Study of Immune Drug Side Effects-SIDEFX. Version 1.0
Research type
Research Study
Full title
Study of immune related drug side effects underlying adverse drug reactions in gastroenterology
IRAS ID
159624
Contact name
Tariq Ahmad
Contact email
Sponsor organisation
Royal Devon and Exeter Hospital
Duration of Study in the UK
2 years, 8 months, 2 days
Research summary
All drugs have the potential to cause harm as well as benefit. An adverse drug reaction (ADR) is defined as any noxious or unintended reaction to an otherwise safe and effective drug. Fortunately most ADRs are mild but sometimes they can be severe and life threatening. ADRs account for approximately 5% of all hospital admissions in the UK and in 2008 the EU Commission estimated that these reactions kill 197,000 EU citizens annually at a cost of 79 billion Euros.
There is convincing evidence to implicate the immune system in the pathogenesis of many ADRs. Modern genetic technologies have demonstrated that some ADRs occur preferentially or even exclusively in individuals carrying specific genetic variants.
Our 5ASA and PRED studies are currently investigating the genetic factors underlying ADRs in Gastroenterology (and other diseases), and have already successfully identified genetic variants which increase the risk of a patients suffering from two serious drug reactions. We would now like to explore the immunological mechanisms underlying these reactions by comparing immune cells from patients with genetic risk factors who experienced an ADR with immune cells from other individuals who are tolerant of the same drug. A detailed knowledge of these mechanisms is highly desirable for optimal safe utilisation of drug therapies as well as facilitating the design of safer drugs in the future. This project will be completed within 3 years.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0017
Date of REC Opinion
9 Mar 2015
REC opinion
Further Information Favourable Opinion