Uitgelicht en gespot op internet (week 22)

Ook deze week een stampvol overzicht van nieuwsberichten en andere publicaties die afgelopen week door mij zijn ontvangen of gespot. Ik kan het mij niet voorstellen deze mooie, zonnige zondag, maar mocht u zich vervelen, er staan genoeg interessante berichten in de ‘Uitgelicht en gespot op internet‘ van deze week!

Dit is de vierde keer dat ik de sectie ‘Uitgelicht en gespot op internet‘ hier op mijn website plaats en niet meer in de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘ is opgenomen. Ik merk inmiddels dat door deze wijziging het aantal niet-afgeleverde nieuwsbrieven spectaculair is gedaald. Laat ik het afkloppen, maar vooralsnog zijn alle verstuurde nieuwsbrieven door de spamfilters gekomen.

Omdat ‘Uitgelicht & Gespot op internet’ een los supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘ is geworden, dienen abonnees hun abonnementsvoorkeuren bij te werken als zij ook geïnformeerd willen worden bij een nieuwe ‘Uitgelicht & Gespot op internet‘.

Heeft u nieuwstips voor het eerstvolgende overzicht? Via het contactformulier hier op de website kunt u mij uw tip toesturen.

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Biobanking

• Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? (25 mei 2019). Asian Bioethics Review.
• Biobanking in health care: evolution and future directions (22 mei 2019). Journal of Translational Medicine 2019 17:172.

Brexit

• England sees highest ever clinical trial participation rates: NIHR (28 mei 2019). Outsourcing-Pharma.com.

Clinical trials, Data management, Population health intervention research

• RTS,S malaria vaccine pilot studies: addressing the human realities in large-scale clinical trials (31 mei 2019). Trials 2019 20:316.
• Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism (30 mei 2019). Trials 2019 20:307.
• Population health intervention research: what is the place for pilot studies? (30 mei 2019). Trials 2019 20:309.
• This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols (29 mei 2019). Trials 2019 20:264.
• Mind the gap? The platform trial as a working environment (29 mei 2019). Trials 2019 20:297.
• Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons (29 mei 2019). Trials 2019 20:294.
• Market Value Should be “Defendable,” Not “Fair,” Experts Say (27 mei 2019). Center Watch.
• Lack of Training Compromises Trial Results, Expert Says (27 mei 2019). Center Watch.
• Choosing an Adaptive Over Fixed Design: Strategies and Pitfalls (23 mei 2019). BBA.

Clinical trials reporting

• What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry (27 mei 2019). Trials 2019 20:288.
• Reporting a clinical trial result on the European registry: My nightmare journey (26 mei 2019). TranspariMED.

CRISPR, Human germline editing

• 6 months later, gene-edited babies stir new interest, debate (29 mei 2019). AP.
• Would a gene-editing ban fit human-rights law? (28 mei 2019). Nature.
• Pursue Public Engagement, but Don’t Expect ‘Broad Societal Consensus’ (28 mei 2019). The Hastings Center.
• Fertility clinics around the world asked ‘CRISPR babies’ scientist for how-to help (28 mei 2019). STAT.
• How bans on germline editing deprive patients with mitochondrial disease. Nature Biotechnology (2019).
• House spending panel drops U.S. ban on gene-edited babies (24 mei 2019). Science.

Dierexperimenteel onderzoek

• Are hormones a “female problem” for animal research? (31 mei 2019). Science.
  • Seeking reform, a neuroscientist argues against ‘sexist’ beliefs that keep research focused on male animals (30 mei 2019). STAT.
• Genomics institute to close world-leading animal facility (29 mei 2019). Nature.

Ethics

• The surgeon had a dilemma only a Nazi medical text could resolve. Was it ethical to use it? (30 mei 2019). STAT.
• Ethical considerations in the use of Pernkopf’s Atlas of Anatomy: A surgical case study. Surgery, May 2019Volume 165, Issue 5, Pages 860–867.
• ‘Banished’ blood, stool samples from San Diego veterans used in research article, despite federal probe (30 mei 2019). Inewsource.
• 158 ethics violations found in research by Japan’s NCVC medical institute (30 mei 2019). The Japan Times.

Experimentel treatment, Right to try, Personalized medicine

• Tailored treatment for ALS poised to move ahead (30 mei 2019). Nature Medicine.
• When ‘right to try’ isn’t enough: Congress wants a single ALS patient to get a therapy never tested in humans (31 mei 2019). STAT.

Good Clinical Practice: Sponsor-CRO Oversight

• How to achieve a new ‘normal’ for sponsors (23 mei 2019). GCP Central.

Gedragscode gezondheidsonderzoek, Federa, COREON

• Inventarisatie herziening gedragscode gezondheidsonderzoek: Federa-COREON & Nivel.
  • Noodzaak snelle herziening Gedragscode gezondheidsonderzoek breed gedragen (23 mei 2019). NIVEL.
  • ‘Gedragscode gezondheidsonderzoek moet snel op de schop’ (24 mei 2019). Skipr.’Gedragscode gezondheidsonderzoek moet snel op de schop’
• Rapport: Inventarisatie herziening gedragscode gezondheidsonderzoek Federa-COREON & Nivel (april 2019).

Medicines and Healthcare products Regulatory Agency

• Minutes of the Stakeholder Engagement Meeting (StEM) 07 May 2019.
  • MHRA Forum: Good Clinical Practice (GCP)

Medische hulpmiddelen, Software

• Regulating Software as a Medical Device in the age of Artificial Intelligence (30 mei 2019). Regulatory Focus.

Ministerie van Volksgezondheid, Welzijn en Sport

• Kamerbrief over toekomst navelstrengbloedbank (24 mei 2019).

Open access, Plan S

• Finale versie van Plan S gepubliceerd (31 mei 2019). ZonMw.
• Plan S – ‘The best way to predict your future is to create it’ (Abraham Lincoln) (31 mei 2019). League of European Research Universities.
• Leadership – the key to Open Science success (31 mei 2019). League of European Universities.
• Ambitious open-access Plan S delayed to let research community adapt (30 mei 2019). Nature.

Patient participation

• HP&M Shares Experience with 16 Externally-Led Patient-Focused Drug Development Meetings; Summarizes Commonalities in Rare Disease Patient Perspectives in Comment to FDA (31 mei 2019). FDA Law Blog, Hyman, Phelps & McNamara PC.
• Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) (16 april 2019). Aging Clinical and Experimental Research.

Pediatric clinical trials

• Median Lag Time for First-in-Human to First-in-Child Oncology Trials (29 mei 2019). The ASCO Post.

Privacy, Big data

• Can tracking people through phone-call data improve lives? (29 mei 2019). Nature.
• Medische gegevens zijn vaak gepikt (26 mei 2019). Het Parool.

Real world evidence

• Real-world Evidence—What Does It Really Mean? JAMA Oncol. Published online May 16, 2019. doi:10.1001/jamaoncol.2019.0450

Risk-based monitoring

• A ‘best practice’: ACRO, pharma respond to FDA draft guidance as RBM adoption increases (30 mei 2019). Outsourcing-Pharma.com.

Research misconduct

• Managing research misconduct: how it is done in Europe. European Network of Research Integrity Offices.
• First publication from ENRIO: Recommendations for the Investigation of Research Misconduct. European Network of Research Integrity Offices.

Subject information & informed consent

• Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements (29 mei 2019). Trials 2019 20:301.
• Low literacy issues and the Patient Information Leaflet (15 mei 2019). KNect365.

Trial enrollment, recruitment

• Who says “no” to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program (31 mei 2019). Trials 2019 20:313.
• Unbiased data analytic strategies to improve biomarker discovery in precision medicine (31 mei 2019). Drug Discovery Today.
• Navigating trial enrollment roadblocks for underrepresented populations (30 mei 2019). Outsourcing-Pharma.com.
• Half of H.I.V. Patients Are Women. Most Research Subjects Are Men (28 mei 2019). The New York Times.
• Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium (28 mei 2019). Trials 2019 20:296.
• Ambassadors of hope, research pioneers and agents of change—individuals’ expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study (27 mei 2019). Trials 2019 20:289.
• Research and Social Media: Finding Subjects and Keeping Trust (24 mei 2019). Amp&rsand.
• FDA Addresses Health Disparities Through Communication, Research, and Collaboration (30 april 2019). FDA.

WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP)

• WHO Expert Committee on Specifications for Pharmaceutical Preparations, TRS 1019 – Fifty-third report (mei 2019).

Overig nieuws

• Physicians in the pharmaceutical industry: their roles, motivations, and perspectives (31 mei 2019). Drug Discovery Today.
• 2018 in review: FDA approvals of new molecular entities (31 mei 2019). Drug Discovery Today.
• WHO Adopts Weakened Resolution on Drug Price Transparency (28 mei 2019). Regulatory Focus.
• Regulating Clinical Innovation: Trachea Transplants and Tissue Engineering (28 mei 2019). The American Journal of Bioethics.
• FDA Should Reassess Postmarket Trials for Cancer Drugs Approved via Accelerated Pathway, Researchers Say (28 mei 2019). Regulatory Focus.
• Cancer Drugs Approved Quickly Often Fail To Measure Up Later (28 mei 2019). NPR.
• CrossFit demands retraction of paper claiming their participants are more likely to be injured (28 mei 2019). Retraction Watch.
• [77] Number-Bunching: A New Tool for Forensic Data Analysis (25 mei 2019). Datacolada.
• After GWAS studies, how to narrow the search for genes? (21 mei 2019). EurekAlert.
• Drug Regulators Look to Harmonize How They Tackle Innovation (21 mei 2019). Regulatory Focus.
• The Role of Inclusion Benefits in Ethics Committee Assessment of Research Studies (20 mei 2019). Ethics & Human Research.
• Academia and industry: allocating credit for discovery and development of new therapies (20 mei 2019). J Clin Invest. 2019. 
• The Ariane-IPF ERS Clinical Research Collaboration: seeking collaboration through launch of a federation of European registries on idiopathic pulmonary fibrosis. European Respiratory Journal.

Ook interessant

• Domeinnamen in de zorg alsnog geregistreerd na Samen Veilig-datalek(29 mei 2019). RTV Utrecht.

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