ON THE VALUE OF LARGE MULTICENTER DRUG INTERVENTION TRIALS

Many large multicenter clinical drug trials are outcome trials with several thousand patients, therefore also called megatrials, numerous of which encompassing the cardiovascular field. Usually designed to test and compare the efficacy of a specific therapy with the major aim being improved outcome at hard endpoints, specifically morbidity and mortality, they are representative of typical intervention trials. Considering also the risk of failure, examples of large multicenter therapy trials are examined as to their value to the patients, the society, the health care providers, and - finally - also the manufacturers of the respective drugs. The 'Syst-Eur Trial' (Systolic Hypertension in Europe) representing a very recent intervention trial to treat isolated high systolic blood pressure in elderly patients with treatment based on a calcium channel blocker, nitrendipine (CAS 39562-70-4, Bayotensin® , Baypress® * ), serves to indicate that besides the major end-point results, here total stroke rate, a number of important additional efficacy and safety results may be obtained with large trials, such as in this case favourable data on total mortality, myocardial infarctions, cancer, bleeding.