Large Cost Savings, Large Time Savings, etc., -  10 Real Cases where Founder has Already Provided this for Sponsors

5 Real Cases where Founder's Biostatistical Consulting on Adaptive Trial Design or Group-Sequential Design Provided Sponsors with Large Cost Savings, Large Time Savings, etc.

1. 31% Reduction in the expected Number of Patients for a Phase III Oncology Clinical Trial

2. 4.6 Month Reduction in expected Duration of a Phase III Endocrinology Clinical Trial.  Founder's further Input also Reduced required Number of Patients by 81

3. 4.0 Month Reduction in expected Duration of a Phase III Oncology Clinical Trial

4. One Positive Phase III Cardiovascular Clinical Trial that likely would have been Negative Without the Adaptation

5. Power increase from 80% to 90% which Provides the equivalent (for primary efficacy) of 34% Extra Patients at No Cost, in a Phase III Cardiovascular Clinical Trial

5 Further Real Cases where Founder's Consulting on Other Biostatistical Design or Analysis Approaches Provided Sponsors with Large Cost Savings, Large Time Savings, etc.

1. $2.0 Million Reduction in Cost of Phase III GI program

2. 180 Fewer Patients Needed in Total (i.e., 90 Patients Fewer per Study), thereby Reducing Sponsor's Costs in 2 Phase III Dermatology Clinical Trials

3. 10.4% Reduction in Sample Size for a Phase III Oncology Clinical Trial

4. 2.8 Month Reduction in Time to NDA Submission for an Endocrinology Clinical program

5. $53 Million Increase in Expected Sales for a CNS program with 3 Phase III Clinical Trials resulting from biostatistical input which: (a) increased chance of early approval (after first 2 trials); and (b) increased overall chance of any approval

Large Savings from Adaptive Trial Design or Group-Sequential Design

Note: In all 10 examples given here, reductions in sample size, or in expected duration, were obtained without any loss in power.