One question raised was whether I was adopting too informal a tone for this grant. For
example, where I had written
If you are a researcher, a member of an Institutional Review Boards (IRB), or a
member of a Data and Safety Monitoring Board (DSMB), you need good statistical tools for
the initial planning and the ongoing monitoring of clinical trials. In particular, you
need to carefully consider the accrual rate--how rapidly are patients being recruited
into your clinical trial.
Members of Institutional Review Boards (IRB), or Data and Safety Monitoring Board
(DSMB), need good statistical tools for the initial planning and the ongoing monitoring
of clinical trials. In particular, they need to carefully consider the accrual rate--how
rapidly are patients being recruited into the clinical trial.
Consider a hypothetical research study that you started in January 1997 with the
intention to recruit 12 patients per year (one per month) over a ten year period, for a
total sample size of 120 patients. By the end of June 2004, (roughly 7 1/2 years), the
study has enrolled 42 patients
Clearly you have problems. Your actual accrual rate is a meager 5.6 patients per
year, and now it is probably too late to fix things. You would have to recruit at a rate
almost 30 patients per year over the remainder of the study to overcome this shortfall.
Let's be honest--you knew it was a bit of a stretch to get 12 patients per year,
and now you have to more than double that accrual rate. Wouldn't it be nicer if you had
noticed the problem two years into the study rather than 7 1/2 years?
and I am told that this is also a problem.
I am of two minds about this. Half of me says play it safe and adopt a slightly more
formal tone. The other half says that a breezy informal style will make my grant stand out in
a good way and get more attention.
I'll probably go with the play it safe mode, but I am curious what readers of this weblog
think.
Other issues where I'd like feedback are in how well we explain the technical details and
if the scope of work is reasonable for a $25K grant.
In the long run, I am looking for collaborators who can help with the preparation of an
NIH grant. In particular, I want people who can provide constructive feedback about the
statistical models we develop and people who can feed accrual dates from actual studies into
our models to see if they produce reasonable results.
