Uitgelicht en gespot op internet (week 34, 35 & 36)

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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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Adverse events

• Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events (5 september 2019). Trials, volume 20, Article number: 553.

AVG, GDPR

• Antwoord op vragen van de leden Ploumen en Kerstens over het gebrekkige toezicht op de data van patiënten (5 september 2019). Minister voor Medische Zorg.
• When Apps Get Your Medical Data, Your Privacy May Go With It (3 september 2019). The New York Times.
• GDPR Brief: The Data Protection Impact Assessment and Genomic Health Research (2 september 2019). Global Alliance for Genomics & Health.
• Stand van zaken zaken GDPR Code of Conduct for Health Research (31 augustus 2019). Nieuwsbrief voor Goede Onderzoekspraktijken nr. 97.
• Stand van zaken Federa Gedragscode gezondheidsonderzoek (31 augustus 2019). Nieuwsbrief voor Goede Onderzoekspraktijken nr. 97.
• The Five Safes of Risk-Based Anonymization (30 augustus 2019). IEEE Security & Privacy ( Volume: 17 , Issue: 5 , Sept.-Oct. 2019 ).

Brexit

• White paper on medical devices in relation to a no deal Brexit (updated 8 juli 2019). Ministry of Health, Welfare and Sport.

cOAlition S

• WHO joins coalition for free digital access to health research (29 augustus 2019). WHO.

Clinical trials

• Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial (28 augustus 2019). Trials, volume 20, Article number: 532.
• Putting Placebo Response in Its Place (26 augustus 2019). CenterWatch.
• Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival (23 augustus 2019). Trials, volume 20, Article number: 527 (2019).
• Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial (23 augustus 2019). Trials, volume 20, Article number: 525 (2019).
• Investigating causal mechanisms in randomised controlled trials (23 augustus 2019). Trials, volume 20, Article number: 524 (2019).
• Umbrella and basket trials in oncology: ethical challenges (23 augustus 2019). BMC Medical Ethics, volume 20, Article number: 58 (2019).
• Clinical trial data reuse – overcoming complexities in trial design and data sharing (19 augustus 2019). Trials, volume 20, Article number: 513 (2019).
• Childhood obesity intervention studies: A narrative review and guide for investigators, authors, editors, reviewers, journalists, and readers to guard against exaggerated effectiveness claims (19 augustus 2019). Obesity Reviews.
• Mobile e‐diary application facilitates the monitoring of patient‐reported outcomes and a high treatment adherence for clinical trials in dermatology (16 augustus 2019). Journal of the European Academy of Dermatology and Venereology.
• UCLH launches open clinical trial discovery platform (15 augustus 2019). Digital Health.

Clinical trials registry

• An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India (28 augustus 2019). Trials, volume 20, Article number: 535.

Clinical trial results reporting

• UK parliament demands sanctions for clinical trial non-reporting (25 augustus 2019). TranspariMED.
•  Patient groups demand sanctions on those who fail to report clinical trial results (20 augustus 2019). TranspariMED.

Clinical Trials Transformation Initiative

• CTTI Unveils New Resources to Facilitate Implementation of Single IRB for Multicenter Trials (3 september 2019).

European Medicines Agency

Global public meeting on draft ICH guideline on clinical trials (30 augustus 2019).

Feasibility

• Preparing for Success: A Better Way to Manage the Feasibility Process (2 september 2019). CenterWatch.

Gentherapie, Germline gene editing

• Integrating expert opinion with clinical trial data to extrapolate long-term survival: a case study of CAR-T therapy for children and young adults with relapsed or refractory acute lymphoblastic leukemia (2 september 2019). BMC Medical Research Methodology, volume 19, Article number: 182.
• Intergenerational monitoring in clinical trials of germline gene editing. Journal of Medical Ethics Published Online First: 31 August 2019.

Informed consent, Participation, Recruitment, Representatief

• Calculating reimbursement rates for patient engagement in medicines development (3 september 2019). Patient Focused Medicines Development.
• Consider Patients’ Attitudes When Designing Benefit-Risk Communications (2 september 2019). CenterWatch.
• Methods of identifying and recruiting older people at risk of social isolation and loneliness: a mixed methods review (29 augustus 2019). BMC Medical Research Methodologyvolume 19, Article number: 181.
• FDA encourages male participation in breast cancer clinical trials (28 augustus 2019). Outsourcing-Pharma.
• Updating Patient Consent Practices Could Enhance Research (26 augustus 2019). LexBlog.
• Community engagement is key to clinical trial recruitment and diversity (23 augustus 2019). STAT.
• Many clinical trials for new cancer drugs didn’t include any data on race (19 augustus 2019). STAT.
• Minority racial groups continue to be dismally represented in cancer trials — study (19 augustus 2019). Endpoints News.
• Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda (19 augustus 2019). mHealth.
• Neuroimaging’s Bias Against Left-handers (17 augustus 2019). Discover.
• How Payment for Research Participation Can Be Coercive (16 augustus 2019). The American Journal of Bioethics.
• Report Defining stakeholders’ preferences, needs and expectations. PARADIGM.
  • Summary Defining stakeholders’ preferences, needs and expectations. PARADIGM.
• Harms From Uninformative Clinical Trials. JAMA. Published online July 25, 2019322(9):813–814. doi:10.1001/jama.2019.9892

Kind en onderzoek

• ModelPIF voor 12-16 jaar oud en bespreekblad tot 12 jaar.
  • Nieuw Patient Informatie Formulier voor kinderen, via LinkedIn.

Medical Research Council

• Guidance Note 5: Identifiability, anonymisation and pseudonymisation (augustus 2019).

Medische hulpmiddelen

• IGJ publiceert instellingsrapport klinisch onderzoek met medische hulpmiddelen Maastricht UMC+ (31 augustus 2019). Nieuwsbrief voor Goede Onderzoekspraktijken nr. 97.
• ANSM publiceert ‘Practical Information Guide for Applicants: Medical Device Clinical Investigations Submitted to the ANSM and Ethics Committee within the Pilot Phase’ (31 augustus 2019). Nieuwsbrief voor Goede Onderzoekspraktijken nr. 97.

New drug applications

• Enough with the me-too drugs. New treatments should be worthy of the people who invest their lives in clinical trials (4 september 2019). STAT.
• EMA and FDA historically agree on just about every new drug approval, but is that slowly changing? (19 augustus 2019). Endpoints News.

Pediatrisch onderzoek

• Challenges and Priorities for Pediatric Palliative Care Research in the United States and Similar Practice Settings: Report from a Pediatric Palliative Care Research Network Workshop. Journal of Pain and Symptom Management.

NHS Health Research Authority: gdpr, study set-up & delivery

• Update to data transparency wording (2 september 2019).
• Sharing anonymised patient-level data where there is a mixed public and private benefit – a new report (1 september 2019).
• Launch of the UK Local Information Pack: supporting the set-up of NHS/HSC research in the UK (4 juni 2019).

Organoids

• In a first, cerebral organoids produce complex brain waves similar to newborns’, reviving ethical concerns (29 augustus 2019). STAT.

Orphan

• They rallied around ‘our boys’ as they pushed for a Duchenne cure. Where did that leave girls? (26 augustus 2019). STAT.

Society for Clinical Data Management

• New SCDM Reflection Paper details the Industry Transformation from Clinical Data Management to Clinical Data Science (5 september 2019).

Risk-Based Monitoring

• Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials (16 augustus 2019). ACRO.
• Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations (18 juli 2019). Duke Margolis, via YouTube [kijktijd 6 uur]

Real-world evidence, Real-world data

• Former FDA Commissioners Call for Expanded Use of Real-World Evidence (26 augustus 2019). CenterWatch.

Registered reports

• Practical Considerations for Navigating Registered Reports. Trends in Neurosciences, Volume 42, Issue 9, September 2019, Pages 568-572.

Research assistants

• Recognizing the Role of Research Assistants in the Protection of Participants in Vulnerable Circumstances (30 augustus 2019).  Journal of Empirical Research on Human Research Ethics.

Retractions

• “Questioned as implausible:” Journal retracts paper because a researcher claimed to perform a large clinical trial single-handedly (4 september 2019). Retraction Watch.

Subgroups

• Statistical approaches to identify subgroups in meta-analysis of individual participant data: a simulation study (2 september 2019). BMC Medical Research Methodology, volume 19, Article number: 183.

TransCelerate

• DMC Registry Concept

U.S. Food and Drug Administration

• FDA Issues Guidance on Placebo-Controlled Design in Hematologic, Oncology Trials (3 september 2019). ACRP.
• FDA Finalizes Guidance on Placebos and Blinding for Cancer Trials (28 augustus 2019). Regulatory Focus.
• Industry Seeks More Detail from FDA Guidance on Trial Diversity (19 augustus 2019). CenterWatch.
• FDA Proposes Endpoints for Gastroparesis Trials (19 augustus 2019). CenterWatch.
• Recently Posted Guidance Documents
  • Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry (5 september 2019).

Overig nieuws

• Applied Clinical Trials July/August 2019
• Journal of Clinical Research Best Practices
• Keeping a clean research environment: Addressing research misconduct and improving scientific integrity in China. Cancer Letters, Volume 464, 1 November 2019, Pages 1-4.
• Two Reasons Why Big Pharma Companies Like Novartis And Bayer Run Their Clinical Trial Planning Internally (3 september 2019). Maya Zlatanova, via LinkedIn.
• Interval-cohort designs and bias in the estimation of per-protocol effects: a simulation study (5 september 2019). Trials, volume 20, Article number: 552.
• Over half of all US/EU regulator warnings issued to Indian and Chinese manufacturers, report finds (28 augustus 2019). Pharmafile.
• Funders Have Given Facebook A Deadline To Share Data With Researchers Or They’re Pulling Out (27 augustus 2019). BuzzFeed News.
• Study builds roadmap for collecting, sequencing genetic data (22 augustus 2019). Baylor College of Medicine.
• Inside a Brain Bank, Where Humans’ Most Precious Organ Is Dissected and Studied (21 augustus 2019). Smithsonian.
• Scientists routinely cure brain disorders in mice but not us. A new study helps explain why (21 augustus 2019). STAT.
• Top scientist categorically denies any wrongdoing in Novartis data manipulation scandal (19 augustus 2019). STAT.
• Teaching Vulnerability in Research: A Study of Approaches Utilized by a Sample of Research Ethics Training Programs (17 augustus 2019). Journal of Empirical Research on Human Research Ethics.
• Why Ethically Reflect on Empirical Studies in Empirical Ethics? (8 augustus 2019). Journal of Empirical Research on Human Research Ethics.
• Personal Genetic Information about HIV: Research Participants’ Views of Ethical, Social, and Behavioral Implications. Public Health Genomics.

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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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