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AAHC Report: Clinical Trials Offices Need Models, Standardization

Monday, September 14, 2009

Clinical trials offices (CTOs) have sprung up in academic health centers across the country, but the roles these offices serve vary widely from center to center, according to a new report.

“Clinical Trial Offices: What’s New in Research Administration?” was released earlier this month by the Association of Academic Health Centers (AAHC), a non-profit organization focused on academic health centers in the United States. The report showed that the trend toward consolidating or centralizing clinical trial functions in academic health centers is ongoing but still needs work, especially in terms of standardization.

“You have to recognize that in a university environment, you’re not going to get a lot of cookie-cutter approaches, and everyone has to deal with the structures they have and the size and the resources and the rest … But we were still surprised at seeing the lack of uniformity out there,” said study co-author and AAHC vice president for policy and program Elaine Rubin, Ph.D.

Rubin and her co-author Danielle Lazar, AAHC program associate, based the report on interviews with leaders at eight academic health centers, including six institutions with CTOs and two without. Of the eight profiled centers, four were public universities and four were private. There are about 130 AHCs in the U.S.

The authors looked at the centers’ CTO development, responsibilities, organization, structure, leadership involvement and future plans.

“We were surprised to see two sort of parallel infrastructures working together—what could also maybe be seen as the old and the new,” Rubin said. “I think it’s showing that the institutions are still in transition, and they’re working with the culture that they have and the resources that they have.”

According to a 2007-2008 survey of 61 AAHC members, 63.9% had a CTO. CTOs began cropping up in academic health centers more than 10 years ago as a way for institutions to become more efficient by consolidating clinical research administrative activities, such as billing, contracting, protocol development and compliance.

While CTOs have achieved the goal of making clinical trial administration more centralized, Rubin said, clinical trial operations are oftentimes still spread out across the organizations and their duties vary. According to AAHC’s findings, many CTOs handle some, but not all, of the work associated with clinical trial management, and, in some instances, the CTOs don’t serve all of the institutions’ researchers. Rather, they operate in parallel to other clinical trial–related offices and infrastructure, defeating the purpose of having a centralized CTO.

“In one sense, I want to be able to say to you that this is truly becoming a management center—a one-stop-shop consolidation for scientific review, budgeting, contracting, compliance, education and training. On the other hand, I see some offices that are so focused, let’s say, on education and training or on budgeting, that they’re not one-stop shops. I think what we’re going to see is that they really will become more one-stop shops,” Rubin said.

AAHC plans to follow up on this report in the future and perhaps provide more detail on what should be included in standardized CTO models.

At the very least, the AAHC recommends that academic health centers look at their CTOs to determine if they serve the following four functions:  a focal point for all billing and compliance activities, increased communication and coordination of activities and policies, consolidated education and training, decreased redundancy and costs for staffing and infrastructure, and increased access to information for university and academic health center leadership.

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