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The cost of pivotal clinical trials continues to rise as does the time required for completion. While the costs can vary considerably based on the number of subjects, trial length and endpoints, they are among the most expensive components of bringing a new drug candidate to market. Indeed, according to Nature Reviews, the median cost of a Phase III study is over $21 million.1
Our view is that market research early in the development process can significantly enhance and define the clinical program, so that the clinical program can most beneficially support not just the evaluation of safety and efficacy, but also all the other parameters such as claims and labeling that influence the success of a product in the marketplace.
There already exists a well-established framework for incorporating customer input to inform the commercial development process. While the road map may differs lightly by company and therapeutic category, it typically includes market research to understand the market landscape and the customer journey. It also includes target product profile testing, demand forecasting, product positioning, market segmentation and message development.
The real question is: Why don’t we use these tools earlier in the development process, especially as part of the design of clinical trials? Why are these tools and customer input designed only for the commercial team?Why don’t we incorporate these tools to reduce risk and maximize market potential by informing trial design and the clinical program?
One might argue that there is too much uncertainty at such an early stage to focus market research on customer perceptions and other non-clinical matters.How can we ask for input when we do not yet know what our product will look like? How can our customers tell us how they would behave in a market that may not yet exist?
We would argue that it is precisely because of this uncertainty that seeking to better understand how customers might react to our product in various scenarios is especially important in creating a successful development program.
Our view is that understanding which measures and outcomes in clinical trials and the clinical program will drive HCP adoption, patient interest and compliance, and payer reimbursement provide an enormous value.
Market research tools can be used to understand a variety of key clinical trial parameters including:
We conduct research to determine the importance of each design element in driving interest and ultimately market share for our product. For example, what is the relative value of the size of the trial versus the length of treatment during the trial? More importantly, we can determine the value of different levels of performance foreach component. For example, what is the value of measuring against active drug comparators versus placebo in driving interest and share?
Starting with Qualitative Research
We typically start with a phase of qualitative research that can be both exploratory and confirmatory depending upon the clinical team’s understanding of the current and future market. The main goal is to pressure test the assumptions of the clinical development team. Key questions this research should consider are:
Oftentimes we will begin with in-depth qualitative interviews with Key Opinion Leaders in an effort to understand how the market will change with expected treatments and which future product components are viewed as minimally acceptable vs. transformational.This is followed by interviews with HCPs and perhaps patients and payers depending upon the therapeutic category.
From there we work with the clinical development team to explore what they are contemplating for their trials, including primary and secondary endpoints, patient characteristics, and trial duration. Since this is often a lengthy list of parameters, we may also conduct a second, smaller phase of qualitative research to assure that the variables are clearly understood, determine which trial characteristics customers pay attention to and why, and the meaningful performance thresholds.
This allows us to pare down the variables we would want to include in the subsequent quantitative research phase.
To determine the value of various clinical trial parameters as well as the range of outcomes resulting from the clinical trial itself, we conduct quantitative research utilizing Choice Modeling methods. This involves survey research with a representative sample of prescribingHCPs. We incorporate experimental design techniques that enable us to understand physicians’ prescribing given any outcome from the clinical trials.
A key component of this stage lies in quantifying the product attributes that were previously uncovered as important in qualitative research and understanding their true potential impact on a new product. Understanding the sensitivity of these attributes across varying levels reflects the preferences and trade-offs that HCPs would make in real-world scenarios and allows us to prioritize endpoints and trial design.
The output from this research allows us to build market simulation models which identify the optimal elements that should be included in the Phase III trial design. It also allows us to run unlimited “what if” scenarios demonstrating the impact of each clinical design component and how various outcomes from the trial will drive market share while also having the benefit of helping with scenario planning. These results help the team understand and envision future market share by patient type and physician specialty.
By incorporating inputs from other customer groups such as patients or payers, we can build demand estimation models which link physician prescribing, patient interest and payer formulary placement to more accurately forecast future market acceptance. Most importantly, utilizing patient perspective to shape trial design ensures we remain grounded on bringing products to market that meet the real-world needs of patients and aid in the development of more patient-friendly trial protocols.
Nature Reviews reported that 4900 Phase III clinical trials were initiated in 2023.2 Millions of dollars are being spent on each one. Based on our experience, we strongly believe that, to inform and better design clinical trials and a sound clinical program, an investment of an additional$200,000 to $250,000 for market research is logical and valuable. This investment pales in comparison to the sunk costs of a failed clinical trial. In the Oncology sector, these costs are estimated of up to $60 billion each year.3
This relatively small investment will help ensure that the clinical program will lead to the approval of new products that will have a greater chance to maximize their market potential when launched.
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1. Martin, L., Hutchens, M., Hawkins, C. et al. How much do clinical trials cost?. Nat Rev Drug Discov 16, 381–382 (2017).https://doi.org/10.1038/nrd.2017.701.
2. https://www.nature.com/articles/d41573-024-00048-w#:~:text=Drug%20developers%20initiated%20nearly%204%2C900,Institute%20for%20Human%20Data%20Science2.
3. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2807710#xd_co_f=NzgzNDY4ZjAtNDU1Ny00YzYxLWIwY2ItYTZiNWRlNjRlYjIz~
