When recruiting patients for clinical trials, multiple things can go wrong. The majority of us have likely encountered at least one horror story involving huge patient recruitment budgets that resulted in miniscule measurable results. These pervasive stories enable the continuation of a commonly held feeling of skepticism about the value of patient recruitment services. The “when things go wrong” story is passé and should be replaced with the “when things go right” story. One of the best ways to ensure patient recruitment success is to set up the program correctly from the start.
In order to successfully set up a patient recruitment program, you need to begin with sound strategy. Sound strategy should be based on concrete facts and not simply chosen from a list of vendor services.
There are six main factors to consider when developing strategy.
1. Who are we trying to recruit? This includes patient demographic information such as gender, age and diagnosis. These considerations should encompass caregivers if relevant to the study population. The messaging and outreach should be targeted to this defined audience or patient profile.
2. Where are these patients? This is the geography and logistic information that is gathered to ensure you are messaging in the right locations. This can include characteristics of local health communities, the environment and the available patient population.
3. How can you reach the patients? This is a paramount question that forms the basis of your outreach strategy. Market research based on social listening can provide insight into what types of online behaviors would be best to advertise on for online media outreach. Other insights, such as site referral networks, can lead to grass roots outreach approaches.
4. How can we increase participation? This is an important question that leads to discovery of potential patient barriers and allows proactive solutions to be built into the strategy. Providing patient education on clinical trials, looking at other services such as transportation assistance programs or compensation reimbursement solutions can mitigate risks to prevent enrollment goals from being met.
5. How many patients do we need? This enrollment modeling is paramount to creating a patient funnel. The top of the funnel starts with the available population. Next is the people with the diagnosis, then the patients who meet all the inclusion/exclusion criteria. What follows are those people who are willing to participate, and of those how many are near an open and enrolling site. It provides a realistic look at the fall out rate at each juncture.
6. How long will it realistically take to enroll the study? The enrollment period is critical. This determines if or when you will dial up or down your efforts. It is important to analyze and compare sponsor performance to industry cycle times. Historical data proves useful here but comparisons to studies that have different parameters such as number of sites; recruitment budgets or special populations may not be as useful.
Patient recruitment is not an “add-on” to be included only if enrollment falls behind. It is core to the attainment of enrollment goals. When sound strategy is developed and executed properly, it is a magnificent experience. These accomplishments proves the value of patient recruitment and retention services. The thrill of enrolling faster than anyone else has in a particular disease state and proving the value is the “when things go right” story and one that will be more inescapable as further victories are attained.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. She currently provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to email@example.com.
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