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FACTS AND MYTHS CONCERNING CLINICAL TRIALS OF ONCOLOGICAL DRUGS

Piotr T. Siedlecki 

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie (COI), W.K.Roentgena 5, Warszawa 02-781, Poland

Abstract

First I will deal with the genesis of the title of my presentation. Then I will describe the criteria of the response used in subsequent phases of clinical trials and their usefulness for creation of clinical standards and daily practice. The role of EBM (evidence base medicine) and its variety - eloquence and eminence based medicine - will be described.

Personal opinion about sources of credible data (Cochran Library, NICE, PDQ) will be presented. Critical evaluation of the levels of evidence of the data and usefulness of a meta analysis and historical control (Will Rogers phenomenon) will be discussed. Then, using epoetines as an example, I will present the relationship between the pharmaceutical industry, medical journals and official institutions such as FDA and EMEA .

 

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Presentation: Invited Oral at V Multidyscyplinarna Konferencja Nauki o Leku, by Piotr T. Siedlecki
See On-line Journal of V Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2006-04-05 08:40
Revised:   2009-06-07 00:44