Uitgelicht en gespot op internet (week 50, 2020)

Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:

Associatie van Contract Research Organisaties in Nederland (ACRON)

• Verklaring Geschiktheid Onderzoeksinstelling (VGO): de nieuwe basis voor efficiënt onderzoek! (10 december 2020).
• Vakinhoudelijke samenwerking op Europees niveau (7 december 2020).

Brexit

• NHS Brexit bulletin – 11 December 2020.
• Guidance Supplying investigational medicinal products to Northern Ireland from 1 January 2021 (11 december 2020). Medicines and Healthcare products Regulatory Agency.
• Ready, Steady, Brexit: Your Data Protection checklist for 1 January 2021 (december 2020). Bird & Bird.
• De gevolgen van Brexit voor dataverkeer tussen EU en UK ( 7 december 2020). Emerce.
• Terugkijken: Webinar: BREXIT – Impact on Clinical Trials Being Run in the UK (1 december 2020). Ergomed.

From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:

1. Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
2. Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
3. Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.

Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application … . The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.

…..

In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:

• Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
• Update section D.9.2.4.4 specifying “Northern Ireland” in the country field

When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.

-Bron: EudraCT Public website d.d. 7 december 2020

Biobanken

• Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding (4 december 2020). AJOB Emir Bioeth.

BBMRI.nl

• Expert Meetings
  • Terugkijken, presentaties en report: How to make health data available for research? Expert Meeting #3 (8 december 2020).
  • Terugkijken, presentaties en report: How to make health data available for research? Expert Meeting#2 (23 november 2020).
  • Terugkijken, presentaties en report: How to make health data available for research? Expert Meeting#1 (6 november 2020).
• Keen on sharing data for health research (21 oktober 2020).

COVID-19

• COVID-19 vaccine trial ethics once we have efficacious vaccines (11 december 2020). Science.
• Press release Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine (9 december 2020). Medicines and Healthcare products Regulatory Agency.
• COVID vaccines: the world’s medical regulators need access to open data (8 december 2020). Nature.
• Oxford COVID-vaccine paper highlights lingering unknowns about results (8 december 2020). Nature.
• New Vaccine Data Is Coming: Watch Out for These 3 Claims (8 december 2020). Wired.
• ‘For the greater good’: Black leaders in Baltimore work to overcome resistance to participating in COVID trials, other research (4 december 2020). The Baltimore Sun.

Data sharing

• Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. National Academy of Sciences.

Decentralized Trials & Research Alliance (DTRA) 

• Decentralized Trials & Research Alliance (DTRA) Launches to Democratize and Accelerate Clinical Trials. New Global Industry Coalition Aims to Dramatically Increase Access for All Patient Populations in Clinical Trials and Research (10 december 2020).

European Data Protection Supervisor (EDPS)

• Preliminary Opinion 8/2020 on the European Health Data Space (17 november 2020).

European Medicines Agency (EMA), Clinical Trials Information System (CTIS), ECTR

• CTIS Highlights, Issue 2, December 2020.

Health-RI

• Towards a Health data infrastructure and set of agreements (9 december 2020).
• Workshops on delivering FAIR metadata for COVID-19 data portal.
• New ELSI-flowcharts for researchers that use patient data or tissue (30 september 2020).
• Wanneer en met welke procedure moeten patiënten toestemming geven voor het nader gebruik van hun data of lichaamsmateriaal voor wetenschappelijk onderzoek?.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• Reflection Paper on Patient-Focused Drug Development for public consultation (7 december 2020).
• ICH reflection paper on proposed ICH guideline work to advance patient focused drug development. Via EMA.

Ministerie van Volksgezondheid, Welzijn en Sport (VWS)

• Resultaten onderzoek databeschikbaarheid voor AI in de zorg (4 november 2020). Capgemini Invent.

Patient Focus Development

• Engaging patients settles in and gets ready to scale.

Persoonsgegevens

• Recommendations of the EDPB Further to the CJEU’s Schrems II Judgment: One Step Forward, Two Steps Back? (10 december 2020). LexBlog.
• Terugkijken: Web Conference: ‘Schrems II’: What the EDPB Recommendations and Modernized SCCs Mean for You (9 december 2020). IAPP.
• EUCROF Code of Conduct weer een stapje verder (7 december 2020). ACRON.

ZonMw

• Terugkijken: Themawebinar ‘Inclusie voorop!’ (25 november 2020).
• Terugkijken: Webinar over ATMP’s: de opbrengst van translationeel onderzoek (2 november 2020).
• (Online) Masterclass Inclusie in onderzoek (15 oktober 2020).

Overige berichten

• India’s drug regulator has failed the pandemic stress test. The U.S. should take notice (11 december 2020). STAT.
• Pre‐registration: Why and How (3 december 2020). Journal of Consumer Psychology.
• Pre‐registration Is A Game Changer. But, Like Random Assignment, It Is Neither Necessary Nor Sufficient For Credible Science (3 december 2020). Journal of Consumer Psychology.
• Adolescent participation in HIV research: consortium experience in low and middle-income countries and scoping review (1 december 2020). Lancet HIV.
• Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019 (23 november 2020). JAMA Intern Med.
• Digitally Enabled, Patient‐Centric Clinical Trials: Shifting the Drug Development Paradigm (13 oktober 2020). Clinical and Translational Science.
• Digitizing clinical trials (31 juli 2020). npj Digital Medicine.
• Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study (19 februari 2020). Journal of Clinical and Translational Science.

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