Managing Clinical Trials in Emerging Markets - Pharmaceutical Executive

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Managing Clinical Trials in Emerging Markets

Pharmaceutical Executive


Early Results and Lessons Learned

This FSP model provides Amgen with greater control and flexibility than is generally available using traditional CRO outsourcing. More importantly, the hub-and-spoke approach ensures efficient and timely regulatory approval of the clinical trial application for global trials in emerging markets, while ensuring patient safety and compliance. The model has only been deployed since late 2008, yet Amgen is already realizing clear and positive results:

Seamless support of large and small global clinical trials in new countries;

Average time savings of approximately two months in CTA submission and approval;

Close to 100 percent reliability of on-time adverse event submission and periodic report compliance; and

Improved capacity to bring on, manage, and roll off the highly skilled resources required to support clinical studies

Yet the functional hub-and-spoke model is not without risks and challenges. For example, this model should not be deployed in regions where a company has local infrastructure because doing so creates inefficiencies and overlapping responsibilities.

Accurately forecasting the level of work is another challenge. With the functional service model, budgeting and associated planning must be done using an activity metric (for example, the number of CTAs completed or interactions with health authorities) rather than the aggregate patient number used in the full-service model. An additional difficulty with a hub-and-spoke system is aligning regional clinical and commercial staff. Despite initial attempts at complete alignment, a region-by-region analysis revealed that some regions were better served by a staffing model where clinical and commercial staff were not co-located. The FSP model has been designed primarily to support Amgen's clinical trials. As Amgen is expanding its commercial and clinical footprint in emerging markets, hubs have been created in support of the clinical activities, which do not necessarily represent commercial hubs for Amgen.

The full-service model remains an option, but the functional-service model is maturing and can be beneficial for companies seeking to expand globally with minimal infrastructure investment. The new model offers more operational control and flexibility, is scalable to changing business needs, and allows for brand building in new markets. Critically, implementation has been achieved primarily by redefining job descriptions for existing managers, and the overall setup costs have been quickly amortized through cost savings and effective trials.

Romi Singh is Executive Director, Global Regulatory Affairs & Safety at Amgen. He can be reached at

Vitaly Glozman is Director in PRTM's global healthcare practice. He can be reached at


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