It was in a February 2011 article that appeared in Pharma Voice that revealed the startling statistic that 80 percent of clinical trials are delayed due to recruitment issues. When you factor in that 50 percent of studies fail to meet their recruitment targets and 50 percent are delayed due to insufficient recruitment, it goes to show how patient recruitment continues to present major obstacles in clinical operations. What’s more, once patients are enrolled, investigators continue to oversee high dropout rates, all the more exacerbated by over estimation at the feasibility stage.
In the drug development process, patient recruitment (and retention) has a significant bearing on the outcome of a clinical trial. Getting to the root of enrolment issues and finding ways to mitigate recruitment challenges is critical to ensuring success. So what can sponsors do to improve recruitment practices? Here are three things to consider:
As ever, good site selection is key to finding the right patients for your trial. Past performance is typically a precursor of future returns as a well run site will deliver more often than not. One of the common hurdles for patient recruitment is the distance between sites and patients, so strategically select sites that are easily accessible to participants. If enlisting a CRO to conduct your trial, measure how well they know the therapeutic area of the study, while considering their track record if they’ve worked on similar trials.
Be thorough with your CRO when assessing their recruitment processes, bearing in mind that it’s not enough for them to say they can recruit 10 patients. Probe and understand how they will recruit them. If your CRO normally advertises to recruit patients, ask what their response rate was. If they use their own database, can they preselect patients, and so forth. However, once the trial is underway, if recruitment is slow going, don’t be afraid to cut your losses. Develop a contingency plan by having back-up sites in place.
Advertising (traditional media)
While some experts say 75 percent of patient recruitment comes from good site selection, the other 25 percent boils down to an effective advertising strategy. When reaching out to potential patients, always consider the ways in which your target demographic consumes information. For instance, if you’re targeting the elderly, consider advertising in elderly magazines, on the radio, in newspapers, and so forth. While these methods aren’t groundbreaking, the key to recruitment success is how you’re able to manage public response to ads.
Call centres can be effective and is probably the most established way of managing public interest to trials. CROs and clinical trial units, in particular, have the capacity to handle and follow up on prospective enquiries. Ensure you have in place medically qualified personnel who can take the calls. Have them use a phone script for high level screening before referring the patient to the nearest site location.
Another way to boost faster response times is through the use of SMS text messaging. If you set up a system whereby you facilitate an open dialogue with a prospective patient, you can pre-screen them to gauge their suitability for the trial.
Harness the Power of the Internet
Lastly, the power of the Internet cannot be overstated. When used to maximum effect, the Internet can enhance recruitment rates and boost your chances of success. Sites such as ClinicalTrials.gov lead the way in drawing patients to the relevant studies. Leading companies like Janssen have created disease specific sites, an approach ideally suited to larger sponsors with multiple studies in a therapeutic area. Nevertheless, creating disease related websites should not be overlooked, even if you’re a small or medium sized company.
Think outside the box by learning where your patients are surfing, and learn where to find them on the Internet. Online ads are another effective tool that shouldn’t be underestimated. Programmatic advertising (e.g. banner ads) can be used on multiple websites using algorithms to track and identify potential patients. If, for instance, a prospective patient enters the search terms into YouTube that are triggers, the video they view could be preceded by an advert for your clinical trial. Although such a tactic may seem like a shot in the dark, programmatic advertising could bring a sponsor closer to patients, and improve their recruitment strategy.
- Treweek S, et al. Cochrane Database Syst Rev. 2010 Jan;
- Sahoo, “Patient Recruitment and Retention in Clinical Trials”. Emerging strategies in Europe, the US and Asia”, 2007, Business Insights Ltd;
- Quintiles white paper: the key to successful study start-up
- Diderik Boot, Considering innovative methods for patient recruitment to increase patient populations effectively (Presentation)