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Why strategy is the cornerstone of success: Clearly establishing a registry's strategic purpose can save both time and money, eliminating the collection of extraneous data as well as the added burden it spawns.
Pharmaceutical, biotech, and medical device companies are increasingly turning to patient registries and other prospective, observational research initiatives as a vehicle for capturing vital real world data to document postapproval safety, to substantiate economic value, and/or to explore patient quality-of-life. The goals of a registry can be multifaceted, but these fundamental objectives are often overlooked or minimized when a program is conceptualized and designed.
Matthew J. Gordon
As a result, registries can run the risk of being over-engineered—employing the operational structure of a more traditional, controlled clinical trial when a streamlined approach may be better suited for the underlying strategic goals.
A registry should be seen as the primary vehicle for collecting long-term, observational data (usually from a large cohort of patients) to better understand the natural history, management, and outcomes of patients with a particular disease and/or employing a particular treatment regimen. Registries also provide a framework to address many of the questions that have not been and cannot be answered through controlled clinical research—questions regarding treatment selection and usage by physicians; best practices in a real-world setting in which diagnostic and treatment approaches vary considerably; and even the long-term treatment effects on clinical, safety, economic, and humanistic outcomes under actual medical practice conditions.
However, to get the best results from any registry, a fundamental first step is defining what "success" really means.
When charged with the responsibility of designing and implementing a registry or, for that matter, any prospective research program, the tendency is to immediately consider what data is to be collected and the manner in which it will be compiled. Successful registries, however, are characterized by these considerations being intermediate steps, following strategic and analytical definitions and preceding other operational components supporting data, site management, and quality control. If improperly sequenced, the registry will likely seek to capture more data than necessary, unnecessarily burdening the program and its participants.
The initial step is to establish the primary purpose for the registry, such as responding to a regulatory mandate for postapproval safety data or demonstrating the real-world value of a new treatment alternative. The operational implication for these two typical yet divergent strategic statements are far-reaching, impacting everything from analytical planning to site selection to program scope and duration to data management. Moreover, the definition of "success" inherent in these two statements is intrinsically different, the former implying a much more tangible outcome than the latter.
The data to be collected must be built on analytical plans, which in turn are built on the cornerstone of strategy. Only then can data management approaches, data quality assurance procedures, and site support activities be truly informed.
Registries are often conceptualized through contributions from stakeholders representing multifunctional groups incorporating perspectives as diverse as product marketing and sales, legal and regulatory compliance, pharmacovigilance, and finance. Hence, it's critical to gain internal consensus and establish consistent expectations among all registry stakeholders, who must each recognize that the registry is typically a careful blending of often variant frames of reference.
Again, clearly stating the registry's strategic purpose can be the most important step in achieving operational consensus and in designing an efficient and cost-effective research initiative.
In a storm, a house is only as strong as its foundation. Similarly, the often unstable environment surrounding a patient registry can cause it considerable damage without the benefits of a solid and strategic cornerstone.
Matthew J. Gordon Associate Director, Registry Consulting, ICON Clinical Research–Lifecycle Sciences Group.