ACURIAN CASE STUDY:
Transcription
ACURIAN CASE STUDY:
ACURIAN CASE STUDY: Predictable, reliable, and measureable results Acurian is Delivering 48% of all Randomizations for a Global Pediatric Depression Program This Phase III, two-protocol program (ongoing) is critically important for a sponsor hoping to extend the label of its antidepressant drug (currently available for adults only) to children and adolescents. The Enrollment Challenges • Children rarely say, “I’m depressed,” and parents may not recognize the symptoms. • Parents may not feel comfortable acknowledging their child’s depression or know how to communicate with their child about depression. • Parents are particularly reluctant to enroll their children into antidepressant studies. • The protocol requires numerous weekly appointments, which could be difficult for busy parents. The Enrollment Scenario • At study start, the goal was to complete enrollment by the end of 2014. • With all the challenges, the clinical trial team soon realized that not only were enrollment timelines unrealistic, but that achieving randomization goals would be extremely difficult, if not impossible, without central recruitment support. • Acurian was hired to work with 100 global sites to deliver 390 randomized patients over 16 months. To date, 66 sites remain in the study. • Currently, Acurian has exceeded sponsor expectations and accounts for 48% of all study randomizations. How we did it Acurian was ideally suited to support this study. Since 2007, we successfully managed 20 studies seeking a younger population and 69 CNS studies. In addition, we have referred over 76,000 prescreened qualified patients with a CNS-related disorder to study sites. The Marketing Campaign After surveying several thousand households about childhood depression, Acurian designed two sets of materials: one for parents of children (7-11) and one for parents of adolescents. Selected materials were customized to country-specific needs, and great care was taken to meet the sponsor’s health literacy standards. The campaign tactics included: • Direct mail (US only) targeted to 7.7 million optedin depression contacts (30% indicating children in household) from Acurian’s proprietary database of 70+ million people. • eRecruitment (online health networks, keyword campaigns, display ads, social networking) • Television, radio, print • Patient engagement and education video to help parents understand and commit to the study • Landing page for online screener (50% of people prefer to screen online) (see other side for campaign results) Campaign Results to Date Currently, Acurian accounts for 51% of all screens and 48% (428) of all randomizations. Months to Complete Enrollment Because Acurian has increased site enrollment rates by +92%, the current level of enrollment has been reached 63% faster compared to how sites alone were on track to deliver. Acurian recruitment of 428 patients .763 patients/site/month Wait for 66 sites to complete enrollment .398 patients/site/month 27 months 44 months or more l l l l l l l l l l l 0 5 10 15 20 25 30 35 40 45 50 Patients Completing Randomized Treatment Analysis shows that the quality of Acurian patients is similar to in-practice patients, with 61% of Acurian patients completing randomized treatment compared to 64% of non-Acurian patients. 100% – 90% – 80% – 165 patients 167 patients 70% – 60% – 50% – Dropped out 40% – 30% – Completed 263 patients 302 patients Acurian Patients (428 Randomizations) In-Practice Patients (469 Randomizations) 20% – 0% – The Cost Efficiency of Acurian To date, Acurian central recruitment has cost $1.5 million less than waiting 44 or more months for sites to find enough patients, and $1.3 million less than adding 40 sites in order to reach the same enrollment volume in the same period of time.* *IMS CRO CostPro® analysis The Enrollment and Retention Specialist Total Cost of Enrollment Option ($Millions) 10% – Cost of Enrollment Options 8 – 7 – $7.2 M $7.4 M $5.9 M 6 – 5 – 4 – 3 – 2 – 1 – 0 – Add 40 Sites (106 Total) Wait for 66 Sites to complete enrollment Acurian Recruitment of 428 Patients COMPLETE ENROLLMENT WITHOUT ADDING SITES OR TIME Acurian, Inc. is the global leader and industry specialist offering ways to enroll trials faster and more cost efficiently. We do this by consistently giving clinical trial managers more randomized patients-per-site, faster enrollment, and lower costs. For over 15 years, our comprehensive solutions have helped sponsors efficiently enroll and retain the patients they need, when and where they’re needed. www.acurian.com