Letters to the Editor

August 1, 2002

Applied Clinical Trials

Readers write in with questions and comments about articles and editorials.

Biases in site surveys
When we read the June article Measuring Investigator Satisfaction by Dr. McClelland and colleagues at Roche, we were delighted to learn that Roche supports an ongoing process assessing its relationships with investigative sites. Indeed, CenterWatch has encouraged sponsors to implement these mechanisms since our company first began conducting its sponsor-site relationship quality surveys in 1995.

We were also pleased to see that Roche used CenterWatch benchmark data for comparative purposes. The authors rightly point out the many differences between their methodologyan in-depth telephone surveyand the CenterWatch direct-mail survey approach. The shortcomings of our methodology have been well documented by CenterWatch. We do want to convey, however, the significant response biases that can come from company-directed surveys unless they are implemented carefully. Specifically, investigative sites tend to be far more positive in their ratings when they are confronted directly by sponsor company representatives. Roche reported, for example, that 93% of its sitesvirtually all of its sitesprovide an aggregate satisfaction level. This compares with only 54% of sites in the CenterWatch survey that provide a similar satisfaction rating for Roche. The companys approach also fails to provide confidentiality and anonymity for investigative site respondents. As such, investigative sites may feel pressured to respond, and to do so with flattering ratings. For these reasons, we believe strongly that a third and independent party is essential to gathering more objective feedback.

The authors also commented about the sample size differences between the Roche and CenterWatch surveys. The ambitious goal for our annual site survey instrument is to obtain ratings across all major pharmaceutical and biotechnology companies and to gather a significant sample size for individual sponsor ratings. We ask the sites to specifically name and rate the three sponsor companies that they work with most frequently. Sites typically list the companies that are most memorable, and many sponsor companies are not mentioned with significant frequencyin this case, for example, only 15 of our 405 investigative site respondents mentioned Roche. In some of these cases, CenterWatch has been asked to conduct follow-up surveys where additional investigative sites are solicited and added to the analysis.

CenterWatch has been conducting independent benchmark research on the relationships between sponsors and investigative sites for more than eight years. This research has yielded reliable and consistent measures over that time period. During the past two years, we have actively assisted numerous pharmaceutical and biotechnology companies in creating and executing systematic mechanisms designed to measure sponsor site relationship quality on an annual basis and even on a project-by-project basis. Strong sponsor site relationships can have a profound impact on drug development performance. We are delighted to see so many sponsor companies investing in the development and implementation of feedback mechanisms to routinely measure relationship quality with their investigative sites.

Mary Jo Lamberti, PhD, Victor Chin, and Drew WhalenCenterWatch Market Intelligence Services

Process improvement
In todays business world, we need to consistently look for process improvement and continue to learn from each other. The differences between a project manager in other technical industries and a clinical project manager should be less defined. An understanding of project management knowledge areas and how to map these knowledge areas to project management processes and process groups are basic tools that are useful in any industry.

The new distinction of a project manager with clinical trial experience and project management knowledge and tools requires industry executives to understand and recognize the importance of these skill sets, and what this knowledge and experience will bring to their clinical trials. These individuals must be empowered to develop project teams who can integrate these tools and skills and execute successful clinical trials. Executives must be open to the possibility that although the processes used may change, the deliverables from the team can be the same.

Skepticism remains about process improvement, but it is necessary to improve the clinical trials business. Technology changes and public awareness of clinical trials have increased, so we need to improve our processes and adapt to the changing risks, constraints, and challenges that developing therapies face.

Clinical project managers should welcome the opportunity to learn the tools, the techniques, and the wealth of information that is available for all project managers. Once the information becomes a part of our domain, we can develop ways to implement these new skills in how we plan our clinical trials, how we communicate, and how we perform our daily tasks.

Even if we think we know the best-practiced way for a simple task to be performed, a flow diagram of all the activities that go into that task, step by step, may uncover a way to improve it. It may be a simple step that when added would enhance our quality, or perhaps a simple change in the sequence of steps could save time and/or reduce our cost.Spending the appropriate amount of time planning, determining project risks, and understanding the metrics for measuring the project task by task, can make decision making a win-win process. And that is an improvement we should all accept.

Sandi ParsonsClinical Operations Consultant