Major medical device makers are expecting more clinical trials as they expand into emerging markets and have common strategies and expectations around the contract research organizations [CROs] they work with. For companies to expand into these markets, they must conduct clinical trials both to ensure device safety and efficacy and also to comply with local regulatory guidelines. The solution for many manufacturers has been to expand and open small branches or even large-scale research facilities within emerging markets. Others outsource to contract CROs.
|Companies survyed reported data management was the most outsourced service. [image via Best Practices LLC]
Best Practices LLC, a benchmarking research and management consulting firm, conducted a survey of major device makers that yielded some trends and insights into the considerations device manufacturers make when working with clinical research associates (CRAs).
In the study, Clinical Affairs Excellence: Benchmarking Clinical Trial Strategies to Ensure Medical Device Success in a Global Marketplace, Best Practices surveyed 13 “clinical leaders” and 10 medical device organizations, including representatives from Medtronic, St. Jude Medical, Stryker, Boston Scientific, and Teleflex, with four key objectives in mind:
? Determine the regions where medical device organizations conduct clinical trials and percent of patients recruited annually from each region.
? Identify which clinical affairs activities are best suited to be outsourced or kept in- house.
? Gauge what the experience of peer device organizations has been relative to the cost of outsourcing clinical trial activities.
? Rate the value of benefits associated with outsourcing clinical trial activities
The companies surveyed reported that 91% of their clinical trial patients, on average, are based in the United States and Europe. But they reported that an average of 6% of their patients were in Asia-Pacific and 2% were in emerging markets. However, a majority of clinical leaders in the device segment (64%) believe more trials will be conducted in Asia-Pacific and emerging markets in the coming years.
On average, participants described their clinical trial staffing mix as 72% in-house, 22% outsourced, and 4% offshore. Best Practices predicts that “as cost pressures escalate and regulators in other countries require more local trials, offshore and outsourced staffing will increase at device firms, while in-house staff will shrink.”
Among key activities, data management was the most outsourced by companies surveyed (40%). Other prominent areas included site management (29%) and data analysis (27%). Very few outsourced their investor recruitment, with 97% reporting that it is handled in-house.
When working with an outsourcing vendor, device leaders cited a track record with the target geography and in a particular therapeutic area as being the best predictors for quality. Best Practices says companies also cited the vendor’s turnover rate as a measure of quality. Interpersonal skills for internal and external interactions, and a detail-oriented personality also high on the list of sought after qualities for CRAs.
In the coming two to three years, most medical device clinical leaders report that they expect to see an increase in trials in high-growth, emerging areas of the world. To handle that growth, they anticipate hiring more outsource and offshore staff (company employees located in low-cost regions). Seventy-seven percent expect an increase in the number of clinical trials in emerging and high-growth markets as well as an increase in outsourced staffing. Another 69% expect an increase in offshore staffing. Every company (100%) expected the number of clinical trails to support Class III and Class II products and nondisclosure agreements to increase.
On average, the device companies surveyed for the report had $3.8 billion in annual revenue and a clinical affairs group with a $39 million budget.