engleski

Economic impact of clinical trials on the health care systems

Advantages of clinical trials (CT) could be divided to direct benefits to the participants (new interventions, drugs, regular and careful medical attention), future patients, medical teams and medical community, science, public health and society in general. Besides benefits mentioned previously, CT could have positive economic impact on the health systems (local and national) as well. Studies which analyzed CT economically were performed only in US with the aim that patient care costs in clinical trials are approximately the same costs (or less) as care delivered in standard therapy. In several studies the costs associated with care in a CT can be less than the care delivered in standard therapy, because the third-party payer is not charged for the drug or treatment under investigation. Considerable economic impact of CT is specially indicated in the system in which all expenses of CT should be covered by the sponsor (industry or specific funds). This approach is presented in European countries and probably leads to health-care budget savings. Treatment costs, diagnostic tests and care costs are covered not only for the patients treated with investigational medicines, but also for the patients on standard therapies. Because of lack of studies in this field some specific investigations have been performed in Croatia. The amount paid by the sponsor to the institutions (hospital overhead, 20-40% from per-patient payment) for 49 regularly ended clinical trials, in which approximately 1400 patients participated, was more than one million Euros (70% from phase III trials). Further, different CT have been analysed from the economic point of view and presented as examples of this approach. In conclusion, there is a lack of economic data of CT, but according to our investigation there is a positive effect on health-care system and it should be emphasized that if the system of complete CT coverage is applied the impact could be considerable.

Economic impact; clinical trials; health care systems

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