Decentralised elements in clinical trials - New service

You may have read our previous blog post on how we work with Patient Support Programs to help patients become informed and lead their treatment.

We continuously seek new or improved ways to help patients engage and lead lives more as people and less as patients. During one of these conversations, we discussed how we could leverage our competencies within PSP and Clinical Operations to drive change for patients in clinical trials. The result is our new service: home-visits in clinical trials. In a clinical trial with decentralised elements, trial related procedures, such as distributing IMP (investigational medicinal product), collecting blood samples or conducting other tests, can take place at trial participant’s home instead of having to travel to the clinical trial site.

We possess the quality assurance competence from both a GCP perspective and the expectations of a registered healthcare provider. We understand the risk management activities needed during the planning and execution. Our nurses are GCP trained and have streamlined processes. Our well-tested business continuity processes ensure contingency during times of process disruption.

Expanding access: increasing diversity in clinical trials to benefit all patients 

In Nordic countries such as Sweden and Finland, there is a noticeable decrease in clinical trials. This trend needs to be reversed to ensure patients in these regions can participate in trials and benefit from the latest innovations. At Oriola, we aim to be a key stakeholder and partner in turning this trend around. One of the ways to make our countries more attractive for clinical trials is by ensuring effective patient recruitment and retention.

Home-visits help to broaden the recruitment base, allowing patients who live far from the clinic to participate in trials. This is particularly important when there is a small patient pool to recruit from, or when patients, due to their condition, face challenges in traveling to the clinic. It also provides an opportunity for people who work to participate in trials without having to take time off from work, as trial visits can occur at their homes or workplaces.

Ensuring that more people can participate in trials is crucial from a patient perspective. Where an individual lives or what their occupation is should not prevent them from participating in clinical trials. Additionally, decentralized elements may help to recruit patients and adapt the trial to their everyday lives, resulting in a lower drop-out rate. Demonstrating a track record of efficient patient recruitment and retention are vital factors in making the Nordic countries attractive for conducting clinical trials.

Drawing on our previous experience with the Hepatitis C bus, we intend to create a mobile study site that travels closer to patients' homes. Decentralised elements, such as home-visits, have been discussed and tested in small-scale projects. It is time for us as an industry to turn thoughts into actions.

Want to learn more? We recommend the Knowledge base from the DCT working group with representatives from Uppsala Clinical Research Center, Region Stockholm and the pharmaceutical industry. They have created a document that gives great guidance on the topic

Do you want to discuss decentralised elements in clinical trials? Let’s book a meeting to continue the discussions: