When you can`t afford a delay in patient enrollment,
Transcription
When you can`t afford a delay in patient enrollment,
When you can’t afford a delay in patient enrollment, Acurian is the only viable option for keeping enrollment on track. We deliver the patients you need, when you need them, at the price we quoted. When you can’t afford a delay in patient enrollment, you can’t afford NOT to use Acurian Especially when you compare these costs… ✓✓ Missed key milestones ✓✓ Delayed time to market ✓✓ Adding more sites, countries ✓✓ Time and money wasted on novice recruitment suppliers …to the value of Acurian ✓✓ The patients you need, when you need them ✓✓ More patients per site ✓✓ Sterling track record of on-time enrollment performance ✓✓ Results-based pricing that is often less than adding sites or time In the following case studies, Acurian used IMS CRO CostPro® analyses to demonstrate that not only did Acurian quickly get patient enrollment back on track, but as a replacement cost for other options, was significantly more cost-effective. Acurian Saved Eight Crucial Months of Enrollment Time for a Global Gout Program This phase III global program was critical for the sponsor, as it was striving to make its compound the leader in a potential $1B gout market by 2018. After five months of enrollment, sites‘ databases were exhausted. All sites were significantly behind in enrollments. Months to Complete Enrollment Acurian enrollment of 525 patients 17 Months Wait for 252 sites to complete enrollment Acurian was hired to support 252 sites in the US and 100 sites in five other countries. Acurian worked closely with the sponsor’s two CROs and exceeded expectations by delivering 30% of the study’s randomizations. 25 Months or More l l l l l l l 0 5 10 15 Months 20 25 30 Cost of Enrollment Options 14 $12.4 M $13.1 M 12 $9.3 M 10 $ Millions The Cost Efficiency of Acurian Acurian cost $3.8 million less than waiting 25 or more months for sites to find enough patients, and $3.1 million less than adding 108 sites, which would have been required to reach the same enrollment volume in the same period of time. 8 6 4 2 0 Add 108 Sites (360 Total) Wait for 252 Sites to complete enrollment Acurian Thanks to Acurian, This Sponsor Won its Race to Market with a New Class of OIC Drug For the sponsor, the financial stakes were enormous. Being first to market could mean capturing a major slice of a multi-billion dollar pie. Hence, every day counted. Acurian was hired at study start to accelerate enrollment. We supported 401 sites, increased the site enrollment rate by 77%, and delivered 44% of all patients. Months to Complete Enrollment Acurian enrollment of 924 patients 14 Months Wait for 401 sites to complete enrollment All subsequent timelines were met. The drug received FDA approval, and the sponsor was able to leapfrog its major competitor to market. 25 Months or More l l l l l l l 0 5 10 15 Months 20 25 30 Cost of Enrollment Options $30.0 $25.6 M The Cost Efficiency of Acurian Given the actual in-practice site enrollment rate, the sponsor would have needed to activate another 310 sites to meet its randomization targets in 14 months. $ Millions $25.0 $20.0 $15.0 $10.9 M $10.0 Acurian was able to deliver enough randomizations to complete enrollment for $13.9 million less than the cost of adding sites. $5.0 $0.0 Add 310 sites (771 total) Acurian Acurian Rescued a Cardiovascular Outcomes Mega-Trial Long-duration trials are tough on enrollment rates, and this study was no exception. The sponsor planned for 20,581 patients from 881 sites over seven years. However, at year six, sites had lost steam and a significant shortfall of 1,986 patients at the end of year seven was projected. Acurian was hired at the end of year six to revitalize study enrollment by supporting 271 of the 881 participating sites with patient recruitment for one year. In one year, Acurian increased the site enrollment rate by 343%, which avoided a two-year delay. Years to Complete Enrollment Acurian added at year six to assist 271 sites 6 Years Wait for 881 Sites to Complete Enrollmentt 1 Year 9 Years l l l l l l l l l l 0 1 2 3 4 5 6 7 8 9 Cost of Enrollment Options $140 $120 $100 $ Millions The Cost Efficiency of Acurian Acurian cost $107.2 million less than waiting for sites to complete enrollment. $119.2 M $80 $60 $40 $20 $0 $12.0 M Wait 2 additional years for 881 sites to complete enrollment Acurian Acurian Completed Enrollment 113% Faster Among US Sites to Rescue a Global Diabetes Study This was an important Phase III clinical trial designed to confirm efficacy and safety of the sponsor’s compound. In the US diabetes market, even the capable sites were struggling to find enough patients in the face of very specific enrollment challenges. The enrollment rate was much lower than anticipated, and timelines were in significant jeopardy. Acurian was hired to provide recruitment support for two months, then for another two months. Months to Complete Enrollment Acurian enrollment support Wait for 70 sites to complete enrollment Enrollment was accelerated by several months. Acurian exceeded its commitment (105% of goal) and delivered 120 randomized patients within budget. The Cost Efficiency of Acurian Acurian cost $2.7 million less than adding 125 sites which would have been required to reach the same enrollment volume in the same period of time. (Based on US site productivity 17+ months l l l l l l l l l l 0 2 4 6 8 10 12 14 16 18 Cost of Enrollment Options $8.0 $7.0 $7.0 M $6.0 $5.0 $ Millions •Increased the site enrollment rate by 94%. •Contributed 48% of all patients enrolled in the US. •Enrollment was completed 113% faster compared to how sites alone were on track to deliver. 8 months $4.3 M $4.0 $3.0 $2.0 $1.0 $Add 125 sites (195 total) Acurian 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. When you can’t afford a delay in patient enrollment www.acurian.com [email protected] 215.323.9000