We have a particular client that likes to refer to our enrollment successes as our “secret sauce.” They frequently ask us, “What makes you tick? What motivates your site to achieve enrollment targets both on time and early in some cases?” My response is that the secret sauce recipe includes the internal motivation and characteristics that drive the site team to meet these challenges, but must be stirred well with characteristics of the CRO and Sponsor that encourage site involvement.
As we create our secret sauce, we must carefully measure and strive for a winning combination. Equally important to the outcome is a culture of high achievement at the site. We discuss enrollment progress daily, celebrate goals and set high standards for meeting these goals. Our team members thrive knowing they are performing at a level that will bring the site additional business. We discuss enrollment strategy that we can manage ourselves in our community and encourage creative new ideas. We discuss all studies weekly as a group and report our metrics to the entire staff. Individually, each coordinator is challenged to push for their targets.
Secret sauce recipe for site success
What makes us tick, so to speak, from the perspective of the partnership with the Sponsor and CRO? Perhaps the concept of respect is an important underpinning of the desire to perform well overall. It is much easier to want to do a great job if the recipe includes such elements as: startup payments that are timely, no withholds, fair budget parameters for performance of work, monthly payment terms and consistency in monitoring. It is hard to compete if study A is heads and shoulders above study B as it relates to the business end of the proposition.
Enrollment support is also an essential ingredient in the recipe for success. This can take many forms. Support can be simple or complex in nature based on the needs of the study. Some of the best success comes from the combination of centralized and localized support. In many cases the vital ingredient is sifting and folding in the team approach.
How do we cultivate a team-oriented approach to create that winning tried and true secret sauce? Communication is always a critical element in the process of team building as well as pre-planning and ongoing management of the enrollment process. To quote Roald Amundsen, a team lead from a 1911 South Pole expedition: “Victory awaits him who has everything in order—luck people call it. Defeat is certain for him who has neglected to take the necessary precautions in time; this is called bad luck.” Amundsen led his team to safety, while another team lead on the same mission failed. The missions were identical; however, Amundsen prepared with intensity leading up to the trip and created buffers in the event of catastrophe, while the other leader left himself unprepared and resorted to blaming luck for his team’s misfortunes.
To take our recipe for success to the next level of excellence, we could never create something of worth by leaving out some of the ingredients and failing to plan for the recipe as a whole. As it is with site motivation and successful conduct of a clinical trial, the best way to predict success is to create that success and predict precisely what is needed. Create a proper timeline and adhere to it; if cooked too long or too little, a successful outcome is not guaranteed.
Make sure to shape your own model for success versus leaving a goal, such as enrollment, up to chance. It’s impossible to predict every scenario, but be prepared to handle a multitude of possible outcomes. Plan ahead, especially by drawing from lessons learned in past studies. Perhaps the final analogy relates to conducting research in the model sites are accustomed to. If we don’t enroll patients we don’t get paid. If the food is terrible we don’t eat. Be prepared to try many ingredients before finding the perfect combination for your own secret sauce. Bon appetite!
Jeffrey Adelglass, M.D., F.A.C.S., is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multidiscipline CRO. RAA owns multiple research sites across the U.S. and has performed more than 1,800 clinical trials in multiple disease areas. Email comments and questions to firstname.lastname@example.org.
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