PROACT: Patient Reported Opinions About Clinical Tolerability.
Research type
Research Study
Full title
PROACT: Patient Reported Opinions About Clinical Tolerability. Empowering patients participating in early clinical studies and providing a way for them to directly contribute to drug development on their own terms.
IRAS ID
208496
Contact name
Jenny Royle
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
The aim of a Phase I oncology study is to recommend a dose for further investigation. To optimize this, researchers need to be able to understand drug-effects both clinically and on the experiences of patients involved. Furthermore, patients should have the opportunity to become partners in their research. For this to happen in practice, new ways of sharing information need to evolve. PROACT (Patient Reported Opinions About Clinical Tolerability) is a communication system designed to empower patients by giving them a way to directly contribute to drug-development that’s on their own terms.
A previous feasibility study concluded that PROACT can engage and empower patients, and has the potential to change the communication-paradigm for an ongoing clinical trial. However, the pilot was small and further validation is required. This is the rationale behind this larger qualitative study, which is being funded by the University of Manchester, and will be offered to patients participating on early clinical trials at The Christie Hospital. The primary aim is to further characterise the uptake and use of PROACT. In addition, we will explore involving carers in research; see whether anonymised patient-experience information has the potential to help future patients when they’re deciding whether they want to join a trial; and also assess whether such patient-experiences may be useful for future research into outcome and experience measures.
When taking part participants can use PROACT communication methods to share experiences with their medical team, have their opinions understood by study researchers, and hear general information about their trial and research that’s relevant for them, in a secure and compliant way. There are no standard questions, no standard schedule (it’s the participants choice how much they want to get involved), and at all times the participant has control over their own shared messages.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
17/NW/0539
Date of REC Opinion
30 Aug 2017
REC opinion
Favourable Opinion