The 3 KPIs to follow for clinical trial site success
By Anaita Tejpal, Head of Site Partnership, and Joseph Yeomans, VP Marketing, Clariness
What does clinical trial site success look like?
Did you know, that 50% of sites enroll just one patient, or no patients at all? So, does clinical trial site success equate to recruiting 2 or more patients? Of course not. This stat is an industry average, but not an average that we share at Clariness.
We partner with sites and play the role of a dedicated concierge for patients and site staff, directly scheduling site visits, providing warm transfer, managing referral volumes to site capacity, and so much more. We’re not here to talk about what we do, but rather on the outcomes we measure. Specifically, the top 3 KPIs that our Site Partnership team measures.
Of course, the North Star (KPI) that guides our team, is the percentage of patients who consent to participate in the clinical trials that we support. But what is that made of? How do we get there? Well, among a plethora of metrics that we measure, the 3 that drive the high volume of consented patients on a global scale, these are:
In this brief blog, we’ll discuss the importance of each KPI, the impact each of these has on randomization, what we’ve seen to be typical site-specific service levels, and how they compare to Clariness’ service levels.
In a rush? Jump to the summary. (You’ll miss some great data / insight though)
1. Time to first contact
Imagine you’re online and request more information on a product, service or trial, and you don’t get a response for days, maybe even weeks, would you still be interested by then? Would you have a lower expectation of the service due to the slow time to respond? The Harvard Business Review conducted a study emphasizing the importance of timely follow-up and its impact on conversion rates. The study revealed that following up with a prospect within 24 hours has a 60x higher chance of conversion than any amount of time thereafter.
The time it takes to make initial contact with a patient who has expressed interest in your clinical trial, is potentially the biggest single critical point in enrolling that patient. And making first contact is not just the time it takes to pick up the phone, it is the time it takes to actually connect with the patient and have a meaningful conversation with them to discuss the clinical trial in further detail.
What should we aim for?
When it comes to timing, it’s best to aim for meeting or exceeding patient expectations. Following this rule, will help navigate cultural differences. What we mean by this, is that patients in the U.S. will expect first contact almost immediately, whereas the patients we’ve connected with in Japan, are willing to wait much longer, up to a week in some cases.
So what’s a ‘good’ time to first contact you may ask? Well, from working with 7,000 sites across 35+ countries, a ‘good’ outreach time for sites would be to make first contact within 2 days (unless the patient has specified otherwise, but touch on that later).
How achievable is this?
We understand that sites juggle numerous responsibilities beyond hot phoning / emailing potential patients. Their capabilities are heavily limited by their operational capacity and working hours, which can vary significantly based on whether the site is a small university site or part of an international Site Management Organization (SMO).
That’s why, here at Clariness, we have established an Enrollment Success Team, as the central point between patients and sites, who deliver first patient outreach within 20 minutes in the US, and 1 hour rest of world… and when we say “rest of world”, we truly mean it, we’ve delivered this on a global level.
Pro-tip: Provide patients with a preferred contact time
It’s easier said than done, but what really helps in making contact with patients, is giving them the option to schedule the initial contact with your site staff (or contact team). Unfortunately, for most sites, they are often limited to the working hours of the day, and when site staff actually get the time between patients to outreach new ones, they have limited resources to offer such functionality. Our data shows that on average, it takes sites 17 days to make first patient contact.
Clariness offers this option, creating a calendar event and even providing patients with the name of our agent and contact number to expect, which dramatically increases our ability to reach patients. While it would seem biased, we would strongly recommend using a specialist in patient outreach (such as Clariness), as this not only provides the functionality and resources to contact patients between 8am and 8pm local time, Monday to Saturday and in the patient’s native language, it’s performed by our in-house agents that are trained on the specific protocol of the study in question. If you want to see improved contact times, engagement and enrollment numbers, equip your sites with a specialist to perform this outreach for them.
2. Time to schedule first patient visit
To avoid any confusion, let’s establish clarity from the beginning when we refer to the time to schedule the first patient visit, we’re specifically talking about the duration it takes to arrange the appointment, not the actual date of the appointment itself.
Patients are as human as you reading this; they may have a work schedule, may need to organize childcare, about to take a sunny holiday, in which they return from ready to commit time and focus to a trial that can be quite time consuming.
On average, our data suggests that currently, sites take an average of 30.5 days to schedule the first visit of a patient. In our experience, when Clariness schedules the patient’s visit, the patient’s likelihood of being randomized is tripled. Yes, just getting to the point of scheduled visit, can lead to a 3x increase in the randomization of the patient. The first KPI is reaching the patient to verify their eligibility and willingness to participate, if both are validated, schedule the visit as soon as possible.
What should we aim for?
Again, we understand from working with thousands of sites globally that scheduling times can vary, but again, a ‘good’ standard for time to schedule first visit, one we’ve generalized from our experience, would be 20 days.
Of course, you’re wondering, “How fast could Clariness deliver this?” Well, here’s the scoop… On average, we typically would set a target of 10 days, and this average can be made 40% faster with warm transfer.
Warm transfer is connecting a patient immediately to a site once we have completed the 2nd level of pre-screening. Meaning we pass the patient and their screener responses over to site staff in the same call, so they can continue with their screening and hopefully, directly schedule the patient’s first visit there and then.
We also have the ability to connect with site calendars to directly schedule the site visit without the need to transfer/liaise with site staff, which makes the patient journey even smoother than an instant handover. However, we must note that it can be difficult for sites to opt into this, as while it requires what some would consider to be quite simple digital resources, some sites globally are just not equipped to handle this, so we would approach setting standards on a case by case basis.
Pro-tip: Use warm transfer to reduce your ‘good’ target of 20 days, down to 0 days
If you partner with a patient recruitment vendor that offers warm transfer, remember that scheduling a patient leads to a 3x higher randomization rate, and using a service such as direct scheduling or warm transfer, can reduce a good target, to an unprecedented result, providing an instant handover of a patient to site staff to schedule there and then. On average, of the sites we work with whom use warm transfer, schedule patients 40% faster, as it bridges the time gap between initial screening and the initial site-level screening.
3. Patient outreach performance
If you’re reading this far, you’re showing the level of persistence that we encourage at Clariness to reach a patient. Outreach performance for us, is dictated by the number of attempts made to reach a patient. Much like the 2nd section of this blog, we must reiterate, that patients have their own lives, their own schedules and in some cases their own levels of diary conflicts. If a patient wants to be called on Tuesday at 10am, but their boss scheduled a meeting for the same time, you’ll have to try again, and again, and unfortunately, again, if you want to turn the patient’s interest into a randomization.
What should we aim for?
On average, from our data, sites will typically make up to 3 attempts to reach a patient. Of course, this varies hugely by site capacity, resource, country, condition and other variables including the time of the year.
At Clariness, we make 10 attempts to reach a patient as a minimum. You might wonder what the impact to patient reachability is with so many attempts, or whether we’re wasting our time? Well, from our data, while the majority of patients will respond within 3 attempts (or their preferred times), we still get 20% of our patient referrals from those contacted on the 4th or later attempt (including the 10th!).
If 80% of clinical trials fail to reach their recruitment goals, increasing patient referrals by 20% would be a very welcomed boost, and one at Clariness which we pride ourselves in. It’s also what provides such ROI for the media budget of our clients, because we do not waste a single patient registration.
In fact, our reachability routine, coupled with our tech-powered ClinLife® system, has enabled us to set an industry gold standard of >90% patient reachability. You can learn about that in our press release here.
Pro-tip: The 2nd biggest patient-reported motivation for trial participation is altruism, they’re probably not ignoring you for?
We recently surveyed >4,000 patients across 9 countries, on both the drivers and barriers of trial participation, and 40% of patients reported “Contributing to the well-being of society or the advancement of science” as a driver for trial participation.
Patients at first wish to seek a better treatment for themselves, and in cases where this might not help them in time, or they could receive a placebo, they hope it will help others. Keeping this in mind, will hopefully motivate site staff to pick up the phone one more time, or send that next email reminder.
Driving trial site efficiencies, drives our site-level NPS
Nobody really enjoys being micro-managed, and it would be easy to see how these KPIs and associated activities could come across as overbearing for sites, however, it’s quite the opposite. In running these activities, we create a partnership with sites, we become an extension of their team, take administrative tasks off of their shoulders and let them focus on what they do best, caring for patients.
At Clariness, our relationship with sites on a global level is paramount, which is why we regularly run site satisfaction surveys, and are proud to have a site-level NPS of 80%! For those unfamiliar with the NPS model, the NPS is calculated only on promoters, detractors and even passive responses are not included in the scoring, meaning 80% of sites would actively promote us. Just to give you a glimpse of what this means to sites, see a few recent testimonials from real staff that we’ve supported:
“We have a very large patient database but it is much easier to use Clariness referrals.”
Ronny Bauer, Clinical Study Coordinator
Asklepios MVZ Bayern – Landsberg
“We are very happy with the service and wish the recruitment campaign hadn’t ended so soon.”
Bettina Lippold, Study Coordinator
St. Johannes Hospital
“Clariness is the recruitment solution of the future.”
Bianca Krug-Hoeren, Study Coordinator, Department of Cardiology,
Maria Hilf Clinic
In summary
Time is of the essence, the sooner you contact a patient, and schedule the visit, the higher your chance of randomizing them, and the more successful your site can be. There are many indicators of site performance, more so than the 3 we have discussed here, but to recap on these golden KPIs that will drive your overall patient consent numbers, and what you should be striving for, these should be your goals.
Time to first contact:
- Site-level target, 2 days
- Clariness standard is <20mins US, and <1hr rest of world
Time to schedule patient visit:
- Site-level target, 20 days
- Clariness standard is 10 days, and 6 days for sites with warm transfer
Patient outreach performance:
- Site-level target, 10 attempts
- Clariness standard is 10 attempts, but we have >90% reachability
Should you wish to discuss any of the KPIs with a member of our Site Success team, or see exactly how we monitor these in our ClinLife® portal, please reach out to us here.