Seminar 1 – Methodology, development of guidelines & implementations of standards

Abstract:

It seems almost a paradox: guidelines and standards for treatment and individualised or personal medicine.

The EMA (European Medicines Agency) develops guidelines for drug development in clinical testing and herewith sets the standard for treatment. Institutions like NICE (the National Institute for Health and Clinical Excellence) develop clinical guidelines for treatment and patient safety. Experts in the field of a topic prepare a draft manuscript, which is published for consultation and comments. Once it is finished it is disseminated and implemented into clinical practice or used in clinical trials. Maybe more important is to measure the outcome, the change that has been made and the effort, made to proceed in this process. But how valuable are these standards or guidelines in daily clinical practice? Isn’t every patient unique in its presentation or behavior and not standardised to a standard ill being human specimen? A point of discussion might be represented by the following wording: "human thinking stops where standards start". Or is it the opposite that thinking should start where standards of care are implemented to reach our goal of personalised medicine? In this seminar speakers will highlight the pros and cons of development of guidelines and standards for care.

Teaching Goals:

• inform participants on guideline development
• inform participants on implementation of standards in pharmacotherapy
• to teach which barriers are encountered during guideline development
• to learn how standards should be used in individual therapy

Learning Objectives:

After the presentation the participant should:

• know how standards are developed and implemented
• know how guidelines are developed and implemente
• be aware that, despite the use of standards, individual therapy still needs professional attention