Uitgelicht en gespot op internet (week 47, 48 & 49)

Beste abonnee,

Enigszins later dan gepland ontvangt u hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘.

Door een zware verkoudheid en drukte rond mijn nieuwe uitdaging binnen het UMC Utrecht heb ik pas dit weekend tijd gevonden het nieuws van de afgelopen drie weken te verwerken. De verwachting is dat er aankomende maandag ook weer een nieuwe uitgave van de Nieuwsbrief voor Goede Onderzoekspraktijken zal worden verstuurd.

Heeft u nog nieuwstips voor de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘ of een uitgave van ‘Uitgelicht en gespot op internet‘? U kunt mij bereiken door gebruik te maken van het contactformulier op de website.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn.

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Uitgelicht & Gespot op Internet

Algemene verordening gegevensbescherming, Lichaamsmateriaal, Privacy

• ‘Nederlanders relatief voorzichtig met delen van persoonlijke gezondheidsdata’ (5 december 2019). ICT &Health.
• [Federa COREON] Gedragscode gegevensverwerking gaat op de schop (4 december 2019). Skipr.
• Fine against hospital due to data protection deficits in patient management (3 december 2019). European Data Protection Board.
• GA4GH GDPR Brief: Is ‘consent for genomic and health-related research’ specific enough to constitute a valid consent under the GDPR? (December 2019)
• Balancing Data Use and Data Privacy in Europe (2 december 2019). Applied Clinical Trials.
• Brief regering: Reactie op verzoek commissie over het artikel in de NRC van 25 oktober 2019 “Wie gluren er allemaal in mijn medische dossier?” (29 november 2019). Ministerie van Volksgezondheid, Welzijn en Sport.
• Definitieve DPIA-lijst beschikbaar (27 november 2019). Autoriteit Persoonsgegevens.
• Privacyregels staan Nederlandse Hart Registratie in de weg (26 november 2019). Skipr.
• Infographic: Safeguarding Privacy Rights in Human Subject Research – a practical GDPR approach. Marlon Domingus, via LinkedIn.
• Waarom persoonsgegevens tot eigendom verklaren een heel slecht idee is (21 november 2019). Internetrecht door Arnoud Engelfriet.
• GDPR en medisch-wetenschappelijk onderzoek (20 november 2019). Tijdschrift voor Gezondheidsrecht.
• European data law is impeding studies on diabetes and Alzheimer’s, researchers warn (20 november 2019). Science.
• EDPB Adopts Final Version of Guidelines on Territorial Scope of the GDPR (20 november 2019). LexBlog.
• Privacybescherming is niet gediend met starre wetsuitleg  (18 november 2019). NTvG.
• Lichaamsmateriaal meestal zonder toestemming gebruikt (18 november 2019). Skipr.
• Amsterdam UMC stelt gegevens over IC-patiënten beschikbaar om levens te redden (17 november 2019). Amsterdam UMC.
  • Amsterdam Medical Data Science. Home of AmsterdamUMCdb, the first freely available European ICU database.
  • Amsterdam UMC stelt data ic-patiënten beschikbaar (18 november 2019). Medisch Contact.

Associatie van Contract Research Organisaties in Nederland

• ACRON-symposium in teken ‘Nederland als onderzoeksland’ (3 december 2019). Vereniging Innovatieve Geneesmiddelen.

Centralized monitoring, Risk-Based Monitoring

• Using Statistics to Improve Data Quality and Maximize Trial Success (4 december 2019). Applied Clinical Trials.
• Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies. ACRO.

Clinical trials, Inclusie, Engagement, Retention

• Partnering with Patients: Clinical Trial Retention and Engagement through Patient Data Return (5 december 2019). Applied Clinical Trials.
• A clinical trial for Huntington’s opens the door to hope for some patients. Only so many can get in (4 december 2019). STAT.
• Clarifying the Meaning of Clinically Meaningful Benefit in Clinical Research (2 december 2019). JAMA.
• U.S. women’s views on delaying pregnancy for the purpose of participating in biomedical research (December 2019). AJOG.
• Valt patiënteninclusie tegen? (28 november 2019). Dutch Oncology Research Platform.
• Mixing mixed-mode designs in a national health interview survey: a pilot study to assess the impact on the self-administered questionnaire non-response (21 november 2019). BMC Medical Research Methodology.
• Bijeenkomst over patiënteninclusie (19 november 2019). ZonMw.
• Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research (11 november 2019). Circulation.
• How patient experience mapping can improve patient recruitment and retention (31 oktober 2019). Insight Hub.

Clinical trials, eSource, Risk/Benefit, Startup, Study design,

• Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study (2 december 2019). Trials.
• Protocols—more structure, less ‘Wuthering Heights’ (28 november 2019). Trials.
  • Structured Study Protocol Template. Trials.
• True and false positive rates for different criteria of evaluating statistical evidence from clinical trials (27 november 2019). BMC Medical Research Methodology.
• Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants (27 november 2019). BMC Medical Ethics.
• Protocol Deviation Reporting: Cutting Through The Ambiguity (26 november 2019). Clinical Leader.
  • Improving Study Quality with PDV Codes (2017). Journal of Clinical Research Best Practice.
• Reprioritizing Risk and Benefit: The Future of Study Design in Early‐Phase Cancer Research (19 november 2019). Ethics & Human Research.
• Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards (19 november 2019). Ethics & Human Research.
• HIV Cure Research: Risks Patients Expressed Willingness to Accept (19 november 2019). Ethics & Human Research.
• eSRA checklist (19 november 2019). Dutch Clinical Research Foundation.
• Reconceptualising risk–benefit analyses: the case of HIV cure research (15 november 2019). Journal of Medical Ethics.
• Mayo’s Startup Acceleration Project Cuts Timelines Dramatically (15 november 2019). CenterWatch.

Clinical trial results reporting, Results reporting

• Completeness of reporting in abstracts of randomized controlled trials in subscription and open access journals: cross-sectional study (2 december 2019).  Trials.
• Analysis of reporting completeness in exercise cancer trials: a systematic review (2 december 2019). BMC Medical Research Methodology.
• These five German universities are the least transparent medical research institutions in Europe (30 november 2019). TranspariMED.
  
• ISRCTN clinical trial registry reporting results (25 november 2019). TranspariMED.
• BPI clinical trial transparency (22 november 2019). TranspariMED.
• Irish medical schools excel at reporting clinical trial results (21 november 2019). TranspariMED.
• Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study (19 november 2019). BMC Medicine.
• Comments on “Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals” (19 november 2019). Trials.
• Checklists for Authors Improve the Reporting of Basic Science Research (13 november 2019). Stroke.

Deviations from pre-specified study plans

• Questions on ‘Intervention effects of a kindergarten-based health promotion programme on obesity related behavioural outcomes and BMI percentiles’ (21 november 2019). Preventive Medicines Reports.
• Correspondence: Questions on ‘Intervention effects of a kindergarten-based health promotion programme on obesity related behavioural outcomes and BMI percentiles’ (21 november 2019). Preventive Medicines Reports.

Data sharing

• Delen medische data voor meeste patiënten geen punt (18 november 2019). Patiëntenfederatie Nederland.
  • Rapport Delen van uw data. Hergebruik van gezondheidsgegevens en lichaamsmateriaal voor wetenschappelijk onderzoek (November 2019). Patiëntenfederatie Nederland.
  • Patiëntenmonitor ‘Delen van gezondheidsgegevens voor onderzoek (November 2019).
• Delen medische data voor meeste patiënten geen punt (18 november 2019). Medisch Contact.
• Sharing clinical trial data: lessons from the YODA Project (18 november 2019). STAT.
• Why NIH is beefing up its data sharing rules after 16 years (11 november 2019). Science.
  • NIH Requests Public Comment on a Draft Policy for Data Management and Sharing and Supplemental Draft Guidance (6 november 2019). NIH Office of Science Policy.

Dierexperimenteel onderzoek

• Consider the Mouse (6 december 2019). The Hastings Center.
• Minder proefdieren medicijnonderzoek door andere richtlijn (18 november 2019). Skipr.
• Applying the 3Rs in drug development: Improving delivery of innovative treatments to patients (16 oktober 2019). NC3Rs.

Dutch Clinical Research Foundation, VWS brochure

• Wijziging VWS brochure voor proefpersonen (18 november 2019).

European Data Protection Board

• Consultation: Guidelines 4/2019 on Article 25 Data Protection by Design and by Default (end date 16 januari 2019).

European Forum for Good Clinical Practices

• Register to our Joint EFGCP & EFPIA multi-stakeholder discussion on Lay Summary Framework Proposal, 15 January 2020, Brussels, Belgium
• Join our EFGCP webinar on Children, Young People and Families Involvement in Drug Development & Innovation — 16 December 2019, 17:00-18:00 CET

European Medicines Agency, PASS

• Latest Developments in the Transparency Activities of the European Medicines Agency (27 november 2019). BioSlice Blog, Arnold & Porter Kaye Scholer LLP.
• EMA to Implement Ombudsman’s Recommendations on Avoiding Bias (26 november 2019). Regulatory Focus.
• Presentations Workshop on draft ‘Regulatory Science to 2025’ strategy (26 november 2019).
• Does Europe s Additional Monitoring Scheme Generate Additional Evidence? (25 november 2019). Applied Clinical Trials.
• Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet (18 november 2019). Regulatory Focus.

EudraLex, ECTD, ECTR

• Europese verordening 536/2014 betreffende klinische proeven met geneesmiddelen (ECTR)
  • EC Explains What it Means to Authorize Clinical Trials With Conditions (2 december 2019). Regulatory Focus.
  • Informed consent and patient recruitment procedure template (Eudralex Volume 10 – Clinical trials guidelines – Set of documents applicable to clinical trials under Regulation EU No 536/2014) (gepubliceerd 28 november 2019). Europese Commissie.
  • Draft Questions and Answers Document (Version 2.3) (Eudralex Volume 10 – Clinical trials guidelines – Set of documents applicable to clinical trials under Regulation EU No 536/2014) (released 28 november 2019).
• Europese richtlijn 2001/20/EC betreffende klinische proeven (ECTD)
  • Updated document – Annex 1 of the Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (gepubliceerd 28 november 2019). Europese Commissie.

Experimentele behandeling of medisch-wetenschappelijk onderzoek?

• Artificial womb technology and clinical translation: Innovative treatment or medical research? (29 november 2019). Bioethics.

Gentherapie

• Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine (22 november 2019). FDA Law Blog, Hyman, Phelps & McNamara PC.

Good Manufacturing Practice

• PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management (2 december 2019). Regulatory Focus.
  

Humane genome editing, Germline editing

• AMA Journal of Ethics. Governing Human Genome Editing (December 2019).
• China gene-edited baby experiment ‘may have created unintended mutations’ (4 december 2019). The Guardian.
• A genome editing month (26 november 2019). Nuffield Council on Bioethics.
• Human germline genome editing (4 december 2019). Nature Cell Biology.
• Russia’s stance on human genome editing (26 november 2019). Nature.
• Designing Preclinical Studies in Germline Gene Editing: Scientific and Ethical Aspects (21 november 2019). Journal of Bioethical Inquiry.
• Genetically-modified babies ‘ethically justifiable’, academic claims (19 november 2019). BBC News.

International Council on Harmonization

• ICH Overhauls 22-Year-Old Clinical Studies Guideline (24 november 2019). CenterWatch.

Medische hulpmiddelen, Europese verordening 2017/745 betreffende medische hulpmiddelen

• For medical device start-ups: A brief guide to CE mark (3 december 2019). Maria Nyåkern via LinkedIn.
• Eudamed’s 2-Year Delay: CAMD Executive Group Calls for Interim Solutions (2 december 2019). Regulatory Focus.
• Klinische evaluatie – de definities (25 november 2019). Quality Business Support Blog.
• Oplevering Eudamed vertraagd (24 november 2019). Quality Business Support Blog.
• Eudamed delayed, but MDR not delayed – now what? (19 november 2019). Medicaldeviceslegal.

Office for Human Research Protections

• How is Medical Research Different from Medical Care? (7 november 2019). Via YouTube [kijktijd: 5 min & 43 sec].

Psychiatric genetic research

• Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups (19 november 2019). Ethics & Human Research.

Repurposing

• FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases (5 december 201). FDA.

Research misconduct, MREC approval

• Psycholoog Universiteit Leiden schond vele normen (6 december 2019). NRC.
  • Advies Commissie Wetenschappelijk Integriteit, Universiteit Leiden (11 november 2019).
• Psychology researcher committed misconduct, says university (5 december 2019). Retraction Watch.
• Researchers’ perceptions of research misbehaviours: a mixed methods study among academic researchers in Amsterdam (2 december 2019). Research Integrity and Peer Review
• Tri-Cities researcher made $5.6M from fake drug trials. Now he faces life in prison(29 november 2019). Tri-City Herald.

Safety information

• Ask the Expert: Examining and Reporting Safety Information (15 november 2019). CenterWatch.

U.S. Food and Drug Administration

• FDA Drafts Recommendations for IC/BSP Drug Development (4 december 2019). Regulatory Focus.
• FDA Debates Creating Pilot to Evaluate Novel Excipients (4 december 2019). Regulatory Focus.
• FDA Finalizes Guidance on Adaptive Trial Designs (2 december 2019). Regulatory Focus.
• FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables (25 november 2019). Regulatory Focus.
• Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient (25 november 2019).
• Recently Posted Guidance Documents
  • Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry (29 november 2019).
  • Draft Guidance: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products (27 november 2019).

Wijziging Wet medisch wetenschappelijk onderzoek met mensen

• IGJ ook zonder toestemming toegang tot medische gegevens (18 november 2019). Van Doorne.

World Health Organization, Data integrity guideline

• WHO Drafts Guideline on Data Integrity for Pharmaceuticals (19 november 2019). Regulatory Focus.

Overig nieuws

• The Transformation of Digital Health: What it Means for Regulatory Professionals (2 december 2019). Regulatory Focus.
• Innovative Stem Cell-Gene Therapies Hold the Key for Effective & Affordable Cancer Treatments (2 december 2019). Applied Clinical Trials.
• Comparing Skype (video calling) and in-person qualitative interview modes in a study of people with irritable bowel syndrome – an exploratory comparative analysis (29 november 2019). BMC Medical Research Methodology.
• Emerging Digital Health Solutions: Inherent Challenges in the Technology Driven World (27 november 2019). Regulatory Focus.
• Latest View on Health Claims on Foods in the EU (26 november 2019). BioSlice Blog, Arnold & Porter.
• Africa should set its own health-research agenda (26 november 2019). Nature.
• R&D in Hard-to-Treat Fungal Infections Advances (26 november 2019). Apllied Clinical Trials.
• Developing Digital Drug Information Based on Real World Effectiveness Tests: What Patients Really Need(26 november 2019). Regulatory Focus.
• Invest-NL is een feit (26 november 2019). HollandBIO.  
• Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed (24 november 2019). CenterWatch.
• The Challenges of Sharing Data in an Era of Politicized Science (21 november 2019). JAMA.
• A review and synthesis of frameworks for engagement in health research to identify concepts of knowledge user engagement (21 november 2019). BMC Medical Research Methodology.
• Donors, authors, and owners: how is genomic citizen science addressing interests in research outputs? (21 november 2019). BMC Medical Ethics.
• ‘Reproducibility crisis’ in radiation biology research could negatively impact clinical care advances (20 november 2019). Healio.
• Disaster-zone research needs a code of conduct (20 november 2019). Nature.
• A new treatment promises to make little people taller. Is it an insult to ‘dwarf pride’? (18 november 2019). STAT.
• De OODA-loop als alternatief voor PDCA (17 november 2019). Quality Business Support Blog.

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Recent verschenen

• Overzicht bijeenkomsten & consultaties (1 December 2019)
• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 100 (4 november 2019)

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Meer actueel nieuws en andere ontwikkelingen vindt u op news.bontrop.com! (nu met vernieuwde nieuwsfeed)

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