Health Economics & Outcomes Research Health Resource Data Collection within Clinical Trials

Health Resource Data Collection within Clinical Trials

The collection of health resource utilization data within randomized controlled trials (RCTs) has both strengths and weaknesses for use in economic evaluations. Economic data can be collected within either an existing randomized clinical trial or through a Phase IV trial specifically designed for the purpose of economic evaluation and determination of best clinical practice.

Randomized Clinical Trials (RCTs) 

Often considered the de facto gold standard for assessing safety and efficacy, it has become common practice to collect health resource utilization data within existing RCTs. Strengths of this approach include:

  • The prospective collection of health resource utilization data while utilizing the existing RCT infrastructure
    • Consequently requiring minimal incremental resource investment.

Challenges also inherent to this approach include:

  • Limited ability of RCTs, primarily designed for clinical purposes, to answer economic questions, because of :
    • The use of surrogate clinical endpoints as proxies for treatment effectiveness 
    • lack of long term follow up
  • Placebo-controlled trials unrepresentative of usual clinical practice.

William Irish, MSc, PhD
Vice President, Biostatistics & Health Outcomes Research
Dr. Irish has over 30 years of academic and industry experience, including experience in planning, studying and reporting on health outcomes research, most notably in multi-site clinical trials, epidemiologic, and large database studies in transplantation. His vast knowledge in biometrics, as well as his extensive therapeutic experience, make him an asset to our organization and the sponsors we support.

Bill Irish

Phase IV Trials

Phase IV trials have become increasingly more common over the past several years and can be designed to answer specific economic evaluation questions. Strengths of this approach include:

  • Reduction of bias through random allocation 
  • Possibility of broader results generalizability across populations

Challenges of this approach include

  • Comparison of more than two or three treatment options
  • lack of long term follow up 

CTI's HECOR team has experience that can help our clients navigate through the complexity of decisions concerning where to obtain the required health resource utilization data.

 

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