Site-Centric Clinical Trials

“Patient centric” approaches to clinical trials are the talk of the industry, but I’d like to propose that the clinical trials industry should be talking more about “site centric” clinical trials.

For better and worse, decentralized and hybrid trials are having a significant impact on sites who participate. The mantra of decentralized trials is “patient centered” and removing barriers to their participation. It’s wonderful that this is now being discussed by our industry at large. However, clinical trial sites have been at the forefront of “patient centricity” for the 27 years I’ve been doing clinical research.

Clinical trial sites have been at the forefront of “patient centricity” for the 27 years I’ve been doing clinical research

25 years ago we were added as a rescue site to a clinical trial that was struggling with recruitment. The drug involved was delivered by infusion for individuals affected by psoriasis. At the time, there were very few effective treatments for people with moderate to severe psoriasis. Recruitment was very slow because the infusions and follow up monitoring meant the participant had to be at the office pretty much the whole day. Infusions were once a week for eight weeks. Potential participants couldn’t take time off work because of the intense visit schedule even though they were interested in being involved. To make matters worse, the sponsor wouldn’t supply the infusion pumps necessary, and we didn’t have any at our site.

We set to work at figuring out how to turn the current design into a patient-centric study. It was not an option to change the protocol. We had to figure out how to take the current protocol and remove as many barriers as we could through changing how we operated. Not to be deterred by the obstacles, we bought six infusion pumps on our own. We hired two infusion nurses to work weekends and ran infusion visits every Sunday for about six months. The study visits were staggered so that we started infusions every 30 minutes. Once the participant began the infusion, they were moved to a large boardroom and sat at the boardroom table with all the other participants who had visits that day. Who knew at the time that not only was this enabling the psoriasis patients to get involved with the study, but they ended up connecting with other people who were going through the same challenges they were. It turned out that our patient centric approach also morphed into a psoriasis support group. It was an incredible experience (for both us and the participants). We learned so much about conducting clinical trials and managed to enroll enough participants to finish the study quickly.

We set to work at figuring out how to turn the current design into a patient-centric study

Fast forward twenty-five years and the industry is focusing incredible time and resources on patient centric design – home visits, remote visits, technology, and more.

The fact that increased effort is being put into this is great, but what about the sites who do the work of clinical trials? Is anyone talking about site centric study design?

The approach to site centric design would look something like this. Industry would engage experienced clinical trial sites in a meaningful way and not in the way sites are typically engaged in our industry. The clinical trials industry typically engages sites to tell them how things will be done. Instead, imagine a world where sites were engaged and asked to share their ideas on how our industry could better support the sites who take care of the study participants.

Who would know better how to make clinical trials more patient centric than the sites who have been doing research for 20+ years?

Does industry realize that by making studies more site centric, they will become more patient centric as well?

by making studies more site centric, they will become more patient centric as well

That’s a bold claim. Let me give some examples of site centric approaches to clinical trials that would also benefit participants.

Sites work early mornings, late afternoons, evenings and sometimes weekends to accommodate participants’ schedules for study visits. What if study budgets provided additional funding for visits that occur outside regular business hours to enable sites to do more of this and better accommodate the patient’s schedule.

One of the biggest impediments to patient centric clinical trials are the restrictions and errors by the central labs and couriers. Labs and couriers dictate when patients can be seen because the couriers only pick up at specific times and most labs don’t accept samples on Sundays. Sponsors and CROs could engage couriers and labs that can enable a site to work efficiently and at hours that suit the participant. Next – solve the massive problem of labs that lose or misplace samples or can’t get supplies to the sites on time. The resulting number of repeat and cancelled / delayed visits mean that clinical trials are anything but patient centric.

What if our industry stopped using technology that doesn’t work properly? Visits are cancelled or delayed because a technology isn’t functioning. Visits often now take twice as long to conduct – because, while the technology gets the data to the sponsor faster, it can cut site efficiency in half. Study coordinators spend countless hours being IT support to study participants. If technology issues were addressed, visits would be shorter, participants would be happier, and the study coordinator would have more time for recruitment.

These are just a few ideas to begin a discussion. There are many other ways to make clinical trials more site centric. If studies became more site centric, they would become much easier for individuals to participate and isn’t that the goal? 

If studies became more site centric, they would become much easier for individuals to participate and isn’t that the goal?