Laboratory screening method for selection of healthy volunteers
Tóm tắt
The aim of laboratory screening in Phase I is to exclude subjects with subclinical illness, who might be at increased risk in the study, and who might also adversely influence interpretation of the results. A new method for laboratory screening, based on Bayesian probability theory, is proposed, which consists of:
Use of this deductive method in screening volunteers for Phase I trials affords increased security of selection, while reducing the number of non-pertinent exclusions because of laboratory findings.
Từ khóa
Tài liệu tham khảo
Grasbeck R, Siest G, Wilding GZ, Whitehead TP (1978) IFCC Committee on Standards. Expert panel on the theory of reference values. Clin Chem Acta 87: 461–469
Joubert P, Rivera-Calimlim L, Lasagna L (1975) The normal volunteer in clinical investigation: How rigid should selection criteria be? Clin Pharmacol Ther 17: 253–257
Joubert P, Pannall P (1976) The selection of healthy volonteers for clinical investigation: the case for volunteer pools. Cur Med Res Opin 4: 192–196
Schoen I, Broown SH (1970) Judgment based on 95% confidence limits: A statistical dilemma involving multitest screening and proficiency testing of multiple specimens. Am J Clin Pathol 53: 190–193
Schrogie JJ, Hensley MJ, Diogore CH, Harris S (1977) Evaluation of the prison inmate as a subject in drug assessment. Clin Pharmacol Ther 21: 1–7
Thompson LW, Brunelle RL, Enas GG, Simpson PJ (1987) Routine Laboratory Tests in Clinical Trials: Interpretation of Results. J Clin Res Drug Develop 119: 1–95
Weinstein MC, Fineberg HV (1980) Clinical decision analysis. Saunders, Philadelphia, pp 75
Woodward W (1979) Informed consent of volunteers: a direct measurement of comprehension and retention of information. Clin Res 27: 248–249