Tracking recruitment efforts can become increasingly complex as efforts expand in today’s multifaceted field of patient recruitment, yet tracking is key to developing metrics.
In the early phases of recruitment, sites accepting responsibility for recruiting should have ready access to media results in order to tally weekly reports of media placement. This is the starting point for computing metrics. As a project unfolds, reports can move from weekly to monthly and then quarterly (see Figure 1).
Although recruiters often tend to focus on tallying responses to advertisements, the real goal is to develop metrics that identify which approaches lead to reaching enrollment targets within the contracted time frame.
Efforts to professionalize patient recruiting extend beyond tallying the number of responses to yesterday’s television commercial. The real focus is on using sophisticated methods to attract patients who eventually enroll, are randomized and complete the study in a timely fashion. As these methods unfold during the recruitment period, smart recruiters collect metrics to prove the efficacy of their techniques as they relate to faster enrollment. Quality call centers, for example, recognize that their higher function is data collection leading to enrollment statistics, not merely totaling the number of screened calls.
Collection of metrics should begin from the first day that initiatives are rolled out. As metrics progress, it may be possible to determine the demographics, objective qualities required of subjects, and so on, to fill a study. For example, are patients coming from their physicians’ private practices more likely to complete a study than those recruited externally? What about subjects who self-refer? These types of questions will be answered as the collection of metrics matures at the site level. This is the responsibility in many instances of a centralized recruiter if employed; in numerous cases, however, sites are receiving budget allocations for recruitment and taking on recruitment responsibilities themselves.
The creation of a system to handle recruitment funds and to track the results is essential. This data should be provided to the sponsor on a regular basis. Tracking refers to a number of factors, and allows determination of which strategies provide successful subject referral (see Figure 2). A site’s willingness and ability to help collect this data in a timely manner could become a benchmark to help sponsors differentiate well-organized, experienced sites from less-effective ones. It also suggests a baseline level of responsibility that the site is willing to accept in recruitment efforts.
The ability to move forward knowing which metrics are the most meaningful will result from formal and informal strategic relationships between sponsors and their outsourced partners. However, the site that is in control or understanding of its own recruitment successes—and failures, as well—will ultimately recruit better and faster, and gain the most respect by those who select sites for participation.
Metrics cannot be collected in a vacuum. They must suit the sponsor’s needs to quantify processes that lead to faster clinical development. Without some internal site standards it is difficult to devise critical metrics, but the hope is that all players will eventually come to a common understanding of which documentation is needed to move investigational compounds through the developmental pipeline more quickly. The need for documentation of improved recruitment and enrollment techniques continues to grow as sites develop and mature in their responsibility to deliver upon the enrollment goals—and thus stay competitive and on their game.
In today’s environment, competition for study participation is fierce. The site that takes the lead in working closely with recruitment providers while independently tracking its own site-initiated results will win in the end. Many clinical trial management systems (CTMS) have embedded tools that help support tracking of metrics. In some cases, you may want your CTMS provider to explain such resources that you may not be aware are available. In some instances, reports can be generated automatically. Armed with these data, strategies can quickly be refined and redirected to improve media productivity as the enrollment period unfolds.
Finally, it is important to be mindful of the fact that the most successful recruitment efforts result from good relationships among the sites and sponsors and recruitment providers. When all openly discuss recruitment ideas, we are likely to benefit from each other’s knowledge and experience. Discussion can facilitate creativity and build enthusiasm for a project. When relationships are good, sites are more likely to communicate successes. They are also more willing to confer when problems arise.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to firstname.lastname@example.org.
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