CA SE STUDY NO. 3
Continued from page 15
Results
S4 was able to recruit its full target population in a timely
manner: 82 individuals were recruited to participate in S4
[Table 2] within 21 months. Although recruitment for the
trial took three months longer than originally projected, the
S4 Steering Committee considered this to be successful,
particularly considering the harder-to-reach target population
and complex protocol.
Conclusion
While a comprehensive site selection process may require a
significant investment of time and resources at the outset, the
benefits may outweigh the long-term risks (e.g., study delays,
additional financial resources, high attrition rates, inability to
meet enrollment goals). 8 Developing a checklist such as the
one used by the S4 Steering Committee can facilitate the site
selection process and lead to more open lines of communication
between study sponsors and sites. Sites have an opportunity to
share their interest, background and experience, and sponsors
can dig deeper into questions they may have about the ways in
which the protocol and operating objectives align. 9
Chapter 2
Key Takeaways
+ + Involve sites as stakeholders early in the study design process to help
identify potential challenges and opportunities as they pertain to
study feasibility and patient acceptability.
+ + Use insights provided by sites and other stakeholders to identify and
prioritize site characteristics.
+ + Develop a template or questionnaire to facilitate site assessment and
selection process.
8
9
16
Harper, Beth and David Zuckerman. “Critical Success Factors for Planning for Planning for Site Selection and
Patient Recruitment Planning.” BioExecutive International (2006) pg.16
Harper and Zuckerman, pg. 17
Accelerating Clinical Trials: Best Practices for Recruitment and Retention