Your decentralized trial design cannot be "one-size fits all" - MRN

Your decentralized trial design cannot be “one-size fits all”

How can we truly decentralize and support patients, sites and sponsors?’

The industry has experienced a lot of change over the last 3 years, one that was surprising to me is that from the time the pandemic started over 3,000 one-time, single trial sites have left the research field and that statement really stuck with me.  I wonder how that has impacted drug development how many eligible patients are now without access to a trial, especially if those sites are smaller institutions that are trusted and respected in their communities.

And the punches just kept coming, the next statement from that same panel was that recruitment and retention are worse and innovative approaches take on average of 6 years to adopt within one area of a business and for an entire enterprise to adopt, 20 years!

With the slow rate of adoption and the painful realization that the environment we are trying to conduct clinical trials in is narrowing, it was a stark awakening for those of us who so deeply want to progress the industry – are we really helping? It became clear that there are still many problems without solutions.

“Patients are connected to PIs and we must never forget that”

One panelist stated, The idea that everything is decentralized hasn’t panned out and it’s probably not the way to do it. I think that’s a fair statement if you take an all or nothing approach.  But the design of a trial isn’t one size fits all. Patients need the ability to participate in a trial without always having to travel to a site but also, they need to have that face-to-face, relationship building elements of care. Sites, PIs and healthcare professionals are important. Everyone wants to feel understood, listened to and cared for and this is even more paramount when taking the leap to participate in a clinical trial. With the pandemic, we lost a lot of that ability to build relationships with patients and I’m sure we all felt this in some way in our own lives.  We need to get back to building relationships with patients whether they are at the site or not.

“Technology won’t save clinical trials”

Finding the “right” way to do this might not exist but there are steps post-pandemic that we can take to get to a better outcome for sites and patients.  Sites struggled financially with the pandemic when they rely on income from research. Some pharma companies have encouraged sites to think about how to do things differently. Digital tools to support DCTs were exciting, but it can’t be ‘tech solutions only as a solution to a problem’, we must meet patients, sites and sponsors where they are today to have the most meaningful impact. Some pharma companies are conducting user feedback studies about the utilization of mobile tech for patients and sites and looking at how they can support patient-led and patient preference trial design, this is a great initiative.

The traditional methods aren’t working and as one panelist so eloquently said ‘pressure is a privilege’ so how do we disrupt and innovate to ensure we create clinical trials that are inclusive, transparent, human centered and supportive of our healthcare institutions and the very real pressures they face?

To make an impact, it’s now time for program level adoption, not more pilots.

Back to the newsroom