Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative. [PDF]
, 2018 Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed.
Benjamin, Daniel K +11 more
core +5 more sources
Prototype of running clinical trials in an untrustworthy environment using blockchain. [PDF]
, 2019 Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system.
Bhattacharya, Sanchita +2 more
core +3 more sources
Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned [PDF]
, 2017 Background Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the ‘gold standard’ management system developed for managing diverse ...
Michael, Mary J. +2 more
core +2 more sources
Comparison of Bayesian and frequentist group-sequential clinical trial designs [PDF]
, 2020 Background: There is a growing interest in the use of Bayesian adaptive designs in late-phase clinical trials. This includes the use of stopping rules based on Bayesian analyses in which the frequentist type I error rate is controlled as in frequentist
Gates, Simon +3 more
core +2 more sources
Reply - Letter to the Editor - Malnutrition: The kiss of grim reaper [PDF]
, 2016 Conducting a large, multicenter, prospective, randomized clinical trial poses a number of challenges. In particular, the successful completion of the trial is based on devising a protocol which could yield to clinically relevant answers yet no becoming
Laviano, Alessandro
core +1 more source
Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial : study protocol for a randomized controlled trial [PDF]
, 2012 Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure.
A Mercat +31 more
core +1 more source
Impact of sitagliptin on endometrial mesenchymal stem-like progenitor cells : a randomised, double-blind placebo-controlled feasibility trial [PDF]
, 2020 Background: Recurrent pregnancy loss (RPL) is associated with the loss of endometrial mesenchymal stem-like progenitor cells (eMSC). DPP4 inhibitors may increase homing and engraftment of bone marrow-derived cells to sites of tissue injury.
Brighton, Paul (Paul J.) +13 more
core +1 more source
Stroke treatment academic industry roundtable recommendations for individual data pooling analyses in stroke [PDF]
, 2016 Pooled analysis of individual patient data from stroke trials can deliver more precise estimates of treatment effect, enhance power to examine prespecified subgroups, and facilitate exploration of treatment-modifying influences.
Khatri, Pooja +2 more
core +1 more source
Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]
, 2005 Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
core +3 more sources
Decision aids can support cancer clinical trials decisions: Results of a randomized trial [PDF]
, 2016 BACKGROUND. Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center’s website. METHODS.
Byrne, Margaret M +5 more
core +2 more sources