You’ve spent a lot of time and effort conducting a clinical study and
now you find that it’s flawed either when it comes time to try and get
it published, or because a systematic reviewer finds the problems.

It doesn’t have to be this way.

Most clinicians
aren’t trained in clinical design of studies, and it’s one thing to
understand clinical study design in general and another to organize the
protocol for a study. We can help. We can either offer a brief critique
or we can help you design the study from scratch and generate a
protocol’your choice.

Some examples of design flaws:

  • Data in a cohort study that is massively skewed with regard to
    patient parameters because data was not collected in proportion to each
    patient enrolled.
  • An RCT that has so many exclusion criteria that it doesn’t have much relevance to real clinical practice.
  • A case-control study that hasn’t properly matched control subjects to the experimental subjects.
  • Loss to follow-up in a longitudinal study that is excessive
  • RCTS that don’t adhere to the CONSORT protocol
  • A non-inferiority RCT design in which the study is powered to detect only a 25% difference in the primary outcome parameters.
  • A comparative design in which there are major differences between groups with regard to study parameters at baseline.

A dollar well spent at the design stage is worth hundreds spent at
the execution stage. Be clear in what your objectives are, what you
would like to demonstrate. Rigorously examine your protocols. Ask tough
questions: what if? If you don’t ask the tough questions, it’s almost
certain a reviewer will after the study is complete and then it’s too
usually too late to fix problems.

Most journals are now getting a
lot tougher about all the other items that go with designing a trial,
too. If your study is testing an intervention or treatment, you should
get it registered before you start (for example, with clinicaltrials.gov).
Are you sure you don’t need an IRB approval for a study? Think again!
Many journals are now insisting on this, even for trivial or routine
care studies, whether we think that’s a good idea or not. It’s not hard
to set up an institutional IRB, so this should not pose a barrier to
your studies, and we can advise you on this aspect if you need
assistance.

The Study from soup to nuts

We don’t just offer the capability to design the study. We are also
capable of performing sample size calculations (frequentist statistical
or Bayesian); writing the protocol; working with agencies or IRBs for
submission and protocol amendments; monitoring trials or studies or
regulatory issues (we can call on very experienced personnel for these
issues); analysis (frequentist statistics or Bayesian approach); and
publication of the study/trial.

We don’t want you to feel that you have to find dozens of experts to do a study; we can arrange all of it for you.