Case Study: How much does TIME cost you?

Situation:        A large pharmaceutical company was having challenges with enrollment for a major digestive disorder trial. Their rate of enrollment was averaging 10-14 per month with over 75 sites across the county and was on track to complete enrollment in August of 2008--- 13 months behind schedule. CSS was contacted to provide a solution to the increase the rate of enrollment and help complete enrollment as quickly as possible.

Solution:         Within four weeks, CSS developed and began a multi-tactic Site Performance approach to this enrollment challenge. The first step was to redevelop the creative advertisement to better target the appropriate audience. The second step was to equip the sites with the recruitment tools and keep the coordinators informed through monthly teleconferences. The third step was to manage multiple, localized strategic site recruitment campaigns customized to each site.

Results:           Through the study coordinator communications efforts, a robust site support call center, revised recruitment tools and the targeted recruitment campaign, the sites’ monthly enrollment rate increased by 500% and the trial completed 14 months ahead of the historic enrollment pace. This customized site performance campaign saved the sponsor over $6,000,000 in trial expenses and expedited the time-to-market of the product.

Increasing Site Performance Case Study

In today’s reality of meeting enrollment goals, the Pareto principle of 20% of the sites enrolling 80% of the study subjects seems to hold true for most studies. This reality puts a lot of strain on the “performing” sites and ends up costing the sponsor delays in their timeline and instituting expensive patient recruitment campaigns.

Situation:
CSS was approached by a large CRO to assist them with increasing enrollment on a large, 79 site nation-wide trial. At the time CSS’s services began, 30 weeks had lapsed, less than 20% of the sites had screened three or more subjects, and only 64 patients were enrolled.

Challenge:
The client needed to increase the number of sites screening and enrolling, generate more screenings from private practice and recruitment, increase the enrollment rate, and complete the study within nine months.

Solution:
CSS developed an integrated Site Performance Strategy to meet the client’s goals. The components included:

1. Site Assessments
2. Patient Awareness Tool Kit
3. Monthly Study Coordinator Teleconferences
4. Site Assistance Services
5. Customized Site Recruitment Planning
6. Recruitment Ad Development
7. Patient Recruitment Campaign Execution

Results
The site performance campaign ran for 28 weeks and enrolled 326 subjects to complete enrollment one month ahead of the client’s goals. By increasing the number of performing sites, study budgets were used more effectively and enrollment was completed earlier than scheduled.

 

                                    Prior to         Site Performance
                                       CSS            Strategy Program
Weeks                               30                          28
Total sites                          79                          79
Total Screening                 117                        535                     457% increase
Sites screening 3+            15 (19%)                55 (70%)          
Total Enrolled                  64 (16%)               326 (84%)          
Avg. # Enrolled/site            .81                        4.13                    509% increase

Compliance and Retention Case Study

Situation
A major pharmaceutical company was having challenges keeping subjects retained during a seven month, seven visit study. Subjects were forgetting to fill out their diaries and many were dropping out or were lost to follow up, with the drop out rate at nearly 50%. The study needed 500 subjects to complete enrollment.

Approach
A compliance plan was developed to keep the subjects interested in the study and enforce the importance of filling out the study diary. A retention program was also developed to decrease the drop out rate by reminding the subject of their next study evaluation visit at the site and their importance to this study.

Solution
The Compliance Program was comprised of multiple tactics to support the diary compliance goals. First, a website was developed to provide study subjects information about the study, their illness and provide a venue to share personal experiences with others participating in the trial. Weekly emails and monthly letters were sent to enrolled subjects that had specific messages depending on their progress within the study.

Two tactics were used to increase the retention rate for this study. One week prior to each study visit, an outbound call was made to the study subject to remind them of their scheduled visit and other visit information, if necessary (for example bringing medication lists). Once they completed the study visit, the study coordinator gave them an “appreciation” gift and appointment reminder card for their next visit.

Results
As a result of the Compliance and Retention programs, the rate of dropouts was nearly cut in half.

Conclusion

• The cost of these retention and compliance programs was $76,000
• This study was completed four months earlier than previously forecasted with the high dropout rate
• The cost to obtain and support a completed study subject averaged $12,000. By decreasing the drop out rate, the sponsor realized over $780,000 in savings by not having to identify additional study subjects to replace those who had dropped out

Retention and compliance is just as important as enrolling subjects into a trial. By planning and budgeting these programs in advance, timelines and budgets can be dramatically minimized.