Recruitment in STEP-BD Posted on December 3, 2007 In STEP-BD, attracting participants was easier than securing clinicians' agreement on randomization, Gary S. Sachs (bio) recalls.

The experience of STEP-BD regarding recruitment was really unexpected. We started out with a value proposition. We were going to give excellent care and produce known results. That was the tagline that we had out there for people.

But there was a lot of reason to believe that maybe that by itself wasn’t going to be enough. And the NIMH was helpful. They had an idea that they could get some public service announcements about the study that would be played out in a handful of cities and, “Let’s see how that goes.” That was going to be the beginning. That turned out to be the end, because those public service announcements were made and overnight the centers in those cities were swamped with calls.

It turned out that for STEP, the value proposition that we had was absolutely enough. We recruited over 4,000 patients. The idea of doing something that’s really in the patient’s interest to do was sufficient to get us the recruitment that we needed.

The real challenge was helping the staff at the centers understand why beyond delivering clinical care, getting people into the randomized parts of the study, the parts that would give very high-quality answers to the scientific questions that we were most interested in, it was hard to get the clinicians to appreciate why that was so necessary, which was a bit of a surprise to us.

Once we realized that just teaching some of the basics of evidence-based medicine, what we really knew and didn’t know, and the idea of being at clinical equipoise and needing to decide whether this recommended treatment A is better than that recommended treatment B. Once we did that, the rate of randomization really picked up and that became a regular part of the yearly training that we did with the site personnel — really helpful.

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