Surrogacy is achieved when a biomarker is used to actually predict—in fact used in place of—a clinical end point and, operationally, can be used to demonstrate pharmaceutical utility for registration of a new drug.28 Examples of biomarkers that have achieved surrogate status include blood ...
Study record managers: refer to the Data Element Definitions. If submitting registration or results information. Skip to Main Content. We updated the design of this site on December 18, 2017. Learn more. See Studies by Topic. See Studies on Map. How to Use Search Results. How to Find Resu...
Study record managers: refer to the Data Element Definitions. If submitting registration or results information. Skip to Main Content. We updated the design of this site on December 18, 2017. Learn more. See Studies by Topic. See Studies on Map. How to Use Search Results. How to Find Resu...
This debate has been rekindled with developments in mentorship and establishment of a clinical role designed to facilitate and support mentors; the Practice Education Facilitator. Hence it is timely to re-examine the role of the lecturer in providing clinical support to students. This article ...
The main changes to the previous edition are as follows: — inclusion of a summary section of GCP principles (see Clause 4); — reference to registration of the clinical investigation in a publicly accessible database (see 5.4); — inclusion of clinical quality management (see 9.1); — ...
1.7.if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; 1.8.identification of the Member States and third countries in which the clinical investigati...
It was registered with the China Clinical Trial Registry, a primary registry of the World Health Organization’s International Clinical Trials Registry Platform (Registration Number ChiCTR2300068852).Introduction Knee replacement surgery began to be widely applied in clinical practice during the 1970s and...
Update on trial registration 11 years after the ICMJE policy was established. NEJM. 2017;376(4):383–91. https://doi.org/10.1056/NEJMsr1601330. Article PubMed Google Scholar Fundação para a ciência e Tecnologia, Concurso de Projectos de I&D em Investigação Clínica. https://www...
The database is static: records do not need to be updated after registration. c. The database is not comprehensive: it includes only recruiting clinical trials. d. The database is not comprehensive: it includes only drug and device clinical trials. View chapterExplore book Pediatric Clinical Tr...
Clinical trial registration: looking back and moving ahead. JAMA. 2007;298(1):93-9417548375ArticlePubMedGoogle ScholarCrossref 22. Database for Aggregate Analysis of ClinicalTrials.gov, AACT. Durham, NC: Clinical Trials Transformation Initiative; 2011. http://tinyurl.com/9wtxmnk. Accessed March...