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 write 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. We are also happy to visit in person and make a PowerPoint presentation to your staff if that will help.

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; acting as the contracting CRO to manage the trial; 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.

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