Using Allocation Exercises to Inform Clinical Trial Design
Clinical trials are a significant portion of the cost to bring a new drug to market. Recent research published in Clinical Trials estimated the combined average total cost of conducting a single endocrinology clinical trial in each of Phases I, II, and III was US $30.5 million (Sertkaya, Wong, Jessup, and Beleche 2016). With costs this high (and likely higher as time goes on), it’s natural to wonder if there are ways to optimize a clinical trial’s impact before committing to the substantial investment required. Fortunately, market research provides two opportunities to gauge the impact of a clinical trial through use of two designed experiment methodologies.
The first is a novel application of patient allocations: Clinical Trial Allocations or CTA. CTA is a designed experiment that uses clinicians’ prescribing habits for current market offerings to create a baseline, which we compare to several post-product profile allocations (“post allocations”) to estimate the impact of various clinical trial scenarios and drug configurations. Depending on the needs of the research, these post allocations can include a single new market entrant, multiple independent market entrants, or even multiple market entrants intended as combination therapies. Before each post allocation scenario, we prime clinicians with a new product profile to layer in the different entrants of interest. Beyond market entrance scenarios, we implement a further round of post allocations to test various clinical trial scenarios. Each clinical trial scenario can cover the trial’s design overview, the study arms and timeline, as well as expected results from the trial. Changes in clinicians’ patient allocations after reviewing the clinical trial scenario allows researchers to generate an estimate of the trial’s impact on prescribing that is independent of the drug’s product profile. Conducting CTA with multiple trial scenarios allows researchers to prioritize which clinical trial will have the most impact, enabling pharmaceutical companies to use cost-benefit analysis to inform their decision of which trials to conduct. In one CTA study we conducted, we analyzed the introduction of two competing Type 2 diabetes drugs entering the market with a suite of five clinical trial scenarios. We confirmed that endocrinologists would be more likely early adopters than primary care physicians, and that they were more engaged and receptive to the clinical trial results. The results of that CTA study also helped our client avoid a costly mistake by identifying that one of the proposed clinical trials would actually hurt their drug’s perceptions in the market.
The second is an application of choice-based conjoint to clinical trials called Clinical Trial Conjoint (CTC). Choice-based conjoint is a designed experiment that uses varying attributes across multiple product profiles to simulate market decision-making. By showing profiles with multiple attributes that vary independently, we require respondents to make decisions where tradeoffs are inevitable, which allows us to estimate the independent impact of each variation of each attribute on respondents’ preferences. When used with clinicians, the exercise has respondents allocate patients across each scenario, simulating their prescribing decisions for the relevant patient population. We can adapt this versatile experiment to inform clinical trial design in two main ways.
If the drug intended for clinical trials is still undergoing early research and development, then the product profiles of the CTC are built to match the drug and its potential competitors. Including one or more attributes that describe clinical trials and/or their results allow us to quantify the impacts of those trials and/or results.
If the drug is further along in the development process, then the drug is presented as a fixed product profile displayed before the CTC. This approach allows each conjoint profile in each scenario to be a separate clinical trial composed of attributes that vary the aspects of the trial itself (study arms, endpoints, timeline, results, etc.). Having the profiles focus on the clinical trials while asking clinicians to pick the most persuasive study enables us to help pharmaceutical companies optimize the attributes of their clinical trial to maximize its impact on clinician’s prescribing patterns.
Both Clinical Trial Allocations and Clinical Trial Conjoints are powerful tools to help companies gauge the potential market impact of their clinical trials so they can make the best use of their limited resources; we can use them in tandem for even greater effect. KJT Group has been conducting studies utilizing these methodologies for more than six years and is always willing to help you maximize the potential benefits of your clinical trials with supplementary market research.
Source: Sertkaya A, Wong HH, Jessup A, Beleche T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin Trials. 2016;13(2):117–126. [PubMed]