<back
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Sites rate Novo Nordisk, Roche, Amgen on top” by Karyn Korieth and Annick Anderson, which appears in The CenterWatch Monthly, June 2011 issue.
A new CenterWatch survey shows sponsors have improved their relationships with investigative sites during the past three years as they increasingly focus on strategies to improve site quality and performance. Yet the average sponsor continues to fall below the performance expectations of sites in several critical areas, including project management and study initiation activities.
In the survey of sites around the world six companies came out on top: Novo Nordisk, Roche, Amgen, Bayer, Abbott Laboratories and AstraZeneca. Three additional companies—Eli Lilly, Takeda and Novartis—also received high scores.
The 2011 CenterWatch Global Site Survey asked 1,205 principal investigators, sub-investigators and study coordinators about the quality of their relationships with sponsors, based on 29 relationship attributes. A total of 16 sponsors with sufficient sample sizes were included in the analysis.
Novo Nordisk received the highest “excellent” score for overall relationship quality (61%) and was consistently rated highest across most relationship attributes. It earned the top spot by creating partnerships with sites, improving communication and making sure everyone involved in the clinical trial process—including study coordinators and CRAs—understands the importance of his or her role in developing new treatments.
Sponsors received the highest ratings for general project management and overall staff professionalism, and 54% of sites thought communication between investigators and sponsors has improved. “The site relationship piece is of paramount importance,” said Jeffrey Kasher, Ph.D., vice president of global clinical development at Eli Lilly, which received a 61.6% “excellent” score for maintaining open communication with sites.
But sites said sponsors are not meeting their expectations in setting realistic project timelines, providing good protocol design, being organized and prepared and paying fair grant payment amounts; in each of these areas, gaps of more than 20% were reported between the importance sites placed on the attribute and overall sponsor performance.
Going global
While sponsors have adopted different sourcing models to staff global trials, top-rated sponsors have established processes that help ensure consistency across clinical trials operations and build strong relationships with sites.
At Amgen, which has 24 offices across the globe, Elspeth Carnan, Ph.D., executive director of global clinical site management, credits the adoption of a functional service provider (FSP) model with bringing greater standardization to global clinical operations and improving the professionalism and quality of its CRAs. “We’ve got a global CRA workforce that is all working to the same standards.” Sites rating the professionalism of Amgen’s CRAs “excellent” jumped from 51% in 2007 to 61% in 2011.
Improvement needed
Top-ranked sponsors have narrowed the almost 20% gaps between the importance sites place on project management and study initiation and sponsor performance, by improving communication with sites and conducting in-depth feasibility assessments to help set realistic project timelines and patient enrollment goals.
Eli Lilly, which saw its general project management score jump from 38% in 2009 to 57.5% in 2011, initiates dialog with sites early in the study process, discusses feasibility with specific sites when developing the protocol and sets clear expectations about timelines and quality.
66% of sites rated study initiation, which includes the investigator meeting and contract negotiation, “very important,” yet only 48% rated the average sponsor “excellent.”
At Novo Nordisk, which had the highest “excellent” score in study initiation at 58.2%, the project manager begins training and feasibility work for the study at least nine months before the first patient visit.
57.4% of sites said informative investigator meetings are important. Here, the importance/performance gap has narrowed to 5.23%, as sponsors have listened to site suggestions. Novo Nordisk and Eli Lilly maintain that holding face-to-face investigator meetings is an important way to establish strong relationships and communication.
“What we heard loud and clear was that investigators were tired of ‘death-by-PowerPoint’—just going over details of the protocol and study processes. They wanted to have a dialogue on the most important and challenging parts of the protocol,” said Kasher at Eli Lilly.
Ongoing study management
While 48% of sites rated the average sponsor “excellent” in low monitor turnover, 21% said turnover has gotten worse during the past three years.
Novo Nordisk received among the highest scores at 55%. Historically, it has outsourced fewer than 2% of its studies. The average tenure for its monitors is 15 years, unusual for a job with high burnout rates across the industry. It credits low turnover to valuing its employees and addressing their concerns, recently moving to a regionalized monitoring model, by which monitors must live within 50 miles of patient hubs. About 95% of CRAs live within 100 miles of the hospitals they visit.
Amgen, which sources monitoring through an FSP model, reports a 16 % turnover rate for monitors globally, lower than the industry average of 25%. Amgen received among the highest scores for low monitor turnover at 46.2%, up from 33% in 2007.
Implementing practices to narrow the significant gaps between site expectations and sponsor performance will be critical moving forward. Top-ranked sponsors already have shown that listening to the frustrations expressed by investigators and implementing changes can help build strong sponsor-site relationships, which can lead to more predictable, higher-quality site performance.
Which companies would you rank as your top sponsors? Are these relationship attributes the ones you consider most important?