Orexigen rethinks clinical trial recruitment

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2012 ushered in a new era in weight-loss drugs, with the FDA's reversal on treatments such as Vivus Pharmaceutical's Qsymia and Arena's Belviq, but a potential competitor's recent success may shake up the clinical trial space.

Orexigen, which is hoping to enter the weight-loss category with its experimental drug Contrave, has introduced a new way of thinking about clinical trials—one that's shrunk its ramp-up time by over a year. The secret: treat clinical trials like product launches and start with a multi-pronged, consumer-friendly pitch.

By foregoing the traditional slow-burn recruitment flow that typically begins with approaching a research organization and expands to include third-party recruitment when numbers lag, Orexigen did it all at once and managed to shave off 14 months from what was expected to be a two-year process. The goal was 9,000 patients and the company garnered 100,000 responses.

“There's a good chance if they took two years to run and operate this study that [Orexigen] wouldn't have made it to the finish line” Blue Chip's EVP Neil Weisman told MM&M. Marketing firm Blue Chip, which Weisman said would traditionally be brought in as a company sought to scrape up final numbers, was instead brought in at the beginning and helped shape a messaging approach from both the clinical and patient perspective. This meant treating recruitment like a product launch, which translated into recruiting materials that resonated with patients and understanding how patients perceive themselves—typical for advertising, but novel for clinical trials.

For example, Weisman said the patients they were targeting reacted negatively to the terms “very overweight” and “obese," and that only a quarter of the patients who met the Contrave profile actually considered themselves "very overweight," while 75% said they were "a little bit overweight." Accordingly, marketing materials eschewed those loaded terms.

The media mix included paid search, social media, television, traditional print media and direct marketing. Weisman said direct marketing proved to be the most effective recruiting tool. The website featured sales-like language ("A new approach to long-term weight management," "Get started today") and a clean and airy presentation aimed at informing but not overwhelming. The style was basic—but not unbranded, and by implication unimportant.

Further, Orexigen and Blue Chip deployed a variation of the detail rep. In this case, they sent out “clinical enrollment specialists” who provided messaging continuity and guidance to clinical research organizations.

Weisman summarized the typical CRO recruitment strategy as follows: tapping into practice databases, and using that as a springboard for a phone call or a letter inviting them to talk about an opportunity. Weisman said the problem is that this approach “is not necessarily driving traffic.”

The solution was a more dynamic strategy that has more of a consumer-training feel. Orexigen's enrollment specialists consisted of a crew of professionals who had years of clinical trial field experience and who came equipped with not just recruitment plans but also with tools like empathy training, which helped local recruiters connect with patients and clearly articulate trial goals. Weisman said the aim was that “every individual who got to the site . . . was converted at the highest possible conversion rate.” In other words, recruitment centers took a retail approach to patient relationships.

Clinical enrollment specialists regularly checked in with recruiters to field questions and track progress. Weisman said study coordinators “loved this program” because the specialists had the background to provide substantive support. He also said the "high-touch" approach kept the study “top of mind at these clinics,” which is an important factor since sites typically juggle more than one trial at a time.

Weisman said that the campaign's outreach remained fluid and responsive to feedback, from its May launch until they hit their recruiting goal the week before Christmas.

“There were literally thousands of changes,” he said.
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