What drives the cost of clinical trials

The total cost of a clinical trial depends on many variables, but the main cost factors are: 

  1. the number of participants, and 
  2. the complexity of the clinical trial protocol.

Firstly, the number of participants in a clinical trial is highly related with the study phase. For instance, phase 1 clinical trials —which are focused on evaluating drug safety— recruit an average of 20-80 patients.Phase 2 trials —which analyze safety, dosing, and preliminary efficacy— normally include between 100 and 300 participants. Later stage phase 3 clinical trials are larger studies assessing safety and efficacy and can enroll several patients depending on the therapeutic area (between 300-3,000 participants).

How much do hospitals charge for each patient treated in a clinical trial?
The amount of money to be paid by the Sponsor to the clinical sites in which the patients are treated —to cover medical procedures and tests— varies across study types, but in the U.S. this can go from US$20,000 up to US$70,000 per patient. 


How much does it cost to pack, label, store, and distribute a drug in a clinical trial?
The cost of packaging, labeling, storing, and distributing a drug in a clinical trial may be in the range of US$40,000 to 100,000 per study.

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Source: https://www.sofpromed.com/what-is-the-cost-of-a-clinical-trial



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