The COVID-19 pandemic has created significant challenges for clinical trials. For studies focused on rare diseases, these challenges are compounded by the obstacles of finding, recruiting, and retaining patients with rare conditions, and navigating complex regulations and guidelines in the use of genetic data.
Although genetic testing can identify eligible patients, the use of these tests raises issues including informed consent; use and disclosure of genetic test results; the lack of genetic literacy in the patient population and among staff at trial sites; and insufficient time for providers to review complex findings. Combined with the additional challenges that COVID-19 poses, continuing trials during this time is a difficult task. Despite these obstacles, it is both essential and possible to keep rare disease clinical trials moving forward safely.
Going Directly to Patients
Direct-to-patient outreach can be a powerful tool to reach potential patients safely during this difficult time by enabling them to participate in a trial from their homes. Solutions such as shipping test kits directly to patient homes support patient participation while traveling to a trial site is neither safe nor feasible, especially for rare disease patients at higher risk of severe illness from COVID-19. Another solution is obtaining informed consent digitally from patients, enabling data transfer from lab to sponsor. At InformedDNA, we also provide robust clinical data for genotype/phenotype analysis by reviewing medical records and obtaining additional medical and family history from patients, further reducing the time patients need to spend in a clinic.
To expand reach further, it’s advisable to partner with advocacy groups for genetic testing initiatives. One solution to engage these groups is to join social media and online forums to share clinical research information. By providing resources and education to patients and nurturing relationships with past participants, you can access the maximum genetic data that meets national guidelines and recommendations for collection, use, and reporting, even if it’s not being collected in person.
Leveraging Telemedicine for Remote Screening
As there is continued concern with in-person meetings, many patients and physicians have turned to telemedicine to address non-critical conditions. Using remote capabilities has proven effective across many trial activities from increasing patient participation to decreasing cost by reducing on-site evaluations, including patient screening. Using a telemedicine platform to reach out to patients is an increasingly common solution employed prior to site referral.
Genetic experts who specialize in guiding patients and healthcare providers (HCPs) should also be utilized to gather remote consent for genetic screening and to provide pre- and post-test genetic counseling about the test, disease, and the science of the clinical trial. Remote genetic screening programs can also be useful in reaching people of diverse geographic and socioeconomic status, as well as diverse racial and age populations, by locating potential candidates in their own communities.
Guiding Medical Management
Specialized rare disease expertise is critical to building patient rapport and trust. Effective patient education is proven to increase study interest and participation. Expert guidance is needed to help patients make informed decisions about their treatment.
Deep knowledge of a specific rare disease enables genetic counselors to advise both patients and their HCPs regarding medical management and available clinical research options. In our experience, more than half of all physicians choosing to participate in a sponsored screening program report that they would not have participated without our specialty-level genetic counseling expertise.
Navigating Test Results
Genetic testing is often critical for the appropriate identification of patients as clinical trial candidates for rare disease studies, but most physicians lack the time and the training to interpret complex genetic test results and provide counseling to patients. Implementing a telehealth genetic counseling program can ensure that screened patients receive consistent information at their level of understanding. Board-certified genetic counselors are trained to not only help patients navigate test results, but also advise healthcare providers. Incorporating clinical genetic experts who are well versed in contributing to rare disease medical management ensures that patients and HCPs receive a clear picture of their available medical management options, including current therapy and clinical trials.
This not only helps sponsors build trusted relationships with patients and their HCPs, but also that ensures patients feel supported when navigating test results, helping them remain engaged throughout the entire process.
Genetic testing has the power to identify many eligible patients for trial participation. As the pandemic evolves, researchers will need to continue safeguarding patients. InformedDNA can help navigate these new challenges, as well as more traditional obstacles, to keep your trial moving forward safely.
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