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Key Elements Of Observational Studies That Make Major Contributions To The Literature
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•Article: Key Elements Of Observational Studies That Make Major Contributions To The Literature
By Dave P. Miller, Sr. Director Statiatical Analysis, ICON Late Phase & Outsomes Reasearch
While publications are by no means the only measure of success in an observational study, the presentation of abstracts and the later publication of peer-reviewed manuscripts are among the most visible and lasting markers for success.
As a statistician with a long history of co-authoring results from observational studies, I am often asked which statistical tools are critical for observational as opposed to randomized studies. While observational study statisticians do have their own specialized statistical tools, success has much more to do with process than with statistical methodology.
Every highly successful program in which I have participated has included three key elements: (1) A protocol that asks clinical questions that will be interesting regardless of the results, (2) External advisors who are actively engaged and (3) An analysis approach that is modifi able. Each of these elements is discussed in more detail below.
A protocol that asks clinical questions that will be interesting regardless of the results
There is no shortage of interesting clinical questions, but selecting appropriate questions for observational research is a balancing
act. Some of the most interesting high-value questions have
potential for strikingly positive or negative findings.
External advisors who are actively engaged
It should go without saying that advisory boards need to give good advice and steering committees need to steer projects. From experience this is only true about half the time, but it is universally true of successful projects.
An analysis approach that is modifi able
Observational studies need an approach that allows for exploration of multiple objectives and an ability to adapt to identifi ed strengths and weaknesses in the data. Therefore the initial analysis plan may be very simple and descriptive, with the expectation that it will be further developed once the baseline data is better understood.
•Article: Key Elements Of Observational Studies That Make Major Contributions To The Literature
