RG+A’s client needed to make a go/no-go decision for a Phase III clinical trial for a novel ADHD medication. It was unknown whether or not the product would get either an adult or adult and pediatric indication. Additionally, this company needed to know who would be most likely to use this product and what uptake and peak share might be given various scenarios of the product’s final attributes. RG+A used a combination of DPS® and QTM® methodologies to deliver answers to all of these major research questions along with a recommendation about how to proceed with the Phase III clinical trial. RG+A identified differences in adult compared to adult and pediatric indications, which physicians and patients were mostly likely to adopt this therapy, as well how variations in product attributes would impact uptake and peak share.
RG+A’s client, a mid-market global pharmaceutical company, was seeking to evaluate an ADHD product in order to make a go/no-go decision for a Phase III clinical trial. The client needed to know the impact of pursuing an adult-only indication versus an adult and pediatric indication. In addition, the client sought to identify segments of physicians, patients, and caregivers most likely to accept the new product. Lastly, potential share and impact of varying product features on uptake and peak share needed to be estimated.
RG+A used a two-phase approach that combined RG+A’s Dynamic Practice Simulation® (DPS) methodology as well as our Qualitative-to-Modeling® (QTM) approach to answer these complex research question.
In the DPS phase, 280 physicians treated 18 simulated patients (5040 total treatment events) administered through an online survey to estimate share for three different scenarios: the new product with just an adult indication, the product with an adult and pediatric indication, and the performance of the product two years after the combined adult and pediatric indication. In order to determine the impact of varying product features among physicians, the online survey also included a conjoint exercise.
The QTM phase was conducted among 20 patients and 21 caregivers and focused on identifying the patients and caregivers most likely to accept the new product. Similar to the DPS phase, the QTM phase also included a conjoint exercise to identify the impact of varying product features and to inform the minimally acceptable design of the product profile for patients and caregivers.
- Understand opportunity in both adult and pediatric populations to inform Phase III go/no-go decision
- Determine which physicians are most likely to prescribe and which patients/caregivers are most likely to accept new product
- Understand to what extent individual product features differentially resonate with physicians and patients
- Estimate uptake and peak share at a macro level incorporating all learnings from both phases of research
How the Design Addressed the Challenges
- DPS methodology assessed share in scenarios where the product received only an adult indication, both an adult and pediatric indication, and 2 years following the approval of the product for adult and pediatric populations
- The conjoint portion of the QTM and DPS phases of research assessed how varying product features impact patient/caregiver acceptance (QTM) and physician likelihood to prescribe (DPS) as well as the minimally acceptable product profile designs for both populations
- Results from both the QTM and DPS phases of research help identify which physicians are most likely to prescribe and which patients and caregivers are likely to accept the new product
The key data points from both phases of research were used as part of a Monte Carlo model to create uptake and peak share estimates. The final model was able to generate share estimates based on physician likelihood to prescribe the new product, patient and caregiver likelihood to accept the physician’s recommendation, and varying individual product features.
RG+A was able to deliver specific feedback to the client on the share impact of the adult compared with the adult and pediatric indication, as well as the uptake impact of specific product features among both physicians and patients/caregivers.
Based on the results of the model, RG+A recommended moving ahead with Phase III clinical trials. The client was satisfied with the uptake and peak share estimates that RG+A produced given their most likely and other potential launch scenarios.
This client continues to move forward with the Phase III clinical trial for their product. Following this project, they have a much clearer picture of how the final endpoints of their clinical trial and FDA indication will impact the uptake and peak share of their product. This means that they can begin training their salesforce prior to launch so that they can be as prepared as possible for any potential barriers to use from both physicians and patients/caregivers.