Investigator Site Survey

Sep 01, 2010

The quality of clinical trials is highly dependent upon the ability of clinical investigator sites to perform their responsibilities effectively. As clinical protocols become increasingly more complex and clinical development becomes more global in scope, the ability to fully meet the needs of investigator sites is also becoming a more critical factor in ensuring the successful outcome of clinical trials.

Understanding and responding to the daily challenges that sites face, as well as their views on the tools they use to communicate about and manage the study, can also foster a better working relationship between the site, study sponsor, CRO, and central laboratory.

In 2008, ICON Central Laboratories, a global central laboratory provider, surveyed over 9000 investigator sites around the world to obtain more detailed information about the environment in which sites work, the stresses they encounter, and the types of services that might improve the way they manage daily research activities. The survey responses provide interesting trends and insights regarding how study coordinators, in particular, view and/or are affected by:

  • The type of clinical setting in which they work
  • The balance between rendering patient care and conducting research functions
  • The most time consuming aspects of the research responsibilities
  • The means by which they communicate with the study team and central lab
  • Electronic data capture (EDC)
  • The type of support services provided by their central laboratory

These results offer study sponsors, CROs, and central laboratories guidance in how they can refine their services to better support investigator sites as they fulfill their critical roles in the conduct of clinical trials.

Methodology

ICON Central Laboratories' first annual investigator site survey was conducted in May 2008. The survey was disseminated via email to over 9000 sites worldwide using a commercially available Web-based survey software. It included 33 questions, most involved the use of a rating scale as well as "skip logic," which drilled down to additional questions only when previous responses warranted it. The survey also included several open-ended questions to permit elaboration and additional comments.

Input regarding the survey design was obtained from B2B International, an internationally recognized market research firm with experience in the pharmaceutical industry. The survey was conducted in English only. To improve response rate, responders were entered into a drawing to receive one of 15 iPod nanos.