This sponsor was in a highly competitive race to complete a 6-protocol program for approval of two new COPD drugs.
The Enrollment Scenario
- The competitive landscape for sites and patients was saturated, and the sponsor was competing across its own protocols, as well as against competitors’ COPD programs.
- Staggered protocol start-ups created significant logistical challenges.
- A 40% screen fail rate was anticipated based on the sponsor’s past study experiences. However, changes in US spirometry evaluations were resulting in an average screen fail rate of 65% across sites.
- The sponsor realized that not only would it be impossible to complete enrollment of each protocol within six months as hoped, but that there were simply not enough patients available through site efforts alone.
- Central recruitment support was essential to completing the study. Acurian was hired prospectively to support the two safety protocols, and for rescue of the other four protocols (as needed).
How We Did It
Acurian designed a full-service program strategically adjusted to each protocol’s start and stop dates
- Direct mail targeted to potential patients within Acurian’s proprietary database of 70+ million people with self-reported health related conditions and who had opted-in to be contacted for clinical trials (~3 million COPD sufferers).
- eRecruitment tactics (social media, online health networks, keywords, etc.).
- Print and TV ads in select markets.
- Project managers deployed campaigns according to the sponsor’s prioritization of protocols.
- Acurian’s Enrollment Optimization Representatives personally visited selected sites and worked directly with study coordinators to increase site participation as a part of our recruitment efforts.
- All sites were provided with useful tips, tools, fact sheets, and a summary of our pre-screening activities.
- Acurian had a heavy presence in the investigator and site rejuvenation meetings.
Tiered site marketing for maximum cost-efficiency
- Acurian ranked sites based on referral-to-consent performance and focused campaign investment and resources on the best performing sites.
- We contributed a significant 35% of all enrolled patients to the program.
- Our randomization contribution ranged from 26%-46% across protocols.
- Enrollment would not have been completed successfully without Acurian’s participation.
The Cost Efficiency of Acurian
An IMS CostPro® analysis was conducted to compare the cost of this central recruitment program vs. adding more sites (as an option for completing enrollment).
- Given the difficulty in finding enough patients, the sponsor would have had to add another 248 sites (65% more) at a cost of almost $16 million – a costly and unpredictable option.
- Acurian was able to deliver enough randomizations to complete enrollment for $3.5 million less than the cost of adding sites.