Table 4-1 Costs and benefits of conducting a clinical trial

Party Costs Benefits
Study subject -Direct costs
 Changes in use of health care resources
  (e.g., consumption of substances, drugs
  and services, treatment of possible ADR)
 Changes in use of patient time (e.g., travel
  and waiting time due to frequent visits,
  time for informed consent)

-(Productivity costs)
-Value of volunteerism

-Value of positive outcome (ex post)
  Life-saved
  Productivity saved

-Value of closer relationship with medical
  staff
Sponsor -Resources allocated to a clinical trial
(e.g., monitors, auditors)
-Value of clinical data a
  Study reports
  Published articles

-(Know-how or positive externality)
Investigator -Direct costs
  (Changes in use of health care resources a)
   Changes in use of investigator time

-(Productivity costs)
-Value of clinical data a
  Study reports
  Articles

- (‘Prestige’)
Public
(Patients)
  -(Value of therapeutic effects of mar-
keted drugs (occurred downstream;
should be discounted; determines the
value of data for the sponsor and the
investigator)) a
a These values should not be double-counted.