Bruce Hellman
CEO and Co-founder, uMotif
Patients are playing a central role in the changing approach to clinical trials.
Closer involvement of patients in clinical trials is showing significant benefits in improving research.
Technology that positively supports patients and sites can make the experience more enjoyable, leading to better data.
Bruce Hellman, who runs uMotif – a patient-centric data capture platform for decentralised clinical, real-world, and post-marketing research – says: “Patients say they really enjoy taking part. There is the dual benefit it gives a patient, both in understanding their condition better and being a more active participant in healthcare journey. They love knowing their data is making a difference.”
Patient-centric
The company works in clinical and real-world studies, with patient-centric technology to make it easier for patients and sites to capture vital research data.
Patients have been at the core of designing the technology, which captures a range of symptoms, assessments, outcomes measures and eDiaries (eCOA / ePRO), often alongside wearables and devices that reduce the burden on users and ensure high levels of engagement. Over half of drugs coming to market use such patient reported data in their regulatory filings. This data can also help pharma companies explore new indications for existing drugs, meaning the patient role is vital.
Patients say they really enjoy taking part. There is the dual benefit it gives a patient, both in understanding their condition better and being a more active participant in healthcare journey.
Having worked closely with thousands of patients with conditions from Parkinson’s Disease to Glioblastoma, he says: “By engaging patients and making them feel an integral part of the study, we find they capture lots of data, are compliant with what needs to be captured and stick with the study thereby reducing drop out.”
In one study, so much data was captured that it ran six months quicker than planned. Highly engaged participants captured more data than expected, and combined with fewer dropouts the study team achieved their data volume earlier.
Captured data is uploaded to the cloud for researchers to analyse with Mr Hellman suggesting uMotif’s technology is enabling them to do their job more effectively and more efficiently.
Decentralised trials
The uMotif platform has benefits for trial sponsors in quicker and cheaper research and getting drugs to market faster. However, by allowing patients to participate in different locations – so-called decentralisation of clinical trials (DCT) – it is also facilitating inclusion of more diverse patient populations and including those who cannot attend large medical centres to participate.
COVID-19 has sped up a change in approach to clinical trials that was already happening – the move from site-centric approaches to patient-centric. Mr Hellman emphasises: “The key going forward is to have a very human-centric approach and to think about how technology can help the inevitable shift to decentralised trials and further engaging patients.”