Recent pharmaceuticals trial involvement
Oncology trials
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. Following the study completion, Quantics has been involved with many aspects of regulatory submission, including responding to regulators' queries (USA, Europe, Japan). This was a formal non-inferiority study and involved statistical methodology discussions with the regulatory statisticians.
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.
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.
The results of the second interim analysis of efficacy were published in the New England Journal of Medicine in March 2004 on the recommendation of the Independent Data Monitoring Committee. This early release of results was prompted by a highly significant early disease-free survival benefit, which exceeded the predefined statistical stopping boundary.
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.
Analgesic trials
Nitroglycerin ointment
Quantics has been key in the statistical due diligence work, and subsequent trial design for this product. Particular issues for consideration were the use of active placebo to help ensure blinding during the trial, and 'last observation carried forward' (LOCF) techniques.
Vaccine trials
Pre clinical and clinical vaccine trials. Avecia (now PharmAthene)
Work to date has included new statistical methodology development and review, trial design, analysis and recommendations for further trials.
See also: Investigator-led clinical trials
