Public education campaigns and more sophisticated web-based tools are needed to overcome barriers to patient recruitment for clinical trials, a new report suggests.

As many as 90% of trials suffer delays and the majority of these are attributed to patient recruitment problems, notes the report by independent market analyst Datamonitor. The growing size and complexity of studies, with thousands of patients required for a single trial, has made the process even more challenging.

Patient recruitment absorbs more time than any other stage of a clinical trial, Datamonitor observes. Dwindling recruitment rates mean delays, and very costly delays at that. Trial sponsors can lose anything from US$600,000 to US$8 million for every extra day of clinical development. Moreover, delays may even result in loss of a first-to-market position, which can cost millions in potential revenue over the lifespan of a drug.

One impediment to recruitment is the general public’s “largely very negative” perception of the clinical trial process and the pharmaceutical industry in general, Datamonitor believes. This impression has been fuelled by extensive media coverage of drug withdrawals and deaths of study volunteers.

“Due to this ill-informed portrayal, patients are reluctant to participate in clinical trials,” comments pharmaceutical analyst Maura Musciacco, expressing concern that “US$500 million is spent annually on mass-media patient recruitment advertising and promotion, yet less than 15% of the public have a basic understanding of clinical research”.

The remedy, Datamonitor proposes, is to ‘rebrand’ clinical trials through large-scale educational campaigns such as the ‘Everyday Heroes’ initiative launched by Eli Lilly in the US in 2006. “This was done to send the message that participating in clinical trials is a good and noble thing to do, in addition to changing the image of the people who volunteer from ‘guinea pig’ to ‘hero’,” it explains.

Although the campaign was not designed to recruit patients, Datamonitor adds, Lilly has found that running it in combination with its recruitment advertisements has boosted monthly enrolment by more than 35%.

Go online

But the key channel for improving recruitment, suggests the report on Online Patient Recruitment Strategies – Optimising the Clinical Trial Process, is the internet. It has a much wider and faster reach than the traditional approach of recruiting patients through their doctor and is much less expensive than using media such as television, radio, billboards or newspapers, which also offer limited opportunities to supply educational material.

“With internet penetration booming, websites can reach populations all over the world at a remarkable rate,” Datamonitor comments. Uniquely, web-based tools provide a targeted and on-demand service. According to the analysts, research has shown that internet surfers tend to be more interested in clinical trials than people looking at posters in a clinic.

Moreover, targeting – finding the right patients as well as the right number of patients – is increasingly important as the size and scope of trials expand and the competition for volunteers gets tougher. Nonetheless, Musciacco cautions, “it must be kept in mind that it is the synergy of all methods (doctor, media and internet) which will ultimately increase patient enrolment”.

Web-based tools can also educate patients by supplying them with more information than conventional recruitment channels, Musciacco points out, adding that, whether people decide to take part in a trial or not, “they have learned about the new treatment”.

The main barrier to use of the internet as a recruitment tool is that often patients do not know where to look for information. This means websites need to be user-friendly, with complete and up-to-date information that can be understood by the general public, Datamonitor emphasises.

Specialists in the field are talking about a more ‘patient-centric’ approach to attracting and recruiting trial volunteers, it notes. This also helps to prevent patients from dropping out before the study is completed, by making them feel like a valued part of the process. Patient retention is often overlooked but “if more focus is placed on it, it will save companies a lot of money”, Musciacco comments.

When designing an online recruitment strategy, it is crucial to take into consideration the patients’ needs, maintain a two-way communication, ensure the transparency of the project even after it is completed and to keep pushing for awareness and education, Datamonitor says, adding: “Last but not least: keep patients informed to foster commitment and compliance to the trial”.

At the moment, only about 20% of patients are recruited for clinical trials through the internet. The trend will escalate, Musciacco believes, “as patients become more proactive and the increasing internet penetration aids in spreading information”. All the same, pharmaceutical companies “should start their recruitment as early as possible and must increase their promotion in order to boost patient awareness”.