Experience

Clinical trials ExperienceThe 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:

  • 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)
  • 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)
  • 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)
  • 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)
 
   

National Surveys Experience

From 1990, and bi-annually thereafter, nationwide
2- month surveys have been conducted in all Israeli CCUs (and internal medicine wards in the 2000 survey).
These surveys assess the characteristics, management and outcome of acute coronary syndrome patients with specific emphasis on use of reperfusion therapy, re-vascularization procedures and subsequent outcome.

Additional surveys include:

  • The first congestive heart failure survey – conducted
        in 2003 in all cardiac departments and more than
        90 internal medicine wards.
  • The Israeli survey of pacemaker and ICD implantation conducted in Nov 2002-Feb 2003
  • The first National Acute Stroke Israeli Survey for the Israel Neurological Association.