Case of dose regimen optimization for paclitaxel

A US-based biotech company, partnered with Excelra to identify whether optimal paclitaxel dosing regimen for cancer is ‘QW’ (once per week dosing) or 'Q3W' (once every 3 weeks).

Client’s requirement

Excelra helped the biotech company, which was aiming to quantify a relationship between different paclitaxel doses and regimens on safety and efficacy using summary-level data across published clinical trial literature by model based meta-analysis (MBMA).

The aim was to identify and build a database on safety and efficacy data for paclitaxel monotherapy dosing regimens in clinical practice.

Our approach

Leveraging Excelra’s PICOS methodology, scientific literature was scoped and reviewed paving the way to develop a Clinical Trials Outcome Data curated from a number of publications across trial phases with paclitaxel monotherapy in multiple oncology indications.

The clinical outcome database of these publications was developed by sheer scientific approach to capture clinical outcomes summary data (Time Vs Response in terms of safety and efficacy endpoints) with all other scoped information for each data point, about patient Population (indication),
Interventions (dose regimen), Comparator (dosage regimen), Outcomes, Study design (sample size) details.