The Changing Landscape of Decentralized Clinical Trials

FESCH.TV INFORMIERT:

Traditional clinical trials models were solely focussed on the site.  Sites were selected for participation based on their experience, expertise and supposed recruiting ability; this process was often hurried and reliant on their track record and database.  The problem is that not all trials are the same; whilst a site may deliver well in one design, they may fail in another.  Why?  Because at the end of the day, it’s the patient who has to sign the consent and if they don’t want to participate, if the trial is too burdensome, then the site will fail to deliver, and the trial will be delayed.

As the world evolves, especially in today’s pandemic, patients demand more and indeed expect more as technology improves; when considering participation in a trial, visiting the site on a regular basis isn’t always attractive or possible.  Why can’t the trial come to the patient?  Why can’t the patient interact with site staff online?  Of course, they can.

Patient centric trials, virtual trials, community-based models, decentralized trials … whatever you call them, focus on taking the patient care in clinical trials to the patient.  If the trial goes to the patient, they are more likely to participate and importantly continue & complete.  The patient’s location becomes less of a problem, they don’t need to travel to site as often, so sites can recruit from further afield, increasing their contribution, whilst not over burdening their own staff.

Patients are allowed more choice of treatments they may otherwise not be offered, or not be able to commit to; this is especially important in pediatric & rare indications where the logistics of participation are further increased.

In a world of social media & Amazon, the traditional model will longer cut it; the decentralized world is here and there is no going back.