FUTURE 2 - Patient Cohorts
Research type
Research Study
Full title
A proposal to create a database of patient cohorts who have been fully genotyped for drug disposition genes for early phase studies.
IRAS ID
262694
Contact name
Munir Pirmohamed
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Summary of Results:
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. In 2016, The University of Liverpool identified that there were no sites in the United Kingdom (UK) regularly offering volunteer studies that are stratified according to their genotype for phase I/II studies. The FUTURE initiative was designed as an opportunity to bridge this translational gap between academic research and clinical trials and to 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. The aim of the study was to 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 2 is the next step to complement the healthy volunteer cohort and further develop, expand and drive the business model. The recruitment of patient cohorts with conditions of interest to obtain genetic and other biological samples for pharmacokinetic studies is necessary. This is an important step, which will enhance resources available for business purposes.
It is extremely important that we involve patient cohorts, as Regulatory Authorities require that pharmacokinetic studies are carried out on drugs in clinical development in patients with renal or hepatic impairment if the drug, or a principal active metabolite, is substantially eliminated by either route and when the drug is likely to be used in such patients. The principal objective of renal or hepatic impairment studies is to develop dosing recommendations so that patients and practitioners can alter dose and dosing intervals appropriately.Lay Summary:
Studies were paused during the COVID pandemic by the NHS Trust. Given that we were dealing with a clinically vulnerable (to COVID infection) population, this was appropriate. When the studies were due to re-start, the funding allocated to this had already been used during the pandemic and no new funding was available. We, therefore, had not choice but to close the study.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0329
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion