Putting Patients at the Heart of the Study

By Bill Hogan, CEO, Activinsights.

What do patients think about the clinical trials in which they participate? As the industry continues to focus on capturing data and recruitment, we often forget that a patient’s experience is fundamental to the study performance.

We already know that 50% of all sites end up missing their recruitment obligations. We know too that 80% of trials are delayed often due to recruitment related issues. Sadly, we also know that 50% of all trial participants drop out before the study has completed. These numbers make for expensive and challenging outcomes.

The COVID pandemic has seen a huge increase in decentralised or hybrid clinical trials and all the indicators suggest this approach to clinical trials is here to stay. A virtual clinical trial approach requires in-depth clinical operations coupled with therapeutic expertise that is driven by technology-enabled collaboration across telemedicine, home healthcare and mobile health devices.

Connectivity is a key driver here and this is coupled with a recognition that the patient must be integrated into the design and operation of clinical trials. Such an approach has many and varied outcomes. For a start, implementing decentralised trials ensures that we democratise the opportunity for patients. Likewise, reducing the patient burden allows the conversation to move beyond ‘why’ decentralise to ‘how’ do we decentralise.

 

 

Digital Measures in Trials

Clearly, we need alignment on digital clinical measures in trials. This requires significant pre-competitive collaboration as evidenced by the great work already delivered by the DiME Society. However, the contrast in terms of collaboration in drug discovery and development as opposed to the collaboration that takes place in the aerospace industry around standards and safety is rather marked and still very far apart.

Digital clinical measures allow us to capture more novel insights whilst improving our patient centricity. Alignment on what constitutes meaningful measurement will allow us to provide validated end points that the regulators will accept. Prior to COVID, policy always dictated practice from a regulatory perspective. What we now see during the pandemic is that practice has been informing policy.

The technology has been proven to work and the outcomes are standing up to scrutiny. A digital transformation of the clinical trials space is now about “hearts and minds” as the speed of change has been breath-taking. All that remains is for us to understand how we empower organisations to make good decisions at the point of greatest impact… the patient!

Increasingly we deploy our technologies directly to patients to reduce their burden and ensure they are front and centre in the trial design. Our goal is to create a seamless experience for the patient.

Our Approach

On a global basis, fewer that 8% of all patients participate in trials. Equally, fewer that 5% of the world’s physicians participate in trials. We believe that the digital approach is an inclusive way of working and it becomes our collective responsibility to embrace it. Collaboration in this space will ultimately drive diversity, equity and inclusivity for patients.

At Activinsights we are focussed on reducing patient burden, increasing compliance and ensuring digital health measurement remains our “raison d’etre”. That is why we deliver raw data, have privacy-by-design infrastructure and why we have developed and validated our business for health research with minimal patient burden. Innovation remains at the heart of all that we do.