MediciGlobal

TPS programs are based on the power of information and how to use information strategically to optimize sales and accelerate the clinical research process. Accelerating the time to peak sales requires marketing and clinical teamwork. Achieving that objective requires incorporating information into the clinical protocol; strategic planning that focuses on physicians’ prescribing patterns, products used, and dose ranges in specific patient populations by disease severity; and data that profile patients and their use of healthcare services. Those data should include consideration of comorbid conditions, concomitant therapies, physician specialties, and when and where patients access healthcare. In sum, understanding the various aspects of real-world market dynamics benefits everyone in understanding the process.

For many years, marketing has used health services data and supporting information to guide its strategies for both marketed and launch-phase products. Rarely though has such data been introduced earlier in a product’s life cycle—namely, the clinical trial phase.

Traditionally we think about understanding the market nuances of a particular therapeutic area in the prelaunch phase of a product. But what does it mean to incorporate certain specific therapeutic data about patients and the physicians who treat them even earlier in the strategic-planning stage of a product’s life cycle? Can optimal marketing success be achieved by integrating marketing as well as research and development objectives into the product development process using key market data? Can TPS be shortened? The answer is yes.

KEEPING IT EVERGREEN

The concept of keeping products evergreen—producing a viable revenue stream—requires marketing and clinical teams to strategically use data that profile the use of services and pharmaceuticals within each therapeutic category. That allows companies to identify new product-line extensions and new indications and to design clinical studies of new products that fill a market niche or specifically offer added value to existing patient care.
TPS acceleration is built on the premise that critical market information applied properly can guide the clinical team in developing realistic protocols. The approach involves a targeted process for selecting clinical research sites and determining patient recruitment and enrollment goals to accelerate time to market. For marketed products, companies can expand market share and subsequently achieve peak sales by identifying and filling market gaps by way of comprehensive health management studies across many therapeutic areas.

PATIENT RETENTION AND COMPLIANCE

All too often, disease management programs focus on treating only one disease. But health management data show that populations with chronic illnesses such as depression have a heavier burden of illness and encounter more physician specialists than other patients do. Those factors can affect treatment outcome, lead to potential adverse events, and affect whether patients remain compliant on their therapy or whether they remain in a clinical trial. Such factors help shape the patient issues that companies must consider in developing a patient retention program.

For both long-term chronic disease therapies and for clinical studies, disease or retention management programs play important roles in patient compliance and in keeping patients interested in clinical trial participation until study conclusion. Incorporating disease management strategies into marketing and clinical research is a key part of establishing sound clinical support for products earlier in their evolution. For example, a patient who recently started on an antidepressant treatment might not continue the study medication if it takes several weeks for the treatment to take effect. Contacting the patient, encouraging compliance, and reeducating the patient that symptomatic improvement may not be seen for three to six weeks are critical, especially if a study has a washout period.

Clinical research teams must consider what the market data show about current prescribing patterns, comorbid conditions, clinical and economic outcomes, and other issues of interest to future customers for their efforts to be consistent with TPS. The impact of a new treatment on such key factors and the cost are parameters that often extend beyond the traditional focus of clinical research. Considering additional market parameters early in the clinical research phase provides marketing with needed data for new and existing products to maximize TPS.

For example, a clinical trial that tested a new treatment for depression excluded from participation those patients with additional chronic medical conditions. When the health management report showed the significant burden of illness experienced by such patients, the protocol was amended to include patients having other conditions.

Failure to do so would have resulted in a study that was not grounded in the reality of medical practice, enrollment would have been negatively affected, and marketing efforts for accelerating the TPS would have been negated.

WHEN SHOULD YOU PLAN?

Clinical research teams can learn a lot from their marketing colleagues when it comes to using healthcare data to drive decisions. Understanding how market data can direct clinical decisions and become an integral part of clinical trial planning requires that researchers recognize how marketing techniques are necessary for successful study implementation. TPS is one of those factors, but for clinical research there are others as well, such as:

• more competition for fewer research patients;
• more complex clinical protocols, with more procedures;
• making difficult decisions on which research sites to support and which ones to “let go” based on performance, such as success in recruiting patients, and;
• transferring meaningful market data and knowledge obtained during the clinical marketing process to assist with the product launch.

To accelerate TPS, outcomes data must be based on a study design that strikes a balance between scientific soundness and a basis in real-life clinical medicine. Reviewing and incorporating key data into the design of outcomes studies may sound complex, but making such studies relevant to geographic and institutional prescribing differences is critical.

Specific healthcare databases developed by specialized health data companies can tell you the medical specialties predominantly treating the patients you seek and in what settings (hospital, community-based, or university-based) the patients are receiving their treatment, as was seen in the depression study referenced earlier. Healthcare data that profile how episodes of illness are treated and managed can help marketing teams define the best product positioning, and identify early the marketing hurdles that must be overcome with critical data and information. That information must be factored into the design of clinical studies from the outset, often five years in advance of FDA submission.

THE EARLIER THE BETTER

It is vital that companies incorporate certain episode-of-care data early in the study design phase. That data should break out the costs related to treatment visits, tests, procedures, inpatient admissions, noninpatient facility use, and other costs to ensure that market-driven clinical studies deliver real-life and not hypothetical cost-benefit and outcomes data. That is precisely the type of data managed-care and other healthcare customers seek. It removes ambiguity about where certain patients are treated and by whom, which can change depending on the stage of the illness, such as in depression and cancer.

Bridging the gap between marketing and clinical research early in the product life cycle is critical to the ways a product is subsequently marketed and supported by relevant-marketbased clinical data. That is a critical part of the achieving-TPS equation.

ACCELERATING TPS

The shift in management focus from time to market toward TPS is not just an adage nor an unattainable goal. Achieving that vision, however, requires support and a partnership between marketing and clinical research — not an easy feat when the language and culture of the two disciplines have been so different.

TPS can be achieved only by rewarding the key stakeholders and demonstrating the ways critical health services data can benefit a product in the research or marketing phase. Health management data can have the greatest impact on acceleration of TPS when three things come together: marketing, research leadership, and companies that not only provide critical market data but also truly demonstrate how to use key data to drive decisions, develop strategies, and maximize performance and success. The power of information can be unleashed only when that power is appropriately applied.

BioExecutive International