Recruitment reigns at DIA

June 18, 2010 – 6:06 pm by Michael Christel

Patient recruitment and retention was a major theme at this week’s 46^th DIA Annual Meeting in Washington, both in the educational sessions and on the show floor. By my count, the conference featured at least 11 panels exploring the topic, ranging in focus from who should be accountable for patient enrollment, to defining realistic recruitment feasibility, to best practices for reaching and supporting clinical trial participants in the digital age.

“This whole phenomenon of patient recruitment and trying to influence driving the cycle time down by getting patients into trials faster is a relatively new element of all the types of activities that take place in a clinical trial,” Jim Kremidas, VP, global head of patient recruitment at Quintiles, told me during a sit-down at the event. “When you ask people who’s accountable for enrollment, depending on who you ask, you get a different answer. Because there’s not really a clearly defined process like there might be for data management or statistical analysis or [clinical trial] monitoring. We’re sort of the fledging group in the whole continuum of clinical trial practice.”

Mr. Kremidas took part in four DIA sessions on patient recruitment, including a town hall discussion examining the question of who really is accountable – amid the industry’s much chronicled study start-up and timeline woes – for ensuring an investigative site delivers enough quality patients and data.

“Asking that question is like saying, who’s accountable if a football team wins a game? It’s everybody,” Mr. Kremidas says. “Each player has to play their role and they’ve got to play it well. In a clinical trial, the CRA (clinical research associate) has got to be doing the right thing; the project manager and the site staff have to be doing the right thing; people like what I do – developing communication materials – we need to make sure we get the right message, and we need to make sure we get that message to the patient at the right point in time. It’s a very complex strategy that needs to be developed upfront. Roles and responsibilities need to be assigned. Anybody who touches any part of recruitment needs to do it well.”

Because of the complex terrain, Mr. Kremidas says using centralized outreach tools at the site level is especially important, particularly for trials involving chronic diseases like diabetes and pain where patients can self-report. The recruitment component controlled centrally in these cases, he says, is the message being delivered to prospective patients and the understanding of which medium for delivery makes the most sense in the markets around the site.

“It’s targeted toward a specific patient type, and then we help choose the media that that patient type would typically be using,” Mr. Kremidas says. “It might be the Internet, it might be television, it might be radio, it might be print. Social media would fit in there, too.”

Mr. Kremidas, who spent 24 years at Lilly before joining Quintiles in 2008, is on the advisory board of the Center for Information and Study on Clinical Research Participation, known as CISCRP, a non-profit group that promotes education and awareness of clinical research participation. CISCRP, which presented its annual 2009-2010 report in Washington Monday, is supported by 362 organizations from clinical research and healthcare.

“We have a statistic that shows when you ask people about why they’ve never been in a clinical trial, over 70% say because they didn’t know about the trial,” Mr. Kremidas says. “As an industry, we need to do more to reach out to patients and educate them about what it means to volunteer for a trial and how you go about doing it.”

Patients, however, are generally becoming more adept at being their own advocate for healthcare, according to Mr. Kremidas.

“It’s not where it needs to be, but as more information is available through technology, the Web, people are going to learn more about what type of healthcare options they have,” he says.

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There was plenty of patient recruitment buzz in the DIA exhibit hall as well. Boston-based recruitment company BBK Worldwide, for example, unveiled its Patient Recruitment Franchise Program, headlined by the FRANCHISE e-BINDER, a communication platform that uses the Apple iPad to orchestrate the numerous tasks associated with recruiting and managing patients for global clinical trials.

Also, marketing agency Blue Chip officially launched its own standalone patient recruitment division called Blue Chip Patient Recruitment, expanding on the company’s 15 years of experience as a partner in the patient acquisition and retention space. The new group’s first client is BioSante Pharmaceuticals Inc., where Blue Chip is conducting a patient recruitment marketing program for the Bloom Study, a Phase III trial testing the safety and efficacy of BioSante drug candidate LibiGel for the treatment of hypoactive sexual desire disorder.

“It’s an amazing disease state, a lot of demand,” Ken Shore, executive VP of Blue Chip Patient Recruitment, told me at DIA. “There’s a lot of prescriptions written off-label for the condition, so there’s clearly an opportunity there.”

In the Bloom Study, 5,000 patients have been recruited for three different protocols and 160 sites.

Before starting its own patient recruitment arm this year, Blue Chip, under a partnership with The Essential Group, was involved in recruitment marketing for 600 clinical trials over a 14-year period. Other patient recruitment clients have included Novartis, J&J, Pfizer, AstraZeneca, Abbott, and Takeda.

“A lot of times, sponsors will approach patient recruitment agencies like Blue Chip with a very defined expectation and a very limited role for the agency to play,” Mr. Shore says. “Often times, the agency will contribute more than what they’re being asked to, but for a variety of reasons – mostly cultural – they’re put in a box. In BioSante’s case, there was a big box. They engaged Blue Chip, literally putting everything on the table, and said, ‘OK, here’s where we are, here’s where we need to get to, and any and every idea is a good one.’ They really view us as a true partner.”