UK Research & Innovation (UKRI), via Innovate UK, has granted £1.1m ($1.4m) to researchers and industry partners to investigate patients’ experiences of cell and gene therapies in clinical trials.
The PROmics study is a joint venture between the Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC), the University of Birmingham’s Centre for Patient Reported Outcomes Research (CPROR), and Dignio, a Norwegian remote health-monitoring firm.
Dignio is responsible for developing the technology, and UK-headquartered Datatrial will integrate the electronic patient reported outcomes (ePRO) data with clinical outcome manufacturing data.
According to a Birmingham Health Partners spokesperson, patients will report their symptoms and quality of life via a tablet – both at the point of receiving therapy and on a longer-term basis.
“[The patients] will be involved in the design of the reporting software/app to ensure it is fit-for-purpose, meets their needs, and is easy to use,” the spokesperson added.
Participants will be selected from various disease populations to inform the most appropriate treatments, we were told.
“At this stage, there are several trials in the process of being worked up, and each will involve different types of cells,” the spokesperson continued. The first trials being set up and run by the Cancer Research Clinical Trials unit and MW-ATTC will be early phase – Phase I or Phase II, she added.
According to CPROR’s Melanie Calvert, the data generated will then be used to “assess the effectiveness of treatments, support patient care and provide a crucial evidence base for regulators and policy makers.”
“Ultimately, the PROmics study will help establish he safe and efficient delivery of Advanced Therapy Medicinal Products (ATMPs) to patients and also maintain the UK’s leading role globally for developing new therapies,” she added.
The PROmics study is due to begin this month.