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Donna Beasley is vice president of operations with Praxis, 5141 Virginia Way, Suite 450, Brentwood, TN 37027, (615) 312-8207, fax (615) 312-8208, email: firstname.lastname@example.org.
Systemized knowledge: experience, insight, and predictive modeling deliver successful enrollment.
In the highly scientific world of clinical research, statistics, facts, and research make up a study protocol's development. Yet one science behind successful implementation of the protocol is often ignored: Marketing. While PharmDs, MDs, and PhDs are called upon to analyze data and formulate a compound, the science of getting qualified patients enrolled in a study is often left to chance. In this critical time when patent expirations are voluminous and the need for new compounds is crucial, sponsors that look to the science of patient recruitment succeed. They succeed in cutting clinical research costs and increasing profitability.
Successful recruitment is the result of a well-planned and strategic marketing program. Marketing involves the study of human behavior. It is the process of promoting a service. In the case of clinical research, the service being promoted is the trial. Numerous variables and influencers involved in the study of human behavior have an impact on marketing. For example, a long-running joke is that men and women are wired differently. Neuroscience has proven, however, that this is no joking matter. And the ramifications of these neurological differences in patient recruitment are tremendous, because women influence 80 percent of all healthcare decisions in a household.
So what are the key differences between the male and female brain? Some significant structural differences include a larger hippocampus in women and a heavier reliance on brain areas that contain mirror neurons. These differences enable women to more easily feel what they see another person is feeling as well as to have a better memory for detailed information than do men.
For marketers who want to appeal to women as effectively as possible, this means that they need to get product design, packaging, pricing, branding, messaging, and more in sync with how the female subconscious mind receives and processes information, and directs behavior. . .1
When these details are right, they greatly increase the chance of marketplace success, that is, enrollment success.
When examining the two clinical trial recruitment ads (marked A and B in Figure 1), it is clear which was designed by a marketing professional armed with the knowledge and experience to motivate people, and which was made by someone without this knowledge or skill. Ad A produced exponentially greater results, yet the media investment required was the same for each. Pairing science-based market research innovation with conventional research enables a better understanding of the elements of successful consumer engagement—providing a powerful tool for generating greater returns on the investment in clinical trials.
Figure 1. Advertisement examples of what works-and does not-in consumer marketing and engagement for clinical trial recruitment.
Patient recruitment is a science, built from experience, research, data, metrics, and the current environment. In addition to the complexities of human behavior, many other variables affect enrollment into a clinical trial. These include the environment, geography, economy, demographics, psychographics, culture, protocol design, treatment options, and the list goes on. A sponsor need not immediately know all the variables involved in recruiting patients or how each might affect enrollment. However, those that succeed know that the design of an enrollment plan requires the same kind of data analyses, research, and strategic planning required to develop the protocol.
Oftentimes the patient enrollment planning is left to a sponsor's procurement specialist who knows very little of the importance of the analysis that goes into creating an optimal recruitment program. The result can be an unproductive plan based on incomplete or inaccurate data. An open dialogue between a recruitment provider and the sponsor's management and clinical teams is critical to identifying the unique variables that affect each study. Knowing the resources available, goals, challenges, and past successes—as well as geographical, lifestyle, and current environmental influencers—is crucial to creating a successful recruitment plan.
Physical scientists are traditionally thought to be more focused on issues of replicability than their social science counterparts. However, years of recruitment data, results, and experience have provided social scientists with the tools necessary to run predictive modeling scenarios that, when implemented, result in predictable, replicable outcomes in the science of patient recruitment.
The predictive model begins with an evaluation of influential variables. Analyses of a protocol and the size and location of its qualifying population can reveal unique enrollment challenges. Then, using primary and secondary marketing and medical resources a communications strategy begins to take shape. A specific protocol's enrollment challenges and the preliminary communications strategy are evaluated against past studies' patient enrollment variables. These include response rates, randomization rates, and disqualifying criteria from those patients with profiles similar to those required of the target protocol. With this information at hand, an experienced team of analysts and recruitment professionals refines the recruitment strategy for the specific target protocol.
Then the team uses predictive modeling to hone the strategy. Running a variety of recruitment scenarios through an algorithm of deliverables develops the optimal strategy for a given recruitment need. This works by using specified metrics and results of the provider's database of patient recruitment data. Analyses of each specific study reveal the most effective and efficient combination of communications tactics. What results is an accurately predicted enrollment outcome, tailored to the timeline and investment the sponsor desires.
The final piece is the people. Just as chemists, pharmacologists, and biologists are critical to developing new drugs, patient recruitment experts and marketing professionals are critical to recruiting subjects successfully. Our proprietary primary research databases and numerous secondary resources provide metrics. The experienced staff identifies the nuances that can uniquely affect a study's enrollment, an ingredient as valuable as any other in honing the strategy for optimal success. It is as important to look forward and to be present as it is to remember the past. The application of current day rationality and the knowledge of the impact present day circumstances can have on future enrollment is the final key element to making enrollment succeed as predicted (Figure 2).
Figure 2. Key elements that are incorporated to achieve the successful enrollment as predicted.
From the differences in male and female brains, to the measured outcomes of years of data, to the application of that knowledge, science in recruitment is abundant. Before a compound is approved as a marketable treatment option, it must have been proven to deliver a predictable result when given as prescribed. To show this predictable result requires years of research, data, and analyses. The same is true for patient recruitment planning.
Years of research, extensive data, and careful analyses provide the ingredients necessary to craft a recruitment program for a specific protocol that delivers a predictable outcome. Then, like the medical doctors who prescribe a marketed drug to an individual, marketing experts use their education, experience, and insight to design a specific recruitment program for an individual protocol. There is a science to reaching and motivating people. Applying such knowledge will result in quicker trial enrollment, reduced research costs, and increased profitability for pharmaceutical and biotech companies.
Donna Beasley is a founding partner and vice president of Praxis.
1. "The Science of Marketing and Gender," Nielsen Wire, March 9, 2009 http://blog.nielsen.com/nielsenwire/consumer/the-science-of-marketing-and-gender/print/.