Abstract

Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billion. Around 75% of the cost is spent on the Phase I-IV clinical research process. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). In the research, the estimated cost of drugs used in the clinical trials for the Turkish reimbursement agency (SGK) was calculated to show the cost of medicines acquired through clinical research. Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. Conclusion: Despite the limitations of the study, the findings are unique for Turkey. The results can lead to revisiting the importance and economic value of clinical trials in Turkey.

Highlights

  • Clinical research is a key component of drug development with a significant economic value

  • The aim of this study was to investigate the economic impact of clinical research to the research centers and the opportunity cost for the reimbursement system in Turkey

  • Industry-sponsored drug research mostly originates in internal medicine and oncology departments (Figure 1)

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Summary

Introduction

Clinical research is a key component of drug development with a significant economic value. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. The results can lead to revisiting the importance and economic value of clinical trials in Turkey. Evidence must be collected in clinical trials for treatment to become routine. The primary drug-focused process in clinical trials commences with defining a molecule in the laboratory. Pre-clinical studies, in which the toxicity and efficacy of the molecule are monitored, are performed on the defined molecule

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