FUTURE Initiative

  • Research type

    Research Study

  • Full title

    A proposal to create a database of volunteers who have been fully genotyped for drug disposition genes for early phase studies

  • IRAS ID

    199102

  • Contact name

    Munir Pirmohamed

  • Contact email

    munirp@liv.ac.uk

  • Sponsor organisation

    University of Liverpool

  • Clinicaltrials.gov Identifier

    WK49-01/GP/DLN, University of Liverpool Funder Reference; UoL001202, JRO Sponsorship Reference

  • Duration of Study in the UK

    4 years, 11 months, 28 days

  • Research summary

    Stratified medicine (also known as personalised or precision medicine) is a modern approach that uses the latest technologies, including genomic tools, to segment or stratify cohorts of participants by subclass of disease or the likelihood of responding to a particular therapy allowing the bespoke classes of medicines to be developed and used rather than the one-size-fits-all blockbuster drugs. Liverpool is recognised as an important player in this rapidly advancing discipline and has a portfolio of research studies which are spanning the whole spectrum from discovery to implementation, with the ultimate aim of improving the benefit-risk ratio of existing and future medicines.

    Rapid advances in technology mean there is a clear path to a new world of medicine where underlying genetic information guides treatment. With the potential for significant economic and patient benefit, there is global interest to demonstrate and roll-out stratified medicine. Currently there is no site in the UK regularly offering healthy volunteer studies that are stratified according to their genotype for phase I/II studies. The FUTURE initiative is an opportunity to bridge this translational gap between academic research and clinical trials and will bring the science of stratified medicine to future drug development (as well as existing drugs) by allowing us to move from the one-dose-fits-all model to more precision dosing. Our study will offer academics and industry a ‘one-stop-shop’ for the recruitment of genotyped healthy volunteers to further studies that assist in improving drug efficacy and safety.

    FUTURE will provide access to a stratified cohort of healthy volunteers for clinical trials who have been genotyped for drug metabolising enzyme and transporter genes that can be readily recruited for phase I healthy volunteer studies. Part 1 of FUTURE will focus on recruiting a prospective cohort of 3000 healthy volunteers. Part 2 of FUTURE will provide a business model whereby FUTURE will offer access to a panel of genotyped healthy volunteers for potential recruitment to phase I trials. The study population will be recruited through the Royal Liverpool & Broadgreen University Teaching Hospitals NHS Trust (RLBUHT). If necessary recruitment will open up to other research centres to assist reaching the recruitment target for the study.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    16/NW/0097

  • Date of REC Opinion

    16 Mar 2016

  • REC opinion

    Further Information Favourable Opinion