Uitgelicht en gespot op internet (week 37 & 38)

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‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

Uitgelicht & Gespot op Internet

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Biobanken, Organoids

• The Ethics of Cerebral Organoid Research: Being Conscious of Consciousness (10 september 2019). Stem Cell Reports.
• Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear (6 september 2019). The Oncologist.
• Navigating the moral maze of open-ended data collection (28 augustus 2019). BBMRI.nl.
  • Proefschrift Martin Boeckhout The Ethics and Governance of Health Research Infrastructure (2019).
• Opportunities of national screening programs for scientific research (7 augustus 2019). Health-RI.

Brexit

• Industry needs ‘practical details’ to respond to hard Brexit (13 september 2019). Outsourcing-Pharma.com

Centrale Commissie Mensgebonden Onderzoek

• Model onderzoekscontract beschikbaar voor onderzoeker-geïnitieerd onderzoek (20 september 2019).
• Nieuwe versie Investigational Medical Device Dossier (IMDD) beschikbaar (20 september 2019).

Clinical trials

• A Bayesian non-inferiority approach using experts’ margin elicitation – application to the monitoring of safety events (18 september 2019). BMC Medical Research Methodology, volume 19, Article number: 187 (2019).
• The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial (18 september 2019). Trials, volume 20, Article number: 570 (2019).
• Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols (18 september 2019). Trials, volume 20, Article number: 572 (2019).
• A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials (18 september 2019). Trials, volume 20, Article number: 571 (2019).
• Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume? (13 september 2019). Trials, volume 20, Article number: 566 (2019).
• EU cancer group calls for better cross-border access to clinical trials (13 september 2019). The Parliament.
• Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis BMJ 2019; 366 :l522.
• The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018 (10 september 2019). PLOS Medicine 16(9): e1002873.
  • Cancer trials aimed at ‘surrogate’ targets miss bigger mark — study (19 september 2019). Endpoints News.
  • Flawed trials supported half of recent approvals of cancer drugs in Europe, study says (18 september 2019). STAT.
• Why Do Post-Marketing Drug Studies Required By The FDA Take So Long? (10 september 2019). Forbes.
• Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis. JAMA Netw Open. Published online August 30, 20192(8):e199570.
• Less clinical trials without merit, please (18 augustus 2019). Matt Maxwell, via LinkedIn.

Clinical trial results reporting, Positive outcomes, Bias, Registered Reports, Study plans

• The effects of industry funding and positive outcomes in the interpretation of clinical trial results: a randomized trial among Dutch psychiatrists (18 september 2019). BMC Medical Ethics, volume 20, Article number: 64 (2019).
• What’s next for Registered Reports? (10 september 2019). Nature.
• Chair responds to open letter calling for sanctions for non-compliance with clinical trials reporting requirements (23 augustus 2019). Parliament.UK, Science and Technology Committee (Commons).
• Iqvia launches patient portal that provides trial participants with study updates, outcomes (15 augustus 2019). Outsourcing Pharma.

CRISPR

• Pros and cons of genetic scissors (19 september 2019). Bionity.com
• Could editing the DNA of embryos with CRISPR help save people who are already alive? (16 september 2019). STAT.
• First CRISPR editing trial results assuage safety concerns (11 september 2019). Nature Medicine.
• Reproductive CRISPR does not cure disease (6 september 2019). Bioethics.
• Het DNA van embryo’s aanpassen, willen we dat eigenlijk wel? De DNA-Dialoog gaat van start (6 september 2019). Kennislink.

Data integrity

• Novartis makes new data integrity commitment (9 september 2019). Endpoints News.
• Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future (9 september 2019). STAT.

Data Monitoring Committees, Endpoint Adjudication Committees

• Expert Committees Need Expert Management (8 september 2019). CenterWatch.

Dierexperimenteel onderzoek

• Animal registries aim to reduce bias (9 september 2019). Nature.

Drug approval

• A reality check of the accelerated approval of immune-checkpoint inhibitors (5 augustus 2019). Nature Reviews.

Dutch Clinical Research Foundation

• ‘Document X’ wordt Verklaring Geschiktheid Onderzoeksinstelling (16 september 2019).
• Wees een van de eersten die de details van de ECTR kent! (16 september 2019).
• Vaststelling Eind- en Toetstermen GCP-WMO examen (10 september 2019).

Inclusie, Informed consent, Participatie, Recruitment

• This patient group boosted women enrollees in health study as part of joint effort with Alphabet’s Verily (19 september 2019). MM&M.
• Millennial Expectations Poised to Upend Clinical Trial Recruitment (18 september 2019). ACRP.
• ‘Everything to do with patient centricity’: Wearables to redefine research approaches (11 september 2019). Outsourcing Pharma.
• Nieuw: Kickstarter patiëntenparticipatie bij onderzoek (9 september 2019). ZonMw.
  • Kickstarter voor onderzoekers. Participatiekompas.
• The moral imperative to approve pregnant women’s participation in randomized clinical trials for pregnancy and newborn complications (6 september 2019). Philosophy, Ethics, and Humanities in Medicine, volume 14, Article number: 11 (2019).
• Deferred consent for delivery room studies: the providers’ perspective
  Archives of Disease in Childhood – Fetal and Neonatal Edition Published Online First: 19 August 2019. doi: 10.1136/archdischild-2019-31728
• The New Era Of Informed Consent (26 april 2019). Eye for Pharma.

Medicines and Healthcare products Regulatory Agency

• Clinical trials data for medicines (updated 20 september 2019).

Medische hulpmiddelen

• Increased clinical evidence demands for medical devices in EU more or better? (17 september 2019). Medical Devices Clinical.

Pediatrisch onderzoek

• Website voor jeugdige onderzoekdeelnemers uitgebreid (3 september 2019). ZonMw.
• Promoting Pediatric Drug Research and Labeling — Outcomes of Legislation (29 augustus 2019). NEJM.

Peer review

• Ask The Chefs: Peer Review Quality (12 september 2019). The Scholary Kitchen.

Privacy, Health data ethics, Personal genomics

• Data privacy in the age of personal genomics (19 september 2019). Nature Biotechnology.
• Millions of Americans’ Medical Images and Data Are Available on the Internet. Anyone Can Take a Peek. (17 september 2019). ProPublica.
• Despite Regulations, Heart Failure Trials Results are Infrequently Published (14 september 2019). MD Magazine.
• ‘There’s no such thing as anonymity’: With consumer DNA tests, sperm banks reconsider long-held promises to donors (11 september 2019). STAT.
• How Should Scientists’ Access To Health Databanks Be Managed? (6 september 2019). NPR.
• ASHG asserts core genetic data privacy principles for all research and funding arenas (5 september 2019). EurekAlert.
• GDPR Brief: The Data Protection Impact Assessment and Genomic Health Research (2 september 2019). Global Alliance for Genomics & Health.
• Health Data Ethics Map. Visualizes the complexity of inter-connected health data responsibilities and rights. The map is based upon the Swiss Personalized Health Network’s”Ethical Framework for Responsible Data Processing in Personalized Health Research.

Risk based montoring

• An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units (10 september 2019). Trials, volume 20, Article number: 556 (2019).

Society for Clinical Data Management

• The Evolution of Clinical Data Management to Clinical Data Science: A Reflection Paper on the impact of the Clinical Research industry trends on Clinical Data Management.

TransCelerate

• Patient Experience Initiative: The Patient Protocol Engagement Toolkit (P-PET) and the Study Participant Feedback Questionnaire Toolkit (SPFQ).
• Data Monitoring Committee (DMC) Proposed Registry Overview & Guide.

U.S. Food and Drug Administration

• Draft Guidance for Industry: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products (20 september 2019).
• FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making (29 augustus 2019).

World Health Organization

• WHO launches global registry on human genome editing (29 augustus 2019).

Overig nieuws

• Drug Discovery Today, Volume 24, Issue 9, Pages 1701-1954, September 2019.
• Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US (18 september 2019). Frontiers in Pharmacology.
• ‘Right to Try’ twin startups, Trump’s claims stir confusion, bioethicists say (17 september 2019). S&P Global.
• Stem Cell Businesses and Right to Try Laws (6 september 2019). Cell Stem Cell.
• Drugmakers Support FDA’s Expanded Trial Eligibility Plan, GAO Says (16 september 2019). CenterWatch.
• The Ninth International Congress on Peer Review and Scientific PublicationA Call for Research (16 september 2019). JAMA.
• Ask the Expert: Protocol Deviations and Publishing Case Studies (16 september 2019). CenterWatch.
• Embryo-like structures created from human stem cells (16 september 2019). Nature.
• Many cancer drugs aim at the wrong molecular targets (11 september 2019). Nature.
• Off-target toxicity is a common mechanism of action of cancer drugs undergoing clinical trials (11 september 2019). Science Translational Medicine.
• A Famous Argument Against Free Will Has Been Debunked (10 september 2019). The Atlantic.
• Clinical Research and Clinical Care: Carving a New Approach (8 september 2019). CenterWatch.
• If you think p-values are problematic, wait until you understand Bayes Factors (6 september 2019). Data Colada.
• Workflow systems turn raw data into scientific knowledge (2 september 2019). Nature.
• A systematic breakdown of the levels of evidence supporting the European Society of Cardiology guidelines (14 augustus 2019). European Journal of Preventive Cardiology.
• UK’s plan for ‘mandatory’ research ethics training dropped. Times Higher Education.
• Kunstmatige intelligentie in zeven kritische aandachtspunten (1 juli 2019). Medisch Contact.
• Reflections on the Evolution of Patient Engagement in Drug Development (17 mei 2019). Pharmaceutical Medicine.

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Recent verschenen

• Overzicht bijeenkomsten & consultaties (1 September 2019)
• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 97 (31 augustus 2019)

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