[Remission in phase II and phase III studies: criteria and prerequisites].
We identify factors of influence for the observed variability of published rates of remission and we derive from these findings prerequisites and criteria for the assessment of remission in cancer therapy. As a consequence we postulate a separate assessment of patients with measurable and with non-measurable disease and a complete documentation of those patient characteristics in order to compare rates of remission of different studies. Several methods for the determination of sample sizes in phase II and phase III clinical trials are presented and discussed.
Edler
L
L
Abteilung Biostatistik, Deutsches Krebsforschungszentrum, Heidelberg.
Flechtner
H
H
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D005500:Follow-Up Studies; D006801:Humans; D008501:Medical Records, Problem-Oriented; D009367:Neoplasm Staging; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000970:Antineoplastic Agents
Remission in Phase-II- und Phase-III-Studien: Kriterien und Voraussetzungen.