Approximately 25% of late phase trials fail due to commercial and strategic issues. A more robustly developed Target Product Profile (TPP) could reduce this risk and result in a stronger business case, forecast and basis for clinical trial design decisions. Here, we argue that combining real-world data (RWD) with primary market research (PMR) delivers more granular and robust insights for development of next generation TPPs.
A TPP is a critical strategic planning tool in clinical and commercial development. It is even more critical and challenging to develop an effective TPP in therapeutic areas where the product will drive a change in behaviours (e.g. current treatment options are poor or non-existent) or in a rare disease. It is almost impossible for clinicians to predict how their behaviours will change when the current norms of clinical practice have been altered. We need to overcome the inherent methodological limitations of clinician-only approach.
The next generation TPP informed by such rich and robust insight foundation from RWD and PMR is not only better equipped to support internal decision making and forecasts, but also hold up to the increasing scrutiny by healthcare stakeholders and address their demand for demonstrating differential value.
- RWD and PMR provide complementary narratives: RWD bring objectivity – what is really happening in the healthcare system – while PMR offers insight into the rationale underlying HCP or payer behaviours (‘why?’) and their future projected behaviour.
- RWD enhance the quality and value of the insight generated via PMR: guided by RWD, primary research with HCPs, and payers, can be much more targeted and thorough when testing pre-defined hypotheses or scenarios.
- RWD provide a reality check, ensuring target patient cohorts are clinically meaningful, i.e. they exist in the real world, can be identified and targeted, which can then be validated and enhanced through discussions with clinicians.
- Where HCP recall fundamentally cannot yield meaningful answers, e.g. in diseases with multiple, poorly defined patient sub-populations, a high number of un-/mis-diagnosed patients, with complex patient pathways crossing specialties and care settings, or in the absence of existing treatment options. Only RWD can provide a robust fact base to pinpoint opportunities and quantify unmet needs.
In an increasingly complex, uncertain and demanding environment, real-word data have an essential role to play in developing the next generation TPP. When combined synergistically with PMR, RWD can create a deeper, more granular and more robust insight foundation. This foundation is a critical enabler for informing a TPP that reflects the increasing scrutiny by healthcare stakeholders and addresses their demand for demonstrating differential value.
However, for RWD to be utilised in an optimal way, the distinctive characteristics of RWD need to be well understood, and a thoughtful, pragmatic approach should be followed which balances benefits, cost and timelines.
Pharmaceutical companies should embrace the uniquely powerful combination of RWD and PMR to enable the next generation TPP, thereby setting themselves up for greater success in development and commercialisation.
Download our full analysis for next generation TPPs here.
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