Organizing STEP-BD Posted on December 3, 2007 Gary S. Sachs (bio) stresses the significance of determining, and delivering on, a project's value to each person involved.

STEP-BD was a very large and complex project that took eight years from approval to completion. And there were a number of lessons which really were very important there. As I was starting to work on it and meeting with people, seemingly endless sorts of meetings, some of which were very discouraging, early on some of the people at our hospital who picked up on what this idea was and how important it was, helped me understand the importance of communicating it clearly.

It really was a challenge of people didn’t understand what the RFP was about, didn’t understand what our proposal was about, how important it would be to have a concise, very short presentation just to give people a consistent picture of what we were talking about. And then also how you organized the operational aspects of the study. What was the executive committee doing? What were the operations people doing? What about the regulatory part of this? How were you going to deal with the sites? Who was going to manage the statistics?

The organizational chart that I was encouraged to make early on turned out to be actually one of the very best communication tools, because it showed people more or less how everything was going to work at a glance.

And whenever there were problems, to go back and look at that organizational chart and say, “Actually, this training piece falls under this particular person and that’s how it relates to the operational aspects of the study." To have the standard operating procedures down in manuals, to explain the details over and over again to people, that was impossible. But to refer them to those sources and to have very good people in each of those roles, that was key in making the project work.

The other very important aspect of STEP, which I think applies more generally to all research: it’s very clear that people don’t do things all for the same reason. There are different value propositions for perhaps you as the PI, you may want to get your paper out. You need to advance your career. You want to become professor of psychiatry. You want to get your K award or your R01. But your motivations are not necessarily the same as the person who might have face-to-face contact with the patient in a distant site or even in your own site.

And questioning at the beginning, “What is the value proposition for each and every person involved in the study?” and making sure that it actually is a proposition that you and the project can deliver, I think that’s critical to success.

So when you imagine this wonderful project for advancing science, ask yourself, “Why should any subject participate in that? Why should the research assistants do their job? Why should the statistician do their job?” And if you have no answer for any of those, stop right there. Get the answer. Change the design of the study, or you can know that this may not work.

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