Four Key Considerations for Recruiting an Undiagnosed Population

For many patients, the journey to a clinical trial does not begin with a diagnosis, it begins with unanswered questions. Whether they are navigating persistent symptoms, limited access to testing, or a healthcare experience that has left them feeling unheard, undiagnosed patients represent a population that requires thoughtful, empathetic recruitment strategies.

Continue reading to learn about four important factors to consider before recruiting for an undiagnosed population.

While patients may go undiagnosed due to the rarity of their disease, others are undiagnosed due to lack of accessibility to healthcare. Uninsured or underinsured patients may have coverage denied or need to pay out of pocket for expensive diagnostic tests such as biopsies, cancer screenings or genomic testing. Providing coverage for these tests during the screening process can reduce patient burden and increase recruitment by widening the potential participant pool.

Approach patients in a tactful and respectful manner, keeping in mind the healthcare journey it has taken for them to turn to clinical research. Patients may feel dismissed by healthcare professionals and feel unheard after going months or even years without a diagnosis. They may feel drained from the amount of testing they have had to do, and they may come in discouraged with little expectations to find answers. In order to build a trusting relationship, consider the following:

• Use active listening skills, parrot their frustrations and provide ample time for discussion Consider the participants’ needs when determining things such as travel to site, communication preferences, appointment availability and more. Offer flexible scheduling and travel support services such as mileage reimbursement or rideshare services. Keep in mind the symptoms of the patient and the limitations they may be experiencing and tailor your approach to each individual.

• Consider the participants’ needs when determining things such as travel to site, communication preferences, appointment availability and more.

• Offer flexible scheduling and travel support services such as mileage reimbursement or rideshare services.

• Keep in mind the symptoms of the patient and the limitations they may be experiencing and tailor your approach to each individual.

A patient may have received a diagnosis, but is it the right one? Consider how the current treatments are affecting the patient and if they have had any relief from their symptoms . If the patient is still looking for answers, you should be too . A diagnosis of IBS in a young adult could turn out to really be colorectal cancer. Think about testing that hasn’t been completed due to the age of the patient or the extensiveness of the testing. By thoroughly investigating these options, we can unlock the answers needed to determine accurate diagnoses and effective treatments.

Searching for answers to health-related issues such as receiving a diagnosis after being undiagnosed or misdiagnosed can bring complicated feelings for patients. On one hand, there is relief because there is finally an answer – and hopefully a path for potential treatment. On the other hand, receiving a diagnosis can be distressing . If a participant finds out about a serious diagnosis, such as a rare disease or cancer during the screening process, it’s important to ensure social services are available to discuss further care options with the participant and process any feelings the participant is having.

While there are often additional barriers to identifying and engaging participants in undiagnosed populations, it is vital that these patients are not overlooked. Raising awareness around undiagnosed conditions can help Sponsors and sites better understand where participants are in their healthcare journey and respond with greater empathy, flexibility, and support. By considering financial burdens, prior healthcare experiences, unresolved symptoms, and general frustrations early in trial planning, study teams can put meaningful mitigations in place to support participants throughout their study journey.

Patient recruitment and retention remain some of the most challenging hurdles in clinical development. A well-vetted feasibility and recruitment strategy coupled with focused patient recruitment and retention teams sets Sponsors up for expedited enrollment and reduced patient dropouts. Medpace’s IntelliPACE ® model synthesizes data from both internal and external data sources to guide the selection of the best countries and sites for study participation. This data is further refined through Medpace expert analysis and input from sites and Key Opinion Leaders to align the target patient population with high-performing investigative sites.

Once the optimal strategy is defined, our specialized Patient Recruitment and Retention team steps in to execute the plan seamlessly and efficiently through our ExcelliPACE ® . Through this process we ensure that patients and caregivers are supported throughout their clinical trial experience by focusing on awareness and education; comfort and convenience; and providing technology to support participation.

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