The role of psychological factors in side effect reporting
Research type
Research Study
Full title
The role of psychological factors in side effect reporting
IRAS ID
134853
Contact name
Robert Horne
Contact email
Sponsor organisation
University College London Hospital
Research summary
This is a prospective observational questionnaire study with a sample of healthy volunteers and patient volunteers recruited from the Quintiles Drug Research Unit based at Guy’s Hospital.
The participants will be subjects who have been screened for participation in single blind or double blind studies at Quintiles and deemed eligible for admission into the clincal unit.
On the day of admission to the unit prior to receiving any treatment intervention, the participants will complete a series of rating scales about psychological variables, specifically their beliefs about medicines and their expectations about participating in the Quintiles trial.
Adverse events will be recorded as standard practice in the main trials.
The measured psychological variables, health screening information, trial design variables (e.g. placebo to drug allocation ratio, healthy volunteer versus patient trial) and demographic variables will be used to statistically model the reporting of non-specific side effects. In order to unambiguously identify non-specific (i.e. not pharmacologically induced) side effects, only side effect data from participants who receive placebo will be used. For participants who receive the active treatment, beliefs about medicine, health screening information, trial feature variables and demographic variables will be used to predict side effect expectations.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0244
Date of REC Opinion
25 Jul 2013
REC opinion
Favourable Opinion