Economics in Clinical Trials: A Guide to Value-Based Decisions

By Danélia Botes

April 21, 2024


The inclusion of economic analysis in clinical trials has burgeoned into a cornerstone of modern healthcare decision-making. This approach not only elucidates the cost-effectiveness of medical interventions but also aids in shaping policies that align with value-based healthcare principles. As healthcare systems globally pivot towards value-based models, understanding the intersection of economics and clinical outcomes becomes ever more crucial.

The Value of Economic Endpoints

Clinical trials, particularly randomised controlled trials (RCTs), are pivotal in establishing the efficacy of new treatments. However, understanding the economic implications of these interventions is equally essential. By integrating economic endpoints, researchers can determine whether the additional costs of a new treatment are justified by the benefits it offers.

Trial Design and Economic Analysis

Designing a clinical trial is crucial for a strong economic analysis. We need to think about the analysis perspective, time horizon, and economic analysis type. These strategic choices affect operational aspects like data measurement and cost estimation methods. This ensures we tailor the economic evaluation to the trial’s goals.

Types of Economic Analysis

Several forms of economic analysis can be incorporated into clinical trials, including cost-effectiveness analysis (CEA), cost analysis, and budget impact analysis. The choice of analysis type hinges on the specific questions the trial aims to answer and the broader impact of the intervention on the healthcare system.

Conditional Economic Analysis

Occasionally, the necessity for economic analysis is contingent upon the trial’s outcomes. It’s beneficial to incorporate economic expertise into the design phase of the trial. This ensures the collection of relevant data. If warranted, this data allows for a later economic evaluation.

The Role of Economic Analysis in Trial Design

The meticulous design of economic evaluations is often shaped by the trial’s focus and intricacies. For instance, in the Rheumatoid Arthritis Comparisons of Active Therapies (RACAT) trial, the economic analysis was paramount in assessing whether the substantial additional cost of biologic therapies was justified, given their effectiveness compared to lower-cost alternatives.


Economic analysis alongside clinical trials offers a nuanced lens through which the value of medical interventions can be assessed. Therefore, as we progress towards a healthcare landscape that prizes value-based care, such analyses are not just beneficial—they are essential for informed decision-making.

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