CLINICAL

Oncology trials

Institute of cancer research Exemestane study

Randomised double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant Tamoxifen for 2-3 years, comparing treatment until 5 years with adjuvant Exemestane versus further Tamoxifen.

Particular issue in this study involved defining relative dose intensity.

National cancer research network

A phase III study of radical radiotherapy with or without Gemcitabine in patients with T1-2 N0-1 M0 non-small cell lung cancer.

ProStrakan

Transdermal Granisetron for prevention of chemotherapy induced nausea and vomiting (CINV).

A large, phase III multi-centre pivotal regulatory study. Quantics was extensively involved with the design, statistical analysis plan, blind data review, and medical monitoring up to publication of top-line results. This was a formal, non-inferiority study and involved statistical methodology discussions with the regulatory statisticians.

Quantics has been involved with many aspects of regulatory submission, including responding to regulators' queries (USA, Europe, Japan).

www.prostrakan.com

Hormonal trials

Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

This large study involved a complex analysis of previous study data in order to design a protocol dosing regimen that would meet the requirements of regulatory authorities with respect to PK profiles.

Vaccine trials

Avecia (now PharmAthene)

Work to date has included new statistical methodology development and review (including discussions with the FDA) trial design, analysis and recommendations for further trials.

Living cell Technologies

DIABECELL® is designed to help treat unstable Type 1 diabetes. Living cell technologies (LCT) currently has Phase IIb clinical trials underway in New Zealand and Quantics is responsible for data management, statistical analysis and support.