Investigator Site Survey - Applied Clinical Trials


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Investigator Site Survey

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Eight Months Later

The Author's Thoughts

Anthony Graziosi Associate Director of Site Services ICON Central Laboratories Farmingdale, NY
As a global central laboratory, providing quality support to investigator sites is a key part of the service we provide to study sponsors. When we initiated our first investigator site survey in 2008, we wanted to do more than seek feedback about service levels. We wanted to use the survey instrument to begin to better understand the environment in which site personnel, and particularly study coordinators, function. In broadening the scope of the survey, we hoped to hear first hand what the day-to-day challenges are for sites and how they view the tools and processes. When we received a surprisingly high response rate to the survey, we realized that sites are looking for a voice. As a result, we decided to write the article that appeared in the January 2010 issue of Applied Clinical Trials to give the respondents' views a broader audience and hopefully make the deliverables that sponsors, CROs, and central laboratories offer to sites more congruent with sites' needs and expectations.

The fact that this article became one of the most retrieved articles from the publication's archives underscores the industry's recognition that sites are a critical factor in conducting successful clinical trials. As site recruitment becomes more competitive, the most successful sponsors, CROs, and central laboratories will be those that can address site needs. This article also trended responses to give a better idea of regional differences in how sites view various aspects of clinical research operations. With our industry's growing emphasis on global trials and its focus on cost effective trial management, it is likely that readers found this information particularly relevant and instructive as they plan for future studies.

As a result of the valuable information we obtained for our own business operations and the apparent value that it has had for the industry, our company has made this survey an annual business activity. We look forward to providing similar updates on site perceptions and trends in the future.

The Advisory Board's Take

Timothy Callahan Chief Scientific Officer Biomedical Systems Saint Louis, MO
In May of 2008, ICON Central Labs surveyed over 9000 investigator sites around the world to obtain more detailed information about the environment in which sites work. The results of the survey appeared in an article in the January 2010 issue of Applied Clinical Trials, which has since become one of the publication's most read articles. Rarely has such a large project been undertaken.

The survey was Web-based. ICON asked 33 questions, with topics such as the type of clinical setting, balance between patient care and research, what consumes the most time, communication techniques, electronic data capture, and support services.

The respondents' rate was 24 percent. Of those who responded, 85 percent were study coordinators, and mostly U.S.-based, although study personnel around the world responded to the survey.

What makes this such an important article is not only the number of sites who responded but the rigor in which the survey was conducted, including the type of information conveyed by the participants.

For those of us who remember clinical trials before the widespread use of computers and electronic data capture, it is enlightening to see the reliance on computers by investigational sites. The Internet, which once was thought to be unreliable and not secure, has now become indispensable in the conduct of clinical trials. Only 3 percent of the respondents were considered "Not Computer Adept" (based on a set of pre-defined criteria).

The study also shows disparities in respondents by location. For example, when asked if they had attended an investigator meeting and heard a lab presentation, 74 percent of the U.S. study coordinators responded "yes" while only 55 percent of the non-U.S. study coordinators responded similarly. These disparities in respondents are valuable in efforts to standardize operations in clinical trials.

More than just providing interesting trends and insights regarding how study coordinators work, this article gives an investigator site perspective on how clinical research is carried out to those of us who are not, on a day-to-day basis, involved in the collection of research data. This article, in many ways, can be used as a template for training and understanding how our data is collected at the patient level. It will be very interesting to follow the trends of these responses over time. The authors are to be congratulated.

Anthony Graziosi , MBA, is Associate Director of Site Services at ICON Central Laboratories, 123 Smith Street, Farmingdale, NY 11735, email


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As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
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