Maximizing randomizations through referral response

Lost-to-follow-up is one of the greatest correctable barriers to completing clinical study patient enrollment

Patient recruitment and retention firm MMG shows how to close the loop…

The most effective method for attracting potential study participants to a site – web outreach, advertising, site referral – is debatable; not as debatable, however, is the screening process. It must begin within 24 to 48 hours after a patient makes initial site contact or a lost referral is the likely outcome. Facilitating sites’ ability to convert referrals into screenings is the most direct way to overcome this challenge.

Referrals lost to follow-up translate to vain spending and lost time, especially as enrollment timelines become increasingly aggressive. Recently, the patient recruitment and retention firm, MMG, helped a large pharmaceutical company and its CRO to complete enrollment in two pivotal trials, after 18 months of recruitment activities had been undertaken.

The challenge

The study sponsor’s goal was to complete enrollment for two parallel dry eye studies within three months (October, November and December 2005). A total of 205 patients were needed. Upon review of the existing program and recruitment environment, the following challenges were identified:

• Low referral-to-screening rate: Study sites were not screening enough referrals, thereby missing many potential study participants. In many cases this was due to poor control over referral volume and a lack of immediate or consistent follow-up or support of sites specific to recruitment outreach.

• Tight timeline: The study needed to close quickly and all recruitment efforts had to start immediately.

• Possible media overexposure: Extensive advertising had already been conducted in most markets.

The solution

MMG put together a recruitment plan that focused on two key areas that could be initiated and implemented in a short time frame – patient awareness and site support.

The first step was to focus advertising dollars on the most effective media. A review of previous advertising analyzed cost per call, cost per referral, referral rates and other factors.

Previous efforts had involved print, radio and TV advertising, direct mail and advocacy outreach. In this case, MMG recommended directing all efforts on print advertising because print had the highest referral rate, could be implemented quickly and could easily be adjusted from one week to the next, maximizing market exposure. A striking photomontage and simple messages – symptoms, availability and call to action – were used in the new ads. Previous advertising had a cost per call of US$140 and a call-to-randomization rate of 2.23 percent. By focusing on key outlets and adjusting advertising away from non-performing publications and sites, the end-of-study campaign delivered a cost per call of US$99 (and therefore yielded more calls and referrals) and a call-to-randomization rate of 2.88 percent.

Focus on motivated sites

Due to the tight timeline, MMG worked only with sites that were able to quickly process referred patients and those that utilized the central IRB. After preliminary surveys by the sponsor and CRO, MMG was presented with an initial list of motivated sites, which were directly contacted to ensure their full engagement.

Weekly calls with sites to follow up on referral response ensured that the highest number of patients were being contacted and screened. In the previous campaign, little regard was paid to the sites’ capacity to respond to referrals. In many cases, sites felt overwhelmed by the resulting referral volume. MMG was able to adjust advertising based on site needs, halting ads if sites were behind, or accelerating outreach if sites were producing results. A central toll-free number was used.

MMG’s in-house contact center prescreened callers for key inclusion and exclusion criteria. Prescreened referrals of motivated and interested patients were then made to sites each day.

Provide sites with assistance and guidance

To enhance and coordinate central recruitment, MMG provided dedicated recruitment specialists to assist sites that were participating in the campaign. These specialists served as the main contacts on issues regarding recruitment, central advertising, outreach, and any other issues. Recruitment specialists tracked the status of referrals and each site’s follow-up.

Site assistance for the study focused on three main areas:

• Setting expectations and goals: Recruitment specialists contacted all sites involved in the program to introduce themselves and the campaign. They also walked site staff through the referral tracking procedures that MMG would be using and explained contact center functions. This helped set specific, mutual expectations for referral follow-up and gauge sites’ overall approach to the program.

• Coordinating advertising: Individual advertising plans were developed and approved by the sponsor and each site. Giving sites a say in when and where advertising would run helped to ensure their ‘buy-in’ and commitment to the campaign. Weekly plans were communicated and adjustments were made based on a given site’s ability to screen referrals and handle patient flow. This was monitored through electronic data collection and phone contact with the sites.

• Referral tracking: The most important role involved assisting sites with referral follow-up and maintaining their focus on screening. As the contact center prescreened and referred potential study participants, recruitment specialists followed up to verify that each site had received the referrals and determined the status of each referred caller. MMG was able to track referral status through the screening and enrollment process and motivate sites to respond to referrals in a timely manner. Sites that were unable or unwilling to communicate follow-up information were denied additional advertising or referrals.

The results

The results for this recruitment program greatly exceeded expectations. Both studies closed in the projected time frame and recorded very high enrollment numbers in the final three months. Of the additional 205 patients needed at the start of MMG’s involvement, 104 – more than half – came directly from advertising. Although sites previously claimed that their patient bases were depleted, the steady stream of referrals and regular contact motivated sites to enroll the remaining 101 patients. Call volume was 187 percent more than projected, and nearly three times as many referrals were made as had been projected. Sites reported follow-up on 80 percent of all referrals sent, and this number could have been higher if one of the studies had not closed early, negating the need for more randomizations.

Beyond the fact that recruitment for the trials was completed on time, MMG’s program was also cost effective. A projected cost per randomization of US$8000 was reduced to approximately US$3500.

Best practices

As competition for patients continues to increase, dedication to sites and site follow-up are required for other outreach efforts to succeed. In the past, patient recruitment firms were unable to accurately track success or influence follow-up. It is no longer sufficient simply to place advertising or web-based outreach efforts and hope that sites will handle the rest. It is also becoming much more important to systematically track the results and success of patient recruitment efforts. Patient enrollment firms must be able to justify their efforts and show real results – both in terms of patients and cost efficiency.

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