With patient recruitment becoming more acknowledged as a factor in the success of a trial, many trial managers are recognizing that proactive patient recruitment measures are necessary during the planning phase in order to mitigate risks.
Although it may occur from time to time, it is rare that sites fully enroll trials from their databases. Industry data also suggests that fewer than 4% of all U.S. physicians participate in clinical trials. With limited numbers of physicians and eligible patients, planning for patient recruitment is essential.
Even with recruitment planning, more than two-thirds of sites continue to fail to meet their enrollment goals, and an astounding 15-20% of sites never even enroll a single patient. Even worse are statistics from Harris Interactive, which reveal study results showing that while 44% of people find out about studies through the media, only 14% gain the information from their physicians.
With those metrics in mind, we must ask: What are the most effective strategies to increase patient enrollment rates and reduce the percentage of sites that never enroll?
Mistakes sites make when advertising clinical trials
Unfortunately, it’s the lack of strategy (or planning) that leads to enrollment failures. When teams deploy the wait-and-see approach, the patient recruitment strategy’s effectiveness is diminished and budgets are higher. And because the timelines are shorter, site communications are rushed and often compromised, which leads to confusion, lack of clear expectations and less-than-optimal results. This type of planning is often called “rescue recruiting”—and while it may increase participation, it will never be as effective as implementing a campaign from the beginning of a clinical trial.
Another common approach is for trial teams to provide a “standard site stipend for local advertising.” Although this approach assumes that at least some sites will need to reach patients outside of their database, it also falls short.
In the “standard site stipend” scenario, sites are allowed a modest amount of budget to do local advertising. An average stipend amount allotted per site is about $5,000. Providing sites with some advertising funding at least acknowledges that they may have to depend on a source other than their own patient records. While such an approach also can bring in patients from outside a site’s database, it has significant limitations. For example, although some sites have in-house teams experienced in local advertising, the majority do not. Advertising for a clinical trial is a very specialized area and, as outlined in the chart above, there are several mistakes that sites could easily make when doing so.
In addition, when sites are tasked to manage their own recruitment, we see duplication of sponsor reviews and IRB submission fees. The time spent on reviewing each site’s local newspaper ad would be better spent on creating a unified print ad that could be distributed for all sites to use, as opposed to having each site create its own material.
The most effective approach to the patient recruitment challenge is to proactively plan and create unified messaging and materials, and to deploy a strategic outreach plan. That’s because, statistically speaking, we already know that most sites are not able to fully enroll from their databases. We need to proactively provide the sites with consistent tools and outside referrals.
While it is true that about 80% of patients come from within the sites’ population, that leaves a gap of 20% from outside sources to be considered. Those outside sources or recruitment tactics will vary across disease states and patient demographics, but should be strategic and centrally managed in order to be as effective as possible. Having a unified look and feel with consistent study messaging—and leaving the advertisement placement to experts who understand marketing—affords the site more time to devote to the recruitment activities that take place inside the site environment.
Effective patient recruitment planning is not a one-size-fits-all approach, but rather a strategic and focused effort launched in a timely manner so that sites can focus on what they do best: conducting clinical trials.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as principal consultant of Accelerate Clinical Enrollment. Email comments and suggestions to email@example.com.
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