Evaluation of medicines for people with prostate cancer
Research type
Research Study
Full title
Real World Evidence, Clinical Decision Support and Evaluation of Medicines for Prostate Cancer
IRAS ID
276757
Contact name
Roma Maguire
Contact email
Sponsor organisation
University of Strathclyde
Duration of Study in the UK
0 years, 6 months, 11 days
Research summary
With health and social care systems under increasing demand, there is a need to look at new ways of delivering high quality, value based care in the use of medicines. There has been an increasing focus on identifying ways to determine what treatments are best for patients, their effectiveness in the real world versus clinical trials, and how they compare to other treatment options. The use of Real-World Evidence (RWE) aims to answer some of these questions. RWE has been defined as: “Healthcare information derived from multiple sources outside of typical clinical research settings, including electronic medical records (EMR), claims and billing data, product and disease registries and data gathered by personal devices and health applications”.
Using RWE could provide insights into the safety and effectiveness of medicines beyond clinical trials. This information can inform approaches to new medicines’ approval and continuing use of established ones – ensuring good value for money, and most importantly, patient benefit. Data from mobile health applications and wearable technologies can allow meaningful and regular data collection, providing continuous insight into the impact of medicines.
Considering the impact side effects can have on people with prostate cancer and their families, it is imperative they are closely monitored and that side effects are managed. The aim of this study is to define ways in which two medicines for prostate cancer (Abiraterone and Enzalutamide) can inform the development of a specification for a real-world value system by which prostate cancer medicines can be assessed and evaluated using digital solutions in real-time. The study will involve interviews / focus groups with key stakeholders involved in the assessment, management and evaluation of medicines for people with prostate cancer across Scotland. Participants will include people with prostate cancer and their partners; health and social care professionals; and others.
REC name
London - Queen Square Research Ethics Committee
REC reference
20/PR/0551
Date of REC Opinion
26 Oct 2020
REC opinion
Favourable Opinion