New NIH human subjects requirements will encourage you to befriend statisticians

As if data science experts couldn't get any more valuable, NIH has given us one more reason to bestow chocolate, baked goods, lunches, and other gifts upon our statistician colleagues in order to remain at the top of their long lists of priorities. The new Statistical Design and Power attachment is required for NIH applications that propose a clinical trial.  In this section, you must include statistical power calculations and analysis plans for each Outcome Measure listed in the fields in section 4.3 of the human subjects form.

The Statistical Design and Power attachment must include the following for each outcome measure:

• number of subjects you expect to enroll
• expected effect size
• power
• statistical methods to be used

As you can imagine, it is virtually impossible to write this section well without the full involvement of a qualified statistician. Yes, much of this information will duplication what is included in the Approach section of your Research Strategy, but the attachment requires a more in-depth level of detailed explanation than is often included in the text due to space constraints.