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CEMDC, Semmelweis University

Module 4: Clinical Trials

Practical Information

Commencing Date:
tba
Language:
English
Location:
Budapest Hungary


Teaching Methodology:
Blended Learning
Credits :
Short courses (CPD): 15 ECTS


European Fees:
1000 EUR
Scholarship Possibilities:
Yes

Course Contact

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence

Description

Module Leaders: Anthony Fox, UK and Katalin Mazalin, Hungary - under discussion The science. methodology and ethics of large, multicenter clinical trials will be reviewed. Specific attention will be given to clinical trials in specific populations: pediatric, elderly subjects as well as patients suffering from rare diseases. Study types, statistical aspects, side effect reporting, the definition of target product profile will be discussed.

Outcomes

Various types of clinical studies and the methods used to choose the appropriate design Main statistical methods used in clinical research Key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution Collection, evaluation and reporting of adverse event data in clinical trials Various quality management issues in clinical trials Impact of emerging results on the drug development plan Key operational and strategic issues in the clinical development plan Evaluation of the outcome of drug development: final therapeutic profile / usage of a medicine. Evidence Based Medicine Role of the Target Product Profile (TPP) and Target Product Claims (TPC) Role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees Statistical issues in statistical report writing Evaluation and interpretation of clinical trial results Principles and practical application of critical appraisal

Covered Areas

Scientific Areas

PK/PD modelling

Therapeutic Areas

Ageing

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered