TY - JOUR
T1 - The effect of poor compliance and treatment side effects on sample size requirements in randomized clinical trials
AU - Schechtman, Kenneth B.
AU - Gordon, Mae O.
PY - 1994/1/1
Y1 - 1994/1/1
N2 - Treatment side effects and associated noncompliance have methodological implications vital to the testing of new drugs. In this paper, we quantify the impact of these factors on sample size requirements in clinical trials. In the Lipid Research Clinics Trial, side effects caused treatment group compliance (50.8%) to be lower than placebo compliance (67.3%). Cholesterol reduction among treatment noncompliers was 35.2% of the reduction among com-pliers. Had treatment group compliance been as high as placebo compliance, 41% fewer patients would have been required to achieve.
AB - Treatment side effects and associated noncompliance have methodological implications vital to the testing of new drugs. In this paper, we quantify the impact of these factors on sample size requirements in clinical trials. In the Lipid Research Clinics Trial, side effects caused treatment group compliance (50.8%) to be lower than placebo compliance (67.3%). Cholesterol reduction among treatment noncompliers was 35.2% of the reduction among com-pliers. Had treatment group compliance been as high as placebo compliance, 41% fewer patients would have been required to achieve.
KW - Lipid Research Clinics trial
KW - Noncompliance
KW - Randomized clinical trials
KW - Sample size requirements
KW - Treatment side effects
UR - http://www.scopus.com/inward/record.url?scp=0028131172&partnerID=8YFLogxK
U2 - 10.1080/10543409408835085
DO - 10.1080/10543409408835085
M3 - Article
C2 - 7951277
AN - SCOPUS:0028131172
SN - 1054-3406
VL - 4
SP - 223
EP - 232
JO - Journal of Biopharmaceutical Statistics
JF - Journal of Biopharmaceutical Statistics
IS - 2
ER -