临床试验研究设计终点和生物标志物药物安全性 890条(本栏目收费,不能显示细节,电话13136136841)
missing data examples,443–444 444
post-marketing report CIOMS I form,450–451 451
MedWatch form,448–450 450
paradoxical adverse drug reactions bronchial constriction drugs,440 440
cancer chemotherapy,437–438 438
growth factor therapy,438–439 439
supportive/palliative care in placebo arm,136 136
Van Cutsem study,230–234 234
Common Technical Document (CTD),591–594 594
Consent forms administrative law,535,538–539,541–543 543
analysis by medical community,552 552
Coyne study informed consent form,550–551 551
decision aids,556–558 558
Guidance for Industry E6,539–540,551 551
language level,543–544,553–555 555
package insert comparison,573 573
Phase I trials,555–556 556
stopping treatment versus withdrawing from study,558 558
Yellow Fever Commission,536–537 537
overall survival comparison,254–255 255