title: Age-adjusted reference values could be used for screening healthy older people in clinical trials.
abstract: Healthy adults are generally recruited for first-in-human clinical trials. However, their inclusion/exclusion criteria are not easily applied to trials for the elderly. Reference values were modified by 10-20% in screening tests to investigate the usefulness of the age-adjusted inclusion/exclusion criteria. Seven items were modified, including fasting blood sugar (FBS) and systolic blood pressure (SBP). Of the 28 screening failures, modified FBS caused 11 screening failure cases with no concomitant medication. Elevated SBP affected few concomitant medication cases in the middle-aged. Age-adjusted reference values maintained the inclusion/exclusion criteria of healthy elderly Korean participants by rendering the concomitant medication issue clinically insignificant.
authors: TKM (Traditional Korean Medicine)-Based Herbal Drug Research Group, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors: Sunha
authors: S
authors: Park
authors: Dal-Seok
authors: DS
authors: Oh
authors: Ho-Ryong
authors: HR
authors: Yoo
authors: Bongjoo
authors: B
authors: Kang
mesh_terms: D000367:Age Factors; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure / Q000502:physiology; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003430:Cross-Sectional Studies; D005260:Female; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D056910:Republic of Korea; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D001786:Blood Glucose; D006454:Hemoglobins; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase