Targeted/Risk-Based Monitoring

CASE STUDY: Targeted/Risk-Based Monitoring

DESCRIPTION: Targeted/Risk-Based Monitoring on three-part study successfully improved efficiency, reduced costs, and completed enrollment and database lock within Sponsor’s timeline.

THERAPEUTIC AREA: Pediatric Endocrinology

SERVICES OFFERED: Project Management, Clinical Monitoring, Site Monitoring, Data Management, and Site Selection

THE STUDIES:

• The first study that WuXi Clinical was awarded in this program was in pre-pubertal children with a specific endocrine disorder. The study enrolled 64 subjects and was conducted at 25 US sites, of which approximately 80% were originally institutional sites, each subject to a Local IRB.
• The second study is an open-label, long-term extension of two previous studies. We provided recommendations that saved the Sponsor several hundreds of thousands of dollars while continuing to provide the same high quality of service and data that the Sponsor had come to expect on the first study. This study is currently being conducted.
• The third study is a global Phase III study in pre-pubertal pediatric subjects. The study will be conducted at 60 sites in North America, Western Europe and Central Europe. As with the previous and nearly all clinical studies, this study had its unique challenges. These included aggressive study start-up timelines in several countries and sample distribution of subjects.

CHALLENGE: The first study targeted pre-pubertal children with a specific endocrine disorder. One of the greatest challenges, given that most of the sites are slower-starting institutional sites, was the six-month enrollment period expected by the Sponsor. The Sponsor, well aware of the limitations of using institutional sites, anticipated that of the 25 sites initiated, only 20 will likely enroll. The ages of the subjects and frequency of study visits made subject retention a potential risk.

ACTION: Targeted/Risk-Based Monitoring plans were implemented on this study to improve efficiency, focus on critical data points, and to reduce costs. We compensated for the shorter enrollment period by identifying large, private, community-based sites where a sizable population of affected children are treated to supplement enrollment at the slower-starting institutional sites. We worked with the Sponsor to identify age appropriate tools they can provide sites to use for entertaining subjects during their visits (e.g., coloring books, stickers, modeling clay, personal DVD players, movies, video games, MP3 players, computers, etc). We also worked closely with the Sponsor and site personnel to mitigate the difficulty some parents and/or caregivers may face in getting the child to the clinic for scheduled study visits (e.g. work schedule conflicts, lack of transportation, insufficient funds to cover transportation, parking, etc.). We worked with sites to identify when/if any of these factors become a concern and how to overcome the issues. We also worked with the Sponsor to provide sites with vouchers, transportation or other compensation to be used when necessary to help alleviate some of the extra burden.

RESULT

By working closely with the Sponsor, we were able to complete enrollment and database lock within the study timelines. Due to our collaborative style in working with the sponsor to overcome obstacles and mitigate risks, as well as to the extraordinary effort we made to enroll 64 subjects within six months, the sponsor awarded us two additional studies in this program.

One of the major reasons for which we were selected for the third study is the continuity in personnel across the three studies that we provided. We worked closely with the Sponsor to determine which personnel could be shared across two or three studies and roles for which WuXi Clinical staff should be unique to each of the studies in order to optimize continuity without overburdening or over-utilizing specific WuXi Clinical team members. We worked closely with the Sponsor to determine which lessons learned from the previous two studies should be applied to the third study.

QUOTE FROM SPONSOR

“I remain very pleased with the quality of service we receive through our partnership with RPG. I think project ownership is nicely displayed by the entire team and I never have the sense that the team feels that they are working on just another project but that they want to see success just as we do at (Sponsor).”