Amgen Striving for All Electronic Data Capture

Amgen is trying to achieve 100 percent use of electronic data capture (EDC) in its clinical trials by the end of 2007, although the business case is not as strong as initially expected, according to clinical data management manager Kevin Reidy.

EDC's cost savings, while impressive, "won't be as fast we thought," Reidy said March 14 at a conference sponsored by the Center for Business Intelligence in Philadelphia. The company first began using EDC in some clinical trials in 2001, and now uses it in about 35 percent of its trials.

Amgen is focusing more on the long-term financial and time savings EDC delivers, he said. Part of that effort will receive additional focus in the second quarter when the company conducts a reassessment of its EDC return on investment (ROI) goals and metrics. It will then compare what it expected and hoped for in the first half of 2005 with where it is at today, Reidy said.

Starts at the Top

Stressing the importance of executive buy-in and a strong project manager at the helm, Reidy also said EDC projects have a much better shot at success if there are clear lines of responsibility. Amgen reinforced this by changing its procedures on document signoff. Under the old system, six or seven people often signed a document, but under the EDC program, only two people have to sign most documents. This makes it clearer who has responsibility for approval and clearance of an action, Reidy said.

Amgen broke up roles among six key people:

Study owner: Develops the study plan, manages study resources, tracks study metrics, manages tasks to ensure milestones are achieved and resolves studywide issues; Site owner: Conducts nontechnical site evaluations and source data verification, monitors site performance, participates in site initiation and training, supports site in non-date-related activities including protocol support, regulatory management and safety support; Data owner: Manages individual site data, conducts protocol-wide data quality analyses, generates data queries, tracks and manages query resolution, and prepares for initial and final data lock; eCRF Designer: Participates in development of study specifications, develops eCRF, develops edit checks and manages eCRF testing and publishing; System owner: Conducts technical site evaluations, system setup and technical training, and provides ongoing EDC technical support and issue resolution; and Edit check programmer: Develops edit checks that require programming outside of the EDC system and runs complex edit checks.

Part 11 Important Indicator

Reidy said that when Amgen was searching for an EDC vendor, it weeded out many candidates by focusing on the need to meet 21 CFR Part 11 requirements and prove financial stability. The latter is a "big one," he noted, because this is not yet a mature industry. If a company selects an EDC vendor that goes out of business or limps along financially, it makes life much tougher, he noted.

Ironically, EDC success can sometimes slow further expansion, Reidy warned. "Amgen must avoid the urge to 'proclaim victory' and move on to the next initiative," he said. Instead, the company is stressing that EDC is a multiyear effort.

Amgen will use the rest of 2006 to significantly expand its expertise in EDC, Reidy said. Third-quarter goals include having all early development studies conducted with EDC and initiating the company's first "mega" study involving over 200 sites. Amgen plans to roll out EDC in Japan during the final quarter of 2006, he added. -- Michael Causey