PREPARE
Research type
Research Study
Full title
PREemptive Pharmacogenomic testing for Preventing Adverse drug REactions
IRAS ID
219162
Contact name
Munir Pirmohamed
Contact email
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Most diseases or illnesses require treatment with medication, which can either cure the disease or control the symptoms. Medications can sometimes have side effects, some of which can be serious. We all vary in how we respond to medication base on genetics, which can result in differences in how well it works. There is recent evidence, in the form of multiple randomized controlled trials which has strongly indicated that pharmocogenetic (PGx) testing prior to prescribing a new medication can improve patient outcomes, by guiding the drug and dose selection.\n\nThe purpose of the study is to find out if personalizing medication using an individual genetic information, will lower the chance of side effects and improve efficacy and safety of medications. To investigate this we will be comparing the standard way medications are prescribed with a method that takes into account an individual’s genetic information.\n\nA total of 8100 patients from across 7 different countries across Europe will be recruited, 1500 of which will be from the UK.The study will encompass an 18 month study period and an 18 month standard of care period, with 750 patients from the Royal Liverpool University Hospital recruited in each arm. The study will last for a total of 3 years.\n\nAll eligable participants will have a blood or saliva sample at baseline for DNA analysis. They will then be followed up at 4 weeks, 12 weeks, and 18 months, to identify any potential adverse drug reactions. Participants will also be asked to fill in an online survey at 2 and 8 weeks.\n\nFor participants taking one of six commonly prescribed medications will be invited to take part in an additional sub-study to investigate in more detail any drug-drug-gene interactions. This will involve the collection of an additional blood sample at baseline, 4 week and 12 weeks.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0858
Date of REC Opinion
21 Dec 2016
REC opinion
Further Information Favourable Opinion