Phase 1, 2 and 3 and post marketing clinical trials

May 15, 2012 Organization Services

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Clinical trials Experience

The Center has vast experience in planning, conduction and problem solving in different phases of controlled clinical trials from phase 1 & 2 studies of new compounds and medical devices performed by start-up companies to large- scale clinical trials.
The existence of the collaborative framework in Israel has, over the last decade, facilitated nationwide surveys.

Among the wide range of trials performed for pharmaceutical companies are:

  1. The SPRINT Study (Secondary Prevention Re-infarction Israeli Nifedipine Trial) – the first large-scale clinical trial organized by ISPHA, conducted in 1981-1983 and SPRINT II 1985-1986 (Bayer)
  2. BIP (Bezafibrate Infarction Prevention) Study synchronized 18 cardiac institutions, and included 3122 CHD patients.
    By virtue of its size, multiplicity of centers and its length, (1990 through 1998), the study was a major challenge, including activities from compilation of the protocol through detailed statistical analysis to publication (Boehringer-Mannheim)
  3. ARGAMI-2- a study of Argatroban in myocardial infarction – commenced in 1996 and conducted in all of the 25 CCUs in Israel.
    A detailed database, including anamnestic data, findings from physical examinations and laboratory data was established for the entire population of 5,000 patients with acute myocardial infarction who were screened. (Synth?labo)
  4. PRINCESS (PRevention of re-Infarction by early treatment of CErivaStatin Study) was a multinational randomized trial designed to determine whether early acute treatment with cerivastatin after a myocardial infarction would reduce the incidence of cardiovascular morbidity and mortality.
    ~3600 patients recruited from 14 countries were included in the study.
    Data collected in 333 centers were transferred to the Coordinating Center, which was responsible for all data management activities, and tracking and management of critical and serious adverse events. (Bayer)