecht getoetst gaan worden." (Bron: METC UMC Utrecht 'Samenwerking METC/Collaboration MREC' d.d. 28 november 2018)

Bron/Lees verder

TransCelerate publiceert herziene versie Common Protocol Template, Common Statistical Analysis Plan en Common Clinical Study Report templates

TransCelerate heeft eind november een herziene versie van het Common Protocol Template (CPT) vrijgegeven.

"In this release, we are aligning to the EU Clinical Trial Regulations, recent updates to ICH regulations (E6 and E9), and continue to align with the Protocol Template developed by the National Institutes of Health (NIH) and US Food and Drug Administration (FDA)." (Bron: TransCelerate CPT webpagina)

"For the first time, we are also releasing the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates." (Bron: TransCelerate CPT webpagina)

Lees verder

Download Summary of Changes November 2018 Release

Uitgelicht: Gene editing, CRISPR baby's in China

• Chinese Scientist Says He's First To Create Genetically Modified Babies Using CRISPR (26 november 2018). NPR.
  • The He Lab. About Lulu and Nana: Twin girls born healthy after gene surgery as single-cell embryos. YouTube. November 25, 2018.
  • The He Lab. Why we chose HIV and CCR5 first. YouTube. November 25, 2018.
  • J. He et al. Draft ethical principles for therapeutic assisted reproductive technologies. CRISPR Journal. Published online November 26, 2018. doi:10.1089/crispr.2018.0051.
• ‘CRISPR babies’ lab asked U.S. scientist for help to disable cholesterol gene in human embryos (4 december 2018). STAT.
• He Jiankui’s Moral Mess (3 december 2018). PLOS Biologue blog.
• We need a temporary moratorium on using gene editing to create babies (3 december 2018). STAT.
• The Ethics of Heritable Genome Editing New Considerations in a Controversial Area. JAMA. Published online December 03, 2018. doi:10.1001/jama.2018.18270
• An ‘epic scientific misadventure’: NIH head Francis Collins ponders fallout from CRISPR baby study (30 november 2018). Science.
• China suspends all projects of gene-edited baby scientist He Jiankui, and says those involved will be punished (29 november 2018). South China Morning Post.
• On Human Genome Editing II. Statement by the Organizing Committee of the Second International Summit on Human Genome Editing (29 november 2018). Academy of Sciences of Hong Kong, Royal Society of the United Kingdom, U.S. National Academy of Sciences & U.S. National Academy of Medicine.
• China halts genome editing research that led to claimed birth of CRISPR babies (29 november 2018). STAT.
• Ethics aside, does the CRISPR baby experiment make scientific sense? (28 november 2018). Science.
• Second Woman Implanted With Genetically Modified Embryo, Scientist Says (28 november 2018). The Wall Street Journal.
• The researcher who created CRISPR twins defends his work but fails to quell controversy (28 november 2018). Science News.
• Researcher who created CRISPR twins defends his work but leaves many questions unanswered (28 november 2018). Science.
• Chinese scientists raise ethical questions with first gene-edited babies (27 november 2018). Science News.
• How the genome-edited babies revelation will affect research (27 november 2018). Nature
• Scientists, officials in China abhor gene editing that geneticist claims (27 november 2018). Reuters.
• Rogue Chinese CRISPR scientist cited US report as his green light (27 november 2018). MIT Technology Review.
• CRISPR inventor Feng Zhang calls for moratorium on gene-edited babies (26 november 2018). MIT Technology Review.
• Genome-edited baby claim provokes international outcry (26 november 2018). Nature.
• The Chinese scientist who claims he made CRISPR babies is under investigation (26 november 2018). MIT Technology Review.
• China orders investigation after scientist claims first gene-edited babies (26 november 2018). Reuters.
• An outsider claimed to make genome-editing history — and the world snapped to attention (26 november 2018). STAT.

Meer nieuws

Algemene verordening gegevensbescherming (AVG, GDPR)

• Workshop report: Data anonymisation - a key enabler for clinical data sharing (4 december 2018). European Medicines Agency.
• Die belemmerende Brusselse privacyregels… (27 november 2018). KNMG.

Bevolkingsonderzoek met wetenschappelijk onderzoek

• Erasmus MC mag geen proefbevolkingsonderzoek prostaatkanker uitvoeren (28 november 2018). Medisch Contact.
  • WBO: onderzoek naar screening op prostaatkanker (27 november 2018). Gezondheidsraad.

Biobanking

• Mini-levers voor onderzoek naar leveraandoeningen (29 november 2018). Hubrecht Instituut.
• Introducing CTRL: a new online research consent and engagement platform (27 november 2018). Australian Genomics Health Alliance.
• Consent requirements for research with human tissue: Swiss ethics committee members disagree (26 november 2018). BMC Medical Ethics 2018 19:93.
• Is it time for a universal genetic forensic database?. Science  23 Nov 2018: Vol. 362, Issue 6417, pp. 898-900.
• Practice evaluation of biobank ethics and governance: current needs and future perspectives Journal of Medical Genetics Published Online First: 21 November 2018.
• German Biobank Node: Handbook for quality management in biobanking (19 oktober 2018). Zenodo.

Brexit

• Schouw: 'Verhuizing FDA naar Amsterdam is opsteker' (3 december 2018). Vereniging Innovatieve Geneesmiddelen.
• FDA volgt EMA van Londen naar Amsterdam (2 december 2018). Het Parool.
  • FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products (29 november 2018). U.S. Food and Drug Administration.

Clinical Data Interchange Standards Consortium

• Study Data Tabulation Model (SDTM) version 1.7
• SDTM Implementation Guide version 3.3
• Colorectal Cancer Therapeutic Area User Guide v1.0

Clinical trials

• Inspectie onderzoekt studie drainage galwegkanker AMC (28 november 2018). Medisch Contact.
  
  • Inspectie stelt onderzoek in naar UMC-studie met veertien doden (27 november 2018). AD.
• FDA Warns Investigator for Violating Clinical Hold (27 november 2018). Regulatory Focus.

Digital tools, new technologies

• FDA’s MyStudies release is a ‘major milestone’ with ‘profound’ implications, says Iqvia (4 december 2018). Outsourcing Pharma.
• Fostering the adoption of new clinical trial design supported by digital tools (29 november 2018). European Federation of Pharmaceutical Industries and Associations.
• FDA Commissioner Challenges Clinical Trial Industry to Embrace New Technologies (28 november 2018). ACRP blog.
• Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges. Therapeutic Innovation & Regulatory Science.

European Medicines Agency

• Data from patient registries to replace clinical trials in previously untreated haemophilia patients (30 november 2018).

Experimentele behandeling

• Experimental treatments – supporting patient choice while protecting them from harm (26 november 2018). Nuffield Council on Bioethics.

Good Clinical Practice

• Sponsors Pilot New ICH E6 R2 Initiatives (3 december 2018). Applied Clinical Trials.
• Report: Annual report of the Good Clinical Practice Inspectors Working Group 2017 (27 november 2018 gepubliceerd).

Good Manufacturing Practice

• Erkenning van het FAGG door de Amerikaanse Food and Drug Administration (FDA) (3 december 2018).
• Five additional countries to benefit from EU-US mutual recognition agreement for inspections (29 november 2018).
  • Mutual recognition agreements (MRA).
  • Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 December 2018 (29 november 2018).

Medical Research Council

• New funding scheme supporting clinical research capacity (30 november 2018).

Medicines and Healthcare products Regulatory Agency

• Dose Escalation - is it GCP compliant? (26 november 2018). Blog MHRA Inspectorate.

Medische hulpmiddelen

• Ceci n’est pas une période de transition and first reaction to the Implant Files (2 december 2018). Medicaldeviceslegal.
• The Implant Files (28 november 2018). Quality Business Support.
• FDA overhauls approval process as medical devices come under fire (27 november 2018). CNN.
• Reactie IGJ op berichtgeving Trouw en Radar (26 november 2018). Inspectie Gezondheidszorg en Jeugd.
• Reactie van het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) op de ‘Implant Files’ (26 november 2018).

Open access, funding, onderzoeksdata

• Data4lifesciences lanceert HANDS 2.0 (28 november 2018). NFU
  • Data4lifesciences. NFU.
  • Handbook for Adequate Natural Data Stewardship (HANDS 2.0).
• Biomedical research is becoming more open about its funding and data (27 november 2018). Nature.
• Funders flesh out details of Europe’s bold open-access plan (27 november 2018). Nature.
• Do You Have Concerns about Plan S? Then You Must be an Irresponsible, Privileged, Conspiratorial Hypocrite (26 november 2018). The Scholary Kitchen.

Proefschrift

• Lustberg, T. (2018). Learning from routinely produced clinical data and Big Data technology in Radiation Oncology Maastricht: Datawyse / Universitaire Pers Maastricht DOI: 10.26481/dis.20181206tl
• Peerdeman, K.J. (2018). Harnessing placebo effects by targeting expectancies. Leiden.

US Food and Drug Administration

• FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies (20 november 2018). The National Law Review.
• FDA Proposes Changes to Clinical Trial Informed Consent Rules (15 november 2018). The National Law Review.

Uitgelicht

• The drug repurposing landscape from 2012 to 2017: evolution, challenges, and possible solutions, Drug Discovery Today, 2018.
• A colleague included plagiarized material in your grant proposal. Are you liable? (3 december 2018). Retraction Watch.
• Audit trail en audit trail review (30 november 2018). Quality Business Support.
• Improving Electronic Health Record Usability and Safety Requires Transparency. JAMA. Published online November 29, 2018. doi:10.1001/jama.2018.14079
• Sample size calculation in multi-centre clinical trials (29 november 2018). BMC Medical Research Methodology 2018 18:156.
• Exploring reporting quality of systematic reviews and Meta-analyses on nursing interventions in patients with Alzheimer’s disease before and after PRISMA introduction. BMC Medical Research Methodology 2018 18:154.
• Improving the quality of reporting of systematic reviews of dose-response meta-analyses: a cross-sectional survey. BMC Medical Research Methodology 2018 18:157.
• The interaction of personal, contextual, and study characteristics and their effect on recruitment and participation of pregnant women in research: a qualitative study in Lebanon. BMC Medical Research Methodology 2018 18:155.
• Statistical pitfalls of personalized medicine (27 november 2018). Nature.
• Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance (26 november 2018). Trials 2018 19:653.
• EU ‘fully committed’ to ending animal testing, insists Commissioner (26 november 2018). Euractiv.
• The patient advocates will see you now: Cancer groups trial the AIDS model for interacting with industry (26 november 2018). ESO, Cancerworld.
• The double standard of retractions (25 november 2018). The Varsity.
• Increasing the Participation of Pregnant Women in Clinical Trials. JAMA. 2018;320(20):2077–2078. doi:10.1001/jama.2018.17716
• One And Done: How Bad Is The PI Turnover Problem? (21 november 2018). Clinical Leader.
• Revised FIH guidelines: AstraZeneca reflects a year later  (20 november 2018). Outsourcing Pharma.
• Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatr. Published online November 19, 2018.
• Towards minimal reporting standards for life scientists (1 november 2018). Nature.com blogs.
• Preprints are coming to clinical research. Reporters, are you ready? la Fundación Gabriel García Márquez para el Nuevo Periodismo Iberoamericano.

4 december 2018 - BBMRI-ERIC Quality Management Webinar #4 'State-of-the-art of next-generation sequencing'

Tijdstip: 10:30 - 11:30 CET

Lees verder

6 december 2018 - CORBEL Webinar: BBMRI-ERIC Quality Management Services for basic and applied research

Tijdstip: 15:30 - 16:30 CET

Lees verder

17 januari 2019 - BBMRI-ERIC Quality Management Webinar #5 'Data Quality for Biobanks'

Tijdstip: 10:30 - 11:30 CET

Lees verder

28 - 29 januari 2019 - 3rd annual Patients as Partners EU

Locatie: Londen

Lees verder

12 - 13 februari 2019 - ECCRT* Data Transparency Conference: Demystifying Clinical Data Transparency: Lessons learnt so far

*ECCRT = European Centre for Clinical Research Training

Locatie: Brussel

Lees verder

13 - 14 februari 2019 - 3rd EURORDIS Multi-Stakeholder Symposium on Improving Patients’ Access to Rare Disease Therapies

Locatie: Brussel

Lees verder

14 februari 2019 - Innovation for Health 2019

Locatie: Rotterdam

Lees verder

14 - 15 februari 2019 - 7th ACCELERATE Paediatric Oncology Conference

Locatie: Brussel

Lees verder

13 maart 2019 - MHRA Laboratories Symposium

Locatie: Londen

Lees verder

4 april 2019 - ZonMw: 7e congres Goed Gebruik Geneesmiddelen

Locatie: Amsterdam

Lees verder

29 september - 2 oktober 2019 - SCDM 2019 Annual Conference

Nog geen programma beschikbaar

Locatie: Baltimore

Lees verder

CDISC Therapeutic Area User Guide for Lung Cancer v1.0

Consultatie loopt tot 21 december 2018

Lees verder

PIC/S: Draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

Consultatie loopt tot 28 februari 2019

Lees verder

EMA: Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Consultatie loopt tot 30 juni 2019

Lees verder

Meer bijeenkomsten en consultaties:

• Supplement 'Bijeenkomsten & Consultaties' - december 2018

Heeft u een vraag, of een verzoek?  U kunt mij bereiken door te antwoorden op deze e-mail, via het contactformulier op mijn website, of door een e-mail te sturen naar: info@bontrop.com

Copyright © Vincent Bontrop, All rights reserved.

Contactgegevens:
Hopakker - 3514 BZ Utrecht - Netherlands

This email was sent to {email}
Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list