Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective
Sign Up to like & getrecommendations! Published in 2018 at "Medicine, Health Care and Philosophy"
DOI: 10.1007/s11019-017-9782-1
Abstract: This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to… read more here.
Keywords: research; trial; access healthcare; post trial ... See more keywords
Review of the veteran affairs diabetes trial: Lessons learned
Sign Up to like & getrecommendations! Published in 2020 at "Reviews in Endocrine and Metabolic Disorders"
DOI: 10.1007/s11154-020-09558-5
Abstract: Despite robust evidence linking long-term hyperglycemia with cardiovascular complications, several large randomized trials found only modest benefits from intensive compared to standard glucose control. Of these trials, the Veteran Affairs Diabetes Trial (VADT), offers a… read more here.
Keywords: trial; affairs diabetes; post trial; veteran affairs ... See more keywords
Medial prefrontal cortex ERK and conditioning: Evidence for the association of increased medial prefrontal cortex ERK with the presence/absence of apomorphine conditioned behavior using a unique post-trial conditioning/extinction protocol
Sign Up to like & getrecommendations! Published in 2019 at "Behavioural Brain Research"
DOI: 10.1016/j.bbr.2019.02.022
Abstract: &NA; Increases in medial prefrontal cortex ERK have been linked to learning and memory processes. In the present study separate groups of rats initially underwent testing in an open‐field paired with either 2.0 mg/kg apomorphine… read more here.
Keywords: medial prefrontal; apomorphine; response; post trial ... See more keywords
Estimated legacy effects from simulated post-trial data were less biased than from combined trial/post-trial data.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of clinical epidemiology"
DOI: 10.1016/j.jclinepi.2019.05.010
Abstract: OBJECTIVES "Legacy effects" describe the phenomena where treatment effects are apparent during the post-trial period that are not attributable to the direct effects observed within the trial. We investigate different approaches to analysis of trial… read more here.
Keywords: post trial; legacy effects; trial; trial data ... See more keywords
Drugs and memory: Evidence that drug effects can become associated with contextual cues by being paired post-trial with consolidation/re-consolidation. Mini review
Sign Up to like & getrecommendations! Published in 2020 at "Pharmacology Biochemistry and Behavior"
DOI: 10.1016/j.pbb.2020.172911
Abstract: An extensive literature has validated the critical importance of a brief post-trial consolidation period for the incorporation of an experience into memory. Importantly, during this active consolidation state the memory formation is vulnerable to modification.… read more here.
Keywords: drug; post trial; consolidation; trial consolidation ... See more keywords
Situating Empirical Bioethics in Discussions of Post-Trial Responsibility
Sign Up to like & getrecommendations! Published in 2022 at "AJOB Neuroscience"
DOI: 10.1080/21507740.2022.2126543
Abstract: There is a growing recognition that the ongoing use of investigational neural implants requires continued access to clinical expertise and specialized healthcare (e.g., Hendriks et al., 2019). However, there is little consensus amongst clinical trial… read more here.
Keywords: discussions post; dbs; post trial; trial ... See more keywords
Leaving Users in the Dark: A Call to Define Responsibilities toward Users of Neural Implanted Devices
Sign Up to like & getrecommendations! Published in 2022 at "AJOB Neuroscience"
DOI: 10.1080/21507740.2022.2126545
Abstract: Sankary et al. (2022) report the results of an empirical study on research participant experiences of exiting research at the end of clinical trials of deepbrain-stimulation (DBS) and responsive neurostimulation (RNS), in which they discuss… read more here.
Keywords: implanted devices; post trial; trial; sankary 2022 ... See more keywords
Brain Device Research and the Underappreciated Role of Care Partners before, during, and Post-Trial
Sign Up to like & getrecommendations! Published in 2022 at "AJOB Neuroscience"
DOI: 10.1080/21507740.2022.2126548
Abstract: No 1223/2009 and repealing Council Directives 90/385/ EEC and 93/42/EEC (europa.eu) Sankary, L. R., M. Zelinsky, A. Machado, T. Rush, A. White, and P. J. Ford. 2022. Exit from brain device research: A modified grounded… read more here.
Keywords: brain device; post trial; brain; research ... See more keywords
POS1497-PARE POST-TRIAL SURVEY OF PARTICIPANTS OF A PHASE 3 CLINICAL TRIAL IN SSC-ILD
Sign Up to like & getrecommendations! Published in 2021 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2021-eular.1847
Abstract: The SENSCIS® trial (2015–18) was a large clinical trial (n=576) investigating the efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease.1 The clinical research sponsors (CRS) collaborated with the scleroderma patient… read more here.
Keywords: clinical trials; trial survey; trial; survey ... See more keywords
Legacy effects of statins on cardiovascular and all-cause mortality: a meta-analysis
Sign Up to like & getrecommendations! Published in 2018 at "BMJ Open"
DOI: 10.1136/bmjopen-2017-020584
Abstract: Objectives To assess evidence for ‘legacy’ (post-trial) effects on cardiovascular disease (CVD) mortality and all-cause mortality among adult participants of placebo-controlled randomised controlled trials (RCTs) of statins. Design Meta-analysis of aggregate data. Setting/Participants Placebo-controlled statin… read more here.
Keywords: cause mortality; legacy effects; post trial; mortality ... See more keywords
Post-trial provisions in the Declaration of Helsinki: a watered-down principle that needs to be strengthened
Sign Up to like & getrecommendations! Published in 2022 at "Journal of the Royal Society of Medicine"
DOI: 10.1177/01410768221133567
Abstract: The Declaration of Helsinki (DoH) states that the ethical principles that the World Medical Association (WMA) considers should guide all clinical research involving human subjects. The moral authority of the DoH has been recognised internationally,… read more here.
Keywords: post trial; trial provisions; trial; declaration helsinki ... See more keywords