Quintiles' Phase I Unit Tackles Trial 'Shopping'

Clinical trial recruitment and enrollment has presented its challenges in many ways.  For Quintiles’ Phase I Unit in Kansas, clinical trial recruitment was a matter of process and strategy that it improved with innovation and mobile health (mHealth) technology applications. This article and case study will delineate the challenges that Quintiles’ Phase I Unit underwent, and what it did to achieve transformative results in recruitment, study visit adherence, and operational efficiency.

The Challenge: Attractive Studies Are Attractive to Patients

Quintiles’ Phase I Unit exhibits a similar operational infrastructure as a study site; they initiate many studies, seek out patients, and enroll them in clinical trials.  Moreover, this unit has established a digital community of highly engaged patients that receive information about new clinical trials (see http://www.studyforchange.com/ and Study for Change Facebook Page; generating between12,000 – 17,000 visitors per month).  In addition to these digital sites, the unit regularly executes advertising campaigns including radio ads, emails, and social media campaigns to landing pages that generate several thousand monthly interest referrals with a nearly 75% pass through rate.  

Due to the high amount of simultaneously running studies, the Phase I Unit was faced with competing clinical trials, which affected equivalent patient recruitment rates across all studies; “the studies started cannibalizing each other,” said Benjamin Sieve, Clinical Trial Marketing Coordinator at Quintiles.

The Phase I Unit observed that some studies were enrolling very rapidly, leading to waitlisted patients, whereas other studies were enrolling at lower rates.  Factors associated with study design which affected enrollment included study duration, time commitment, and patient stipend amounts.

With its traditional approach, Quintiles was equivalently campaigning for all of its studies, and when patients exhibited interest in screening for a specific study, they would be scheduled for a screening appointment (Visit 1), however, dropped out prior to arriving at the clinic.

Figure 1 illustrates that patients dropped out of studies less likely to enroll because they had subsequently become aware of alternative studies through Quintiles’ recruitment website,  This resulted in overcrowding these studies, leading to high levels of waitlisted patients, while leaving other studies with less patients and lower enrollment rates.

Figure 1: Traditional Approach

(click to enlarge)

Featured Studies Approach: Equal Trial Opportunity

After discovering the root causes of uneven patient distribution, the Phase I Unit considered a different approach in patient allocation: Featured Studies.  The Phase I Unit determined that since patients naturally veered towards certain studies, the unit decided to focus more campaigning resources to feature the studies that were not enrolling as frequently as others.  Figure 2 illustrates the Featured Studies approach.

Figure 2: Featured Studies Approach

Results from the featured study approach were breakthrough.  Figure 3 demonstrates that study visit attendance rates at screening rose from a daily average of 64% to 75%.  “The Featured Studies approach allowed us to recruit patients who are genuinely interested in studies that had difficulty with enrollment; that had a dramatic effect on study visit attendance rates at screening (Visit 1).”

Figure 3: Attendance Rates before and After Featured Studies

Optimizing Operational Efficiency with Text Messaging

The Quintiles Phase I Unit was faced with another challenge: how to improve operational efficiency in getting patients to attend their screening appointments (Figures 1 and 2).  The Phase I Unit was initially reminding patients by calling them up to two times prior to their scheduled study screening visit.  “It was a big challenge to remind patients of their study screening visits with phone calls; it was resource intensive, we would leave voice messages and there was no way for us to confirm appointments if they didn’t pick up the phone,” said Sieve.  “This issue made it impossible to coordinate in-processing staffing and resources,” added Sieve.

In 2013, the Phase I Unit leveraged Mosio’s customized text messaging (SMS) solution to remind patients of their study screening visits.  Figure 4 illustrates the actual impact of text messaging with study visit attendance rates at screening, whereas Figure 5 demonstrates the statistical impact of the amount of SMSs sent daily on study visit attendance rates.

Figure 4: Study Visit Attendance Rate VS SMSs Sent

Figure 5: Statistical Impact of SMSs on Study Visit Attendance

Figure 4 illustrates that the amount of daily SMSs sent appears to be positively correlated with study visit attendance rates, and Figure 5 confirms that, when regressed, 175 average SMSs sent per day is statistically associated with a 10.07% average increase in study visit attendance (P<0.0001, R = 0.29).

The solution offered unprecedented benefits in operational efficiency including (1) a 91.6% reduction in resources used to remind patients of their study screening visits, and (2) an ability to optimize study screening department resources because of visit confirmations.  “With text messaging we can confirm, cancel and reschedule appointments, and this allows us to adjust our screening department for processing,” said Sieve.
 

Innovation is Changing Clinical Operations: A Shift in Culture?

This case study demonstrates that the industry is starting to shift its approach and culture towards improving clinical trial outcomes.  Applying novel methodologies to ameliorate clinical business operations, and enhancing patient engagement is merely the start towards a new paradigm in clinical research. 

"Patients are at the center of the work we do and engaging them directly with a variety of solutions, including innovative technology, is an important part of Quintiles’ expertise," said John Reites, Head of Direct-to-Patient Research, Health Engagement & Communications. "As technologies for patient engagement advance, we continue to innovate their uses to provide a richer patient experience and enable new methods for collecting insights, digital health device and mobile-generated data directly from patients."