Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study

Journal of Diabetes Science and Technology

Volumn 6, Issue 6, 2012, Pages 1296-1304

  Spencer, Kimberly ^a   Colvin, Kelly ^a   Braunecker, Brad ^a   Brackman, Marcia ^a   Ripley, Joyce ^a   Hines, Paul ^a   Skrivanek, Zachary ^a   Gaydos, Brenda ^a   Geiger, Mary Jane ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Adaptive dose finding; Dulaglutide; Seamless design

Indexed keywords

CONFERENCE PAPER; DATA ANALYSIS; DIABETES MELLITUS; DOSE CALCULATION; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; MEDICAL DOCUMENTATION; STUDY DESIGN; TREATMENT PLANNING; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; METHODOLOGY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ANTIDIABETIC AGENT; DULAGLUTIDE; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

DIABETES MELLITUS; DOUBLE-BLIND METHOD; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; RECOMBINANT FUSION PROTEINS; RESEARCH DESIGN;

EID: 84883027307     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681200600608     Document Type: Conference Paper

References (6)

1. Geiger MJ, Skrivanek Z, Gaydos B, Chien J, Berry S, Berry D, Anderson JH Jr. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics. J Diab Sci Tech. 2012;6(6):1319-27.
2. Skrivanek Z, Berry S, Berry D, Chien J, Geiger MJ, Anderson JH Jr., Gaydos B. Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations. J Diabetes Sci Technol. 2012;6(6):1305-18.
3. Efron BT, Tibshirani RJ. An introduction to the bootstrap. In: Monographs on statistics and applied probability. Vol 57. New York: Chapman & Hall; 1993.
4. Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Info J. 2006;40(4):437-44. (Pubitemid 44721121)
5. Gaydos B, Anderson KM, Berry D, Burnham N, Chuang-Stein C, Dudinak J, Fardipour P, Gallo P, Givens S, Lewis R, Maca J, Pinheiro J, Pritchett Y, Krams M. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Info J. 2009;43(5):539-56.
6. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry: adaptive design clinical trials for drugs and biologics. February 2010. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Accessed July 29, 2012.