Maximizing post-marketing research for robust return on investment

Today, more than ever before, biopharma companies are coming under pressure to demonstrate the value of their products in meaningful terms to varied stakeholders and audiences. The need to build product evidence no longer ends at marketing approval; pharma companies still have more questions to answer and stakeholders to persuade of their product’s real-world therapeutic benefit, safety and effectiveness. With these growing demands for data and shrinking revenue streams, the pressure to make the most of any post-marketing research investments has never been greater.

In designing post-marketing studies, a key consideration for sponsors must be how to achieve multiple objectives while keeping costs balanced and still maximizing the value of the study. Designing post-marketing studies proactively to achieve these goals is essential. One effective approach is to start small and plan to scale up in size, scope and length of the study.

By taking this flexible approach, sponsors can meet multiple data needs, including publishing findings for abstracts and conference presentations throughout a study. This can significantly increase the return on their research investment, while minimizing risk, and ultimately help the product reach its true potential for the company and patients alike.

Case Study: Scalability Optimizes Largest Observational Diabetes Study (* see below for study details)

When our customer set out to explore ways to differentiate their diabetes product in a crowded marketplace through post-marketing research, they didn't know how successful or large the study would be. To guard against unnecessary investment risk, the customer planned to start the study small and scale up as the data indicated market potential. They needed an ally with the experience and knowledge to  plan for the unknown and the expertise to design a study that could eventually include multiple affiliates and thousands of sites, with start-ups staggered over time.

Combining post-marketing experience and operational ingenuity, Quintiles helped design a study that grew quickly and efficiently despite its logistical complexity. Through strategic planning and flawless execution, we delivered quality data, balanced costs and helped our customer achieve their marketing objectives.

Beginning with the End in Mind

Before the study began, Quintiles helped the customer develop the optimal operational designs, emphasizing streamlined processes and timely data validation. Knowing the interim analyses were vital to demonstrating the product's value, we brought in our biostatisticians with expertise in methods to produce valid data from post-marketing studies.

Also, to manage the logistics of preparing data from different sites and countries - each at a different stage of the study - we projected how many case report forms we would need, then planned how we would acquire that number before the scheduled analyses.

Our foresight allowed our customer to publish compelling, evidence-based findings for abstracts and conference presentations throughout the study, maximizing the study's value.

Delivering Value

Scalability Optimizes Largest Observational Diabetes Study

By putting the right resources in place across our global network, we were able to scale up the study when results warranted expansion. With proactive process checks and local communication channels, we maintained data quality while achieving cost effectiveness, even as we added countries mid-study.

Our customer's affiliates also had their own local marketing goals and objectives, which we supported by providing country-specific data for their marketing activities, including expert panel meetings and symposia. Some of the keys to working with the affiliates were: excellent communication on a local level, streamlined processes and an understanding of their specific needs.

Delivering Credible Data for Market Success

By successfully steering the largest post-marketing diabetes study ever conducted, we demonstrated our agility and precision to efficiently carry out an evolving global observational study and meet our customer's needs.

With proactive planning and our team's depth of experience, we were able to coordinate milestones to meet the deadlines for each interim analysis. Implementing efficiency and outcomes-focused strategies from the start allowed us to stay flexible and successfully scale up to an eight-country study with more than 55,000 patients, even with the operational challenges of multiple affiliates and staggered database locks.

As a result, our customer was able to provide real-world evidence that differentiated the product for payers and prescribers - and enhanced the product's commercial success.

Therapeutic, operational and market insight

Of course, understanding the issues around a product's therapeutic area can mean the difference between a product barely getting noticed or becoming a breakout success. For example, in diabetes, an endocrinologist has different wants and needs for therapeutics for their patients than an internist does. In designing a study it is helpful to understand these nuances between specialists and generalists - to know what resonates with prescribers.

Good relationships and mutual understanding is also helpful and at Quintiles we work to streamline operations and relations with our customers across the entire life-cycle. That means that the relevant knowledge from earlier phase study start-up, patient recruitment, retention, reporting and invoicing can be leveraged to create a streamlined, efficient project management plan for late phase.

This becomes critical when considering market access, the increasing number of stakeholders, and their differing requirements. It is important to coordinate late phase research effort with clinical trials to ensure that stakeholder needs as well as the required evidence is developed. In doing so, the risk-benefit profile of products is optimized and potential for commercial success is maximized.

Post-marketing research is a different playing field. In non-registration research there is no need to over-engineer a study. To drive productivity, sponsors need to find the right ally, who has the experience and understanding to apply the appropriate levels of monitoring and the right analysis techniques and sources.

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* Study Details

Objective: Generate data to demonstrate the safetyand effectiveness of a marketed product
Product: A biphasic insulin aspart
Indication: Type 2 diabetes
Design: Phase IV, multi-center observational study
Sites: 5,486 in Canada, China, Greece, India, Italy, Japan, Poland and Russia
Patients: 55,514
Recruitment Timeline: 6 months