Precision medicine allows us to precisely match the right treatment to the right patient. It’s a tremendous advance. Except: The more precisely we target the therapy to the patient, the more difficult it becomes to find patients for clinical trials.

For example, for a variant that is only found in one to two percent of the population, upwards of 15,000 patients will need to be screened to find 300 who are eligible.

That can be frustrating, especially in an environment where 20-25 percent of all clinical studies close because they don’t meet enrollment targets.[i] As research increasingly focuses on highly targeted patient sub-populations, the competition for patients will only grow fiercer.

So, how do sponsors find, engage and ultimately enroll participants who have a genetic variant?

The answer: They work with genetics experts who have direct patient care experience. We’ve seen firsthand how this can help sponsors improve patient identification, recruitment and retention.

Like genetic testing, genetic counseling and interpretation are essential to the clinical development of genetic-based therapies. But many sponsors and CROs lack the expertise to appropriately integrate genetics into their studies, and many researchers assume that adding a genetic component to their trial involves little more than adding a genetic test to the protocol.

Some sponsors hire genetic consultants for study design, but they may lack the deep clinical trial expertise to understand the intricacies of both patient care and clinical trials.

Genetic counselors are the key to unlocking patient engagement. Here are five examples:

1) Providers as the gateway to patient engagement

To engage patients, we must engage clinicians. However, many clinicians feel ill-equipped to interpret and communicate genetic test results to their patients. They may not even want to know the results because they don’t believe they can successfully manage patient and family expectations. Then there’s the challenge of simply managing all the patient data points that genetic testing creates. It can be daunting for the clinician and the site. Bringing in a genetic counselor relieves that burden.

For example, through our partnership with InformedDNA and the creation of the Center for Precision Medicine and Genetics, we can provide guidance to physicians who want to discuss the results with their patients, or their counselors can talk with the patients themselves. Offering genetic counseling and genetic test interpretation services to patients and providers increases patient and provider satisfaction. (InformedDNA reports 93.3 percent provider satisfaction and 95.5 percent patient satisfaction. And we all know that patient satisfaction drives engagement and retention.)

2) Engagement through education:

Genetic information can be confusing. When counselors spend time discussing the results with the patient, the patient better understands the implications of their results. Counselors also help control expectations so participants don’t have unrealistic hopes.

Merely handing the patient a printout of the results isn’t going to cut it: Patients need expert guidance and education to help them understand what the test results mean and how they will potentially affect them and their families. Genetic counselors provide this level of connection, and by virtue of that connection, they can also open a pathway to finding more subjects for the trial through family members–no matter where they live. 

3) Engagement across borders:

Patients with rare diseases or rare mutations aren’t conveniently clustered near major academic medical centers. They are scattered around the world. Sponsors need to reach those patients to screen them locally, and then refer those who meet genetic inclusion criteria to a study site. By providing virtual genetic counseling to trial candidates, InformedDNA helps eliminate geographic barriers. Community physicians can administer the test in their offices anywhere, reducing screening time and patient burden.

4) Engagement for the future:

Whether they are included in the clinical trial or not, patients are learning new information about themselves that could have an impact on how they live the rest of their lives. How well–or poorly–this is handled can have a profound influence on the willingness of a patient to participate in current or future trials. These patients could be more informed and engaged volunteers for future trials, or they could become so frustrated that they didn’t qualify and be ill-disposed to being tested for another trial. A genetic counselor can make the difference by discussing their options with them and helping them source clinical trials for potential future participation.

5) Engaging through the advocates:

Patients with rare diseases often feel isolated and frustrated, and seek out groups of others with the same condition. The same holds true for parents of children with rare diseases. Sponsors routinely work with these groups, but they can up their game by providing genetic counselors. This increases the pool of potential study participants, creates good will and gives patients and families access to valuable resources, such as our partner,

Beyond better trials

We all understand that better patient engagement means better trials but, increasingly, regulatory agencies are asking for patient-reported outcomes and patient stories. Engaging patients from the outset makes gathering and compiling this much easier.

And then there’s the recent recommendation from the National Academies of Science, Engineering, and Medicine that investigators share more data with clinical trial participants. But providing information–especially genetic information–to participants who may not know how to understand or interpret it could do more harm than good. As we’ve discussed, a genetic counselor can help a patient understand the results and make informed decisions.

If your trial has a genetic component, you probably need to consider adding a genetic counselor. Deployed correctly, counselors can help you create a pool of informed, engaged volunteers, enhancing enrollment and retention. That can reduce time, frustration and cost.

If you’re ready, we can help.

At WCG, we have a proven record of driving study enrollment in rare-disease and hard-to-reach populations. Our partner InformedDNA provides genetic counselors and maintains a global network of genetic datasets that facilitate the rapid identification of patients with unique or rare conditions. Together, we’re helping sponsors, CROs, institutions and sites identify hard-to-find patient populations, reduce their exposure to risk, identify broader indication applications and increase the overall value of the therapy being studied.

To learn more, visit our Center for Genetics and Precision Medicine in Clinical Trials.


[i] WCG proprietary Knowledge Base