A Case Study: Balanced Site Performance Leads to Shorter Timelines and Lower Costs

Background:It is common knowledge in the clinical trials industry that within any given multi-site study, 20% of the sites will enroll a maximum of one subject, and often none at all, while the top 20% enroll the majority of the subjects. Over 85% of all studies fall behind their intended enrollment timeline.

Clinical Site Services (CSS) recognizes that site performance is the number one issue, not patient recruitment. Sponsors and CROs do not provide the necessary support to sites to help them meet and exceed their screening and enrollment goals. CSS believes in developing the right enrollment “tools” and provides unique customized services to assist sites in identifying subjects for their trials and increase their overall effectivness.

Solution:In a recent overactive bladder (OAB) study, CSS worked with the CRO prior to the study start up to develop tools which sites could use to reach out to the OAB population. These tools included in-office awareness materials, community awareness, and advertising outreach. CSS worked with each site to develop an enrollment plan which included tactics that would best meet their needs. Once the study began, CSS worked with each site to execute their enrollment plan, monitoring the success of each tactic.

Solution #1 – Enrollment Tools By providing the sites with the right tools, developing enrollment plans, and supporting each site with enrollment support services, the screening goals were met within 37% (at week 10) of the planned timeline of 27 weeks. Providing sites with the right tools and support services increased the percentage of sites screening thus shortening the timelines.

Tools Created:

In-office awareness materials:

• Doctor-to-Patient Letter
• In-office 70” awareness banner
• Study criteria cards

Community Awareness tools:

• Brochures & Flyers
• Study Website
• Study easels and cards

Outreach Tools:

• Television
• Radio
• Print
• Internet messages

Solution #2 - Support Services Each site was assigned a Site Enrollment Specialist who worked with the sites to develop a custom enrollment plan utilizing the study tools developed to their enrollment needs. The Site Enrollment Specialist worked with each site on a weekly basis to make sure their enrollment plan was being implemented and to assess the results of each tactic.

Results By working with each site to execute their enrollment plan, 100% of the sites had screened at least six (6) subjects. While the top 20% of the active sites still over performed, having the remaining 80% contributing a significantly greater amount put the study ahead of its timeline goals by more than 17 weeks.

Results: Overall Benefits

• Study timelines are met
• Costs are kept to a minimum
• Sites are more compliant and motivated when actively screening
• Sponsor was able to monitor the sites’ progress and make informed decisions throughout the study

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 an d 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.

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.

Sites are losing enrollment opportunities

Typical Site Challenges:

• Lack of advertising expertise –knowing where to place advertising for maximum benefit
• Lack of time – Coordinators lack the time to recruit effectively
• Call handling – most sites rely on voice mail to handle calls

Project Synopsis

CSS supported sites for a national type 2 diabetes study. One site located in Baltimore Maryland was having challenges finding patients for their Diabetes trials. Prior to using CSS planning services they used their $3,500 media budget in their local newspaper, where they have place their advertising for years. The study coordinator had no experience placing media and limited time to research her options. She also did not have time to speak with non interested and non qualified callers. The site had placed a 3 x 5 inch ad in the local newspaper which had limited results and most calls that were generated came in before and after office hours. They needed to generate more calls with their limited recruitment budget.

Project Approach

CSS did a detailed review of the protocol and their geographic/demographic area. We also reviewed their recruitment materials for effectiveness and defined the best target audience for the study. The Sponsor approved a recruitment plan and budget that CSS developed which was based on the media habits of people with diabetes and the defined target audience. CSS worked with the study coordinator to determine the best weeks to run ads as well as time of the day so she could handle the calls that were generated.

Project Results

Conclusion

• The site was able to screen more subjects from the increase of interest
• The study coordinator was less frustrated with her job
• The Response rate was over two times more and the screenings increased six times
• 100% calls handled and pre-screened
• Sponsor had metrics for future decisions