Box 3.

—Wasteful practices in clinical trials, which are often “required” by regulatory bodies or companies

• Extensive monitoring and routine verification of data items with “source” (contrary to the principles of randomised trials, where variations “randomise out”)

• Adverse event reporting of individual events, which includes reporting any event, even those that occur during the natural course of the illness (these data are not reviewed by groups conducting the trials, and so it is often impossible to ascertain if the events are drug related)

• Overstandardisation of outcomes by use of extensive adjudication processes (most clinically important events are easily defined and ascertained)

• Complex consent procedures that confuse patients rather than inform them