Patent ID: 7647235

Claim:
A method of performing a clinical trial comprising: performing a first phase of testing, said first phase of testing including administering an active treatment to a first group of a plurality of treatment groups of study participants, and administering a placebo to a remainder of said plurality of treatment groups of study participants, wherein said study participants have been randomized with a processor into said plurality of treatment groups; determining whether each participant in each of said treatment groups is a responder or a non-responder; and performing a second phase of testing, said second phase of testing including administering said placebo to at least one non-responder in at least one group, and administering said active treatment to at least one non-responder in at least one group, wherein data from said first phase of testing and from said second phase of testing are analyzed with a processor, wherein said analyzing comprises determining an effect of active treatment, and wherein said determining an effect of active treatment is performed in accordance with the formula: h = w ⁡ ( n 3 , 1 n ⁡ ( 1 - 2 ⁢ a ) - ( n 1 , 3 + n 2 , 3 ) 2 ⁢ na ) + ( 1 - w ) ⁢ ( n 2 , 1 n 2 , 1 + n 2 , 2 - n 1 , 1 n 1 , 1 + n 1 , 2 ) , where h is a value representative of effectiveness of the treatment, w is a weighting factor, n is the total number of study participants, n 1,1 is the number of participants who were non-responders to placebo in the first phase and were responders to placebo in the second phase, n 1,2 is the number of participants who were non-responders to placebo in the first phase and were non-responders to placebo in the second phase, n 1,3 is the number of participants who were responders to placebo in the first phase and were responders to placebo in the second phase, n 2,1 is the number of participants who were non-responders to placebo in the first phase and were responders to treatment in the second phase, n 2,2 is the number of participants who were non-responders to placebo in the first phase and were non-responders to treatment in the second phase, n 2,3 is the number of participants who were responders to placebo in the first phase and were responders to treatment in the second phase, n 3,1 is the number of participants who were responders to treatment in the first phase, and a is a randomization fraction.