Productivity Trends in Cardiovascular Clinical Trials Open Access

Rus, Alexandru Lenut (2016)

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In order to evaluate and characterize clinical trial cost trends between 1999 and 2012, we retrospectively analyzed existing NIH-funded interventional cardiovascular clinical trials on publicly available NIH and databases. The primary aims of this study were to characterize trial productivity, or outputs per unit of input, and to delineate trends in costs per patient from 1999 to 2012. Study design and data collection included clinical trial analysis with the following question in mind: Has the cost of conducting cardiovascular clinical trials decreased over time? Study results suggest rejection of the initial hypothesis that costs per patient have declined over time, indicating that costs per patient have increased at roughly 15% per year. Consequently, results suggest information technology has not reduced the cost of conducting clinical trials. In addition to outlining several characteristics that may contribute to increasing costs per patient, this research also provides further data on publicly funded clinical trials and contributes to the current body of knowledge on productivity. Results of increasing costs per patient can be used to inform decisions about healthcare, research trial funding, and study design. Further research from both the public and private sector on patient enrollment, trial length, and conditions studied is necessary.

Table of Contents

Chapter 1) Introduction. 1

Foreword: Clinical Trial Significance. 1

Burden of Disease and Risk Factors. 1

Addressing Cardiovascular Disease. 3

Chapter 2) Statement of the problem. 5

Cardiovascular Disability and Cost Concern. 5

Clinical Trial Drivers: Technological Devices, Procedures, and Diagnostics. 7

CVD Trial Drivers: Computers & Information Technology. 10

Clinical Trial Drivers: Drug Development & Drug Therapies. 12

Why Do We Care? Cardiovascular Clinical Trials in Depth. 13

Scope. 14

Chapter 3) Methodology. 15

Selection Criteria. 15

Why Interventional Trials?. 16

Why Federally Funded Trials. 17

Variables Collected. 18

Tracing Data from to NIH RePORTER. 18

Variable Descriptions. 18

Calculation and Graphical design. 21

Outliers. 22

Data Analysis. 23

Chapter 4) Results. 24

Summary Tables and Figures. 24

Result Trends. 29

Chapter 5) Discussion. 32

Strengths and Limitations. 36

Chapter 6) Further Implications.. 38

References. 42

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