The AVOCA group, founded in 1999, is a consulting and survey research firm based in Princeton, NJ. Each year, Avoca conducts industry research to measure current trends in clinical outsourcing and produces a report on the results. This year’s survey, recently published, concerned “Intelligent” Approaches to Clinical Development: an interesting insight into Sponsor – Clinical Research Organisation requirements, approaches and relationships with their general perceptions of outsourced clinical development and application of novel approaches to it.

“Intelligent” clinical development approaches are defined as those that make use of operational (e.g. performance) and/or clinical data, along with appropriate analytical techniques, in order to optimise aspects of clinical development such as protocol design, Investigator selection, patient recruitment approaches, resource allocation (e.g. risk-based monitoring), etc.

127 respondents from 83 pharmaceutical and clinical service provider companies participated in the research. These individuals reported on how “intelligent,” data-driven approaches are being utilized in outsourced clinical development today, from the perspective of both sponsor organisations as well as the service providers that support them.

Areas explored in this research include:

• Application of “Intelligent” Approaches
• Contributing Forces
• Satisfaction with “Intelligent” Approaches
• Engagement with CROs
• Change Management Initiatives

Summary findings from the survey are as follows:

Interestingly, respondents from Sponsor organisations generally reported lower levels of satisfaction than Providers in the respective areas evaluated. The difference in perceptions of quality has grown more pronounced, as satisfaction of Providers (44% “very satisfied” in 2014 vs. 27% in 2013) has increased much more than satisfaction of Sponsors (4% in 2014 vs. 2% in 2013).

• A greater proportion of respondents from Sponsor organisations perceive room for improvement in the efficiency with which outsourced projects are managed relative to Provider respondents. Nearly 30% of Sponsors surveyed said efficiency could be improved by more than 25%, while less than 10% of Providers reported the same.
• More than 60% of Sponsor respondents reported that they engage their CRO providers early in the process for most of the clinical trials they execute, whereas less than 40% of Provider respondents indicated that they are typically engaged early in the process.
• Both Sponsor and Provider respondents had mixed views regarding the frequency of collaboration on protocol design, but a much greater percentage of Providers than Sponsors reported believing that collaboration greatly improves the quality of protocol design.

Most respondents from Sponsor and Provider companies reported using “intelligent” approaches to region selection and site selection for a majority of trials they conduct, and close to half reported using these approaches for cost management and project management. Usage of “intelligent” approaches for other clinical trial activities varied.

• A greater proportion of Provider respondents reported making at least moderate advances over the past two years in each of the clinical trial activities evaluated than Sponsor respondents. The largest gaps were associated with region selection, data collection tools and monitoring.
• A majority of Sponsors surveyed indicated that Providers are making significant or essential contributions to the use of “intelligent” approaches in four key areas: site selection, region selection, monitoring, and patient/volunteer recruitment. Sponsors perceive the smallest contributions in the area of cost benchmarking/management.
• Providers were most likely to report that Sponsors are making significant or essential contributions to protocol procedures/eligibility criteria, overall protocol design and region selection. Looking across all areas evaluated, Provider perceptions of Sponsor contributions were less pronounced than Sponsor perceptions of Provider contributions.

A relatively large percentage of Providers acknowledged that Sponsors have contributed to their adoption of “intelligent” approaches to clinical development by helping them understand general approaches and by making data available. For Sponsors, contributions of Providers were primarily around technology and data availability.

• A slightly greater percentage of Provider than Sponsor respondents reported having implemented change management initiatives to accelerate the adoption of “intelligent” approaches to clinical development, and a much greater percentage of Providers reported using new technologies in that capacity.
• On average, Sponsor ratings of satisfaction with internal application of “intelligent” approaches was higher than satisfaction with Providers in nearly every area evaluated. Furthermore, a gap was observed across all areas with respect to how Sponsors view performance of Providers and how Providers assessed their own performance.

What messages can we take home from these findings?

• There remains a gap in perceptions among Sponsors and Providers in various areas, including overall quality that is being delivered, the impact of collaborating on protocol design, and satisfaction associated with the application of data-driven approaches to clinical development. Both parties could benefit from investing additional time at the beginning of a relationship (or at the program level) using a formal, structured approach to clarify roles and expectations, and to document in three areas:

╸How quality will be assessed and measured.

╸The extent to which Providers will have input on protocol design and other early program activities.

╸The tools and capabilities each party offers to support data-driven approaches to various program activities and how to optimize usage.

• While significant advancements have been made in the movement towards more “intelligent” approaches to clinical development, additional progress and consistency is needed to realize the full potential of these new approaches. Both Sponsors and Providers should develop tailored strategies to guide investment in this area with very clear priorities regarding capabilities needed in-house vs. those best fulfilled via relationships with external providers. Strategies must be designed to evolve with changing dynamics of the marketplace (technological, economic, regulatory etc.).

Clearly, it is important for Pharma, Biotech or Medtech companies looking to collaborate with a CRO to choose one with a good track record of delivering efficient, top quality timely results using effective and appropriate approaches with this, importantly, supported by testimonials to prove real satisfaction and repeat business.  Equally, Sponsors should genuinely engage with their CRO’s as early as possible in the trial process.

References:

The 2014 Avoca Report:  “Intelligent” Approaches to Clinical Development Executive Summary http://www2.theavocagroup.com/industry-survey