HSL Advanced Diagnostics clinical trials service

HSL-AD’s highly experienced team of scientists support a wide range of clinical trials. 

Our team:

• Provide assistance and technical input into trial specific laboratory testing manuals to help effective transition into active trial programmes.
• Create comparable SOPs integrated into the local quality system, ensuring testing compliance.
• Offer an HSL-AD lead scientist assigned to each study to liaise and organise prompt result returns, and to assist with any queries for the duration of the trial.

HSL-AD also works closely with TDL Trials. They offer highly specialised and regulatory compliant pathology services for single and multicentre Phase I, II and III clinical trials, Safety and Pharmacodynamic testing, and patient monitoring services to the Pharmaceutical, Biotechnology and Research Organisations.

Case study: The OPTIMA breast cancer trial 

HSL-AD is working with the OPTIMA clinical trial – the Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis. The trial is led by principal investigator Professor Rob Stein, a consultant oncologist at University College London Hospitals NHS Foundation Trust.

OPTIMA is a partially-blind randomised trial designed to compare the 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.