This proposal is for the Medical Statistics Section (MSS) at the University of Alabama at Birmingham to serve as the Data Coordinating Center (DCC) for the study of alternative therapies in benign prostate symptoms. It is anticipated that 10 Clinical Evaluation and Treatment Centers (CETCs) will enroll approximately 3100 men with benign prostatic hyperplasia (BPH) in a randomized, double-masked, placebo-controlled study of two phytotherapy agents, Serenoa repens (Saw palmetto) and Pygeum africanum in the treatment of BPH.
Specific aims of the DCC are to: provide statistical expertise in study design and analyses; provide data management support for the study; develop and maintain a WEB-based system for data transmission and communication from the CETCs to the DCC; establish a Phytotherapy Distribution Center to distribute Saw palmetto, Pygeum africanum and placebo to the CETCs; and provide administrative support for meetings of the Steering and Planning Committee, Executive Committee, Data Safety and Monitoring Board and any subcommittees formed during the progress of the trial. The strengths of the MSS in serving as the DCC are: its well-established infrastructure (personnel, computing facilities, communications networks, and data management system) for providing support to clinical trials; its experience in serving as the coordinating center for NIH-supported multicenter clinical trials groups; and its participation in the UAB Chemoprevention Center.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK063788-02
Application #
6668571
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2002-09-30
Project End
2009-03-31
Budget Start
2003-04-01
Budget End
2004-03-31
Support Year
2
Fiscal Year
2003
Total Cost
$780,936
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Lee, Jeannette Y; Moore, Page; Kusek, John et al. (2014) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. J Altern Complement Med 20:48-52
Barry, Michael J; Cantor, Alan; Roehrborn, Claus G et al. (2013) Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J Urol 189:987-92
Andriole, Gerald L; McCullum-Hill, Christie; Sandhu, Gurdarshan S et al. (2013) The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. J Urol 189:486-92
Helfand, Brian T; Lee, Jeanette Y; Sharp, Victoria et al. (2012) Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol 188:2288-93
Barry, Michael J; Avins, Andrew L; Meleth, Sreelatha et al. (2011) Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology 78:550-4
Barry, Michael J; Meleth, Sreelatha; Lee, Jeannette Y et al. (2011) Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 306:1344-51
Helfand, Brian T; McVary, Kevin T; Meleth, Sreelatha et al. (2011) The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol 185:2223-8
Lee, Jeannette Y; Foster Jr, Harris E; McVary, Kevin T et al. (2011) Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med 17:469-72
Lee, Jeannette; Andriole, Gerald; Avins, Andrew et al. (2009) Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials 6:628-36