Predicting the accrual rate in a vaccine clinical trial: an a posteriori evaluation of the feasibility study.
To estimate the expected accrual rate in a double blinded controlled randomized trial of the absolute clinical efficacy of three anti-pertussis vaccines in infants, we performed a series of surveys among mothers and physicians in the areas to be considered for participation in the trial. In this paper, we compared the predicted enrollment with the actual enrollment achieved at the end of the recruitment phase of the trial. The predicted enrollment rate was 27%, while the observed rate was 26%. Results from the feasibility study were highly predictive of actual enrollment rate. In the local health units (USL) where such assessments were carried out, the accrual rate, was higher than those not participating in the feasibility phase.
Tozzi
A E
AE
Istituto Superiore di Sanità, Laboratorio di Epidemiologia e Biostatistica, Roma, Italie.
Cofi Degli Atti
M L
ML
Panei
P
P
Anemona
A
A
Binkin
N
N
Salmaso
S
S
Luzi
S
S
Greco
D
D
D000328:Adult; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D008297:Male; D009035:Mothers / Q000193:education / Q000523:psychology; D015337:Multicenter Studies as Topic; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D010567:Pertussis Vaccine / Q000592:standards; D010820:Physicians / Q000523:psychology; D011237:Predictive Value of Tests; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results
D010567:Pertussis Vaccine