Results 51 to 60 of about 41,551 (186)

The International Council for Harmonisation E6 (R3) revision and its impact on clinical research practice: A narrative review

Cancer Research, Statistics, and Treatment
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established in April 1990, has released an updated version of its ICH E6 guidelines for Good Clinical Practice (GCP). This new version, ICH E6 (
Bhavesh A P Bandekar, Akriti Sood, Gargi Ganguly, Natasha Sisodia, Soumitra Saha, Akhil Kapoor, Satyajit Pradhan   +6 more
doaj   +1 more source

Selection bias in clinical stroke trials depending on ability to consent

BMC Neurology, 2017
Background Clinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent.
Benjamin Hotter, Lena Ulm, Sarah Hoffmann, Mira Katan, Joan Montaner, Alejandro Bustamante, Andreas Meisel   +6 more
doaj   +1 more source

Data monitoring committees: Promoting best practices to address emerging challenges

, 2017
Background and Purpose: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials.
David L DeMets, Susan S Ellenberg, Janet Wittes, Thomas R Fleming, David J Gordon, Matthew T Roe, Marvin A Konstam, Gail D Pearson, Alan Meisel, Raymond P Bain, Michael J Pencina, James D Neaton, Karim A Calis, Marc A Pfeffer, Charles H Hennekens, Kenneth W Mahaffey, Amit N Vora, Tomas LG Andersson   +17 more
core   +1 more source

Pharmacovigilance during mass immunization campaign with MenAfrivac τm in Cameroon [PDF]

, 2015
Background. Immunization is one of the most cost effective public health interventions and is estimated to have greatly reduced diseases, disabilities, deaths, and inequities worldwide.
Ateudjieu, Jerome
core   +1 more source

Comparison of the completed and discontinued pediatric drug clinical trials in Mainland China: a cross-sectional analysis based on the data from 2003 to 2023

BMC Pediatrics
Background Pediatric drug clinical trials are essential for ensuring the accessibility and safety of medications intended for children. In recent years, the Chinese government has implemented various measures to foster the development of pediatric drug ...
Zi-Ming Wang, Rui-Rui Du, Li Yang
doaj   +1 more source

Data Monitoring Committees: Current issues

, 2018
Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study ...
David L DeMets, Susan S Ellenberg, Thomas R Fleming   +2 more
core   +1 more source

Challenging Issues in Clinical Trial Design: Part 4 of a 4-Part Series on Statistics for Clinical Trials. [PDF]

, 2015
As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring ...
Clayton, Tim C, Pocock, Stuart J., Stone, Gregg W., Pocock, Stuart J, Clayton, Tim C., Stone, Gregg W   +5 more
core   +1 more source

ESTADO DEL ARTE EN LAS REVISTAS MÉDICAS EN EL SIGLO XXI

Revista Médica Clínica Las Condes, 2019
Resumen: Las revistas médicas publican manuscritos médicos científicos, verifican su autenticidad, diseminan su contenido y lo archivan. Ello las convierte en reflejos del estado actual de la medicina, repositorios de experiencias clínicas, vías de ...
Humberto Reyes
doaj   +1 more source

CONSIDERACIONES ÉTICAS EN EL PROCESO DE UNA PUBLICACIÓN CIENTÍFICA

Revista Médica Clínica Las Condes, 2019
Resumen: La publicación de las investigaciones científicas ha tenido gran importancia en la sociedad, ya que el principal objetivo hasta hace poco había sido la divulgación de los conocimientos, con el fin de mejorar el desarrollo de la humanidad.
Dulce María Espinoza
doaj   +1 more source

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: A protocol for a randomized trial [NCT00128076]

BMC Musculoskeletal Disorders, 2006
Background Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair ...
Razmjou Helen, Holtby Richard, MacDermid Joy C, Bryant Dianne   +3 more
doaj   +1 more source