Provide assistance and technical input into trial specific laboratory testing manuals to help effective transition into active trial program.
Create comparable SOPs integrated into local quality system ensuring testing compliance.
Offer a HSL-AD lead scientist assigned to each study to liaise and organise prompt result returns and assist with any queries for the duration of the trial.
Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis. OPTIMA, led by principal investigator Professor Rob Stein, a consultant oncologist at University College London Hospitals NHS Foundation Trust is a partially-blind randomised trial designed to compare clinical and economic outcomes of standard chemotherapy treatment with biomarker-directed allocation to chemotherapy or no chemotherapy in women with ER positive, HER2 negative breast cancer and either axillary node involvement or larger tumours. Participants in the trial will be assessed using a genomic test called Prosigna (also known as PAM50), which analyses the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment. The OPTIMA trial aims to show that patients with a low tumour Prosigna score can be safely treated without chemotherapy.
