Spectrum Clinical Research: A Clinical Trial Enrollment Case Study
We recently interviewed Jovanna Schlossenberg - founder & site director of Spectrum Clinical Research - about her experience in bringing patients into her clinical research environment.
Clinical trial recruitment is one of the most challenging, undeveloped parts of running a clinical trial. Particularly with privately owned research sites, the community outreach, networking relationships, and overall exposure are huge barriers to research because without successful participation, trials and research can't move forward.
Who Is Spectrum Clinical Research?
Spectrum Clinical Research is a clinical trial research site based in Kansas City, MO. Spectrum Clinical is currently sponsored to conduct research in Asthma and Hypothyroidism, with plans to expand to diabetes, neurology, and more in the future.
Spectrum Clinical Trial Recruitment
As with most sites we work with at Third Opinion, Spectrum Clinical is left on their own to fulfill their research studies. The clinical trial industry has a large disconnect in bridging patients interested in novel research to the folks conducting said novel research - and Spectrum Clinical is a great example.
Jovanna is ambitious and driven to move research forward with Spectrum Clinical, but clinical trial recruitment is often a bottleneck to achieving her goals. That being said, Jovanna does everything she can to increase exposure and community relationships including her motto of "Applying 7 forms of connecting" to her community consisting of community events, digital marketing, clinic networking, and more.
Barriers To Clinical Trial Enrollment
Our discussion with Jovanna quickly turned towards the steps and constricting barriers between 1) initial contact with an interested patient, and 2) successful enrollment into a research study. The main barriers we discussed were patient engagement, inclusion/exclusion criteria, obtaining health records, scheduling, and randomization. Each barrier is a non-negotiable step in qualifying a patient for a research study, and at each barrier a handful of interested participants drop off.
Patient Engagement: Particularly with online marketing, it can be intimidating for patients to take the leap between clicking on an interesting study and talking through specifics with a recruitment coordinator. It helps to engage and listen to patients frequently to ensure transparency and maintain interest, or else the path of least resistance is often for patients to drop out.
Inclusion/Exclusion Criteria: Each study comes with its list of criteria that you must meet (inclusion) and critieria that you must not meet (exclusion). This is to ensure consistency of treatment and to be able to isolate the effects of said treatment the best way possible. The issue this generates in research recruitment is that some criteria can be restrictive and prevent interested patients from enrolling. Some common inclusion/exclusion criteria include BMI range, age, gender, preexisting health conditions, smoking, and other health markers.
Obtaining Health Records: To ensure the inclusion/exclusion criteria are met, clinical research sites often have to obtain patient medical records as the source of truth. Inclusion/exclusion criteria can be quite complex, and more often than not patients do not know whether or not they meet criteria. Obtaining health records (outside of using Third Opinion) involves calling a clinic, navigating through an answering machine and personnel, submitting a ROI, and waiting potentially weeks for a fax of the EHR (electronic health records) to be sent to your research site. After receiving the fax, a healthcare professional sifts through dozens of pages to determine trial eligibility. *Third Opinion designed an EHR integration tool to eliminate this step for patients and researchers - contact us here to learn more.
Scheduling: If the patient is still interested and qualified up to this point, the next step is to book a time to come in and schedule. This is a barrier because it is when trial participation becomes real, and the details of the study come out. Patients can drop out at this step due to travel time, clinic hours, or any study requirements (blood draw, no eating, time, etc.).
Randomization: This final step is dependent on the Phase and type of study being conducted. Randomization means when it comes time to get the treatment you might end up with a placebo. This is an essential step in a clinical trial because blind efficacy is the standard of proving a treatment works, but to a participant it can be undesirable. It is important to remind the patient that although they may not be receiving treatment today, their participation moves research forward so someone tomorrow can.
The Future Of Spectrum Clinical & Research Recruitment
Third Opinion and Spectrum Clinical Research are at the forefront of the next chapter of clinical research. Jovanna mentioned clinical research is becoming less centralized and more virtual, as shown by Spectrum Clinical's asthma study being run remotely across the United States. In addition, clinical research is becoming more transparent and patient-centric, focusing on making sure research participants are taken care of every step of the way.
Our mission at Third Opinion is to democratize clinical research and make research opportunities more accessible to all. We accomplish this with our software tools that connect patients to clinical trials, proactively match to inclusion/exclusion criteria, and communicate with patients every step of the way. Learn more about Third Opinion or find a clinical trial for you or a loved one today!
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