[Registries for clinical trials -- a critical stock-taking].
A German working group had requested to introduce a national clinical trials registry. Keeping in mind the numerous existing German clinical trials registries requirements of such a registry, as well as the current international harmonization initiatives and the possibility of creating such a national registry were considered. To avoid multiple recording especially in regard to multicentric, international trials, it is recommended -- based on the spirit of the WHO recommendations -- to use the trial registry of the National Institutes of Health. For the time being, this trial registry represents the by far most frequently used database available for public use. It is equipped by internationally active pharmaceutical companies as well as universities and research facilities from all over the world and actually contains approximately 23,500 clinical studies. A national clinical trials registry could be installed at best only complementary and would have to get its data directly from the international registry without additional burden by research facilities.
Bestehorn
Kurt
K
Institut für Klinische Pharmakologie, Medizinische Fakultät Carl Gustav Carus, Technische Universität, Dresden. Public.Health@mailbox.tu-dresden.de
Hönig
Reinhard
R
Clemens
Norbert
N
Kirch
Wilhelm
W
D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection / Q000592:standards; D005858:Germany; D006801:Humans; D015337:Multicenter Studies as Topic; D009316:National Institutes of Health (U.S.); D012015:Reference Standards; D012042:Registries / Q000592:standards*; D014481:United States; D014944:World Health Organization