How Registries Can Close Peri-Approval Info Gaps Left By Clinical Trials

By Neal Mantick, senior director, PAREXEL

Clinical trials conducted for regulatory approval of new pharma, biotech, device, and diagnostic products frequently do not provide the market intelligence required for successful product launch, in-market brand management, and longterm product growth. Queries about the proper use of a new product, expectations of treatment response, key drivers of market uptake, and performance against competitors often begin before market approval. The answers to these questions require real-world data over a broad spectrum of patients and physician-prescribing patterns — data that well-controlled or randomized clinical trials cannot deliver. The information gaps that remain at the conclusion of a clinical trial handicap decision makers who must make early choices about clinical messaging based primarily on the product’s approved labeling. By comparison, real-world studies — including disease registries — can provide a sponsor’s medical affairs and marketing managers with an early warning system for possible threats, as well as insight into potential future research opportunities, as they map a product’s life cycle. These managers are increasingly recognizing registries as a flexible and cost-effective strategy for closing the information gaps left by clinical trials to obtain the data needed to support clinical and marketing strategies. Registries, when designed effectively and integrated with a sponsor’s market research activities, can provide a steady stream of new information suitable for external communication to physicians and other healthcare providers, private and public payers, and regulatory authorities. At the same time, registries, along with market research findings, can provide early and ongoing feedback on the effectiveness of clinical messaging and brand management strategies for a sponsor’s internal audience.

Become Recognized As A Leading Researcher
The activities surrounding the launch of a new registry, as well as descriptive statistics of early registry data, can help establish the sponsor as a leading researcher in a new disease indication. Initial demographic and disease status data collected as patients enroll in a registry can better define the broader, real-world patient population beyond that studied in the controlled clinical trial. This increased understanding of affected patients, with their wider range of demographic characteristics, disease severities, and comorbidities, helps enhance mapping of the natural course of the disease, as well as develop evidence-based guidelines for patient diagnosis and monitoring. Early data from the registry also can be effectively combined with market research findings to position a new product in a new or crowded market. Effective positioning tells physicians and patients how a sponsor’s product is unique and the value it offers the target market. Even with the limited amount of information that often results from a registry’s first year of operation, registry data and market research findings in the peri-approval time frame can help build a solid foundation for future clinical research and brand management.

A Registry Can Evolve To Keep Data Relevant
As the sponsor’s needs change, or as the needs of the medical and patient communities adjust to new clinical advances over time, a registry can also evolve to address these new challenges. Clear strategic direction and appropriate planning can ensure that the registry will keep pace with the clinical and commercial information required for successful in-market brand management, providing early warnings for the medical affairs and marketing management teams, and monitoring effective strategy adjustments. During the early phases of the registry, sponsors can begin defining why physicians are exhibiting certain prescribing behaviors based on analyses of the registry’s clinical data, rather than tracking uptake and market share only. As a result, current (as well as future) gaps between the expected market effect of a product’s labeling and clinical messaging and actual prescribing behavior can be identified and addressed sooner rather than later, thereby providing opportunities for course corrections to optimize a product’s success in a complex medical marketplace. Evolving a registry to continually produce data and other important market information requires a periodic strategic reassessment of the key registry design and operational elements, continually building on the base of registry data and market research findings already gathered. The overall goal of any registry program is to continually produce reports and other communications that keep the registry output fresh and relevant to the participating physicians and patients, thereby encouraging their continued engagement in the registry program.