The impact of genomics on the development of personalized medicine is only accelerating. Today, according to the American Society of Human Genetics (ASHG), nearly half of all NIH-funded research has a genomics component. In addition, more than 7,000 rare diseases exist, with fewer than 500 FDA-approved treatments at this time. Given that 80% of rare diseases are considered to have a genetic basis, the call for more gene-based therapies, and therefore genomics-based clinical trials, will continue to increase.

How does a clinical trial sponsor effectively enroll patients for genomics-based clinical trials? There are many obstacles that stand in the way of enrolling a diverse set of patients who meet the requirements of a clinical trial. These run the breadth of the trial timeline: From planning and feasibility to post-market planning and engagement.

Study sponsors and CROs often encounter roadblocks to patient recruitment, due to lack of access to patient-specific genetic data and difficulty engaging community physicians in clinical trial screening. Even when clinical trials are successful, sponsors continue to face challenges connecting to the rare disease community post-market and effectively negotiating payor coverage policies. Access to genetics specialists can address these problems and help to advance more gene-based therapeutics to market. Here’s a look at how.

Tackling trial planning and outreach

Pharmaceutical and biotech companies are passionate about personalized therapies in medicine. However, trial sponsors and CROs consistently struggle to find appropriate patients for these trials. In fact, the process can quickly overwhelm site personnel and derail study timelines. With genetic experts overseeing patient identification and trial engagement, sponsors can ensure trust-building with patients and support groups.

Clinical trials demonstrate more success when biomarker preselection is part of patient identification. As part of this process, a genetic counselor provides education to patients on the science behind the therapy or medicine, the trial itself, and the specific gene mutations the therapy targets, as well as answers to any questions a patient or their family, may have. Genetic counselors not only are able to aptly identify patients with relevant genetic mutations, but they are also able to mitigate additional barriers to patient participation and engage patients and families in the process. In one study, applying a genetic counselor model to the patient recruitment process identified more than seven times (7X) the number of eligible patients identified over that of the sponsor’s highest performing site.

Sometimes, word of a promising advancement and trial may spur interest from patients, who will commonly either reach out to their own community physician or directly to a clinical trial site. Unfortunately, community-level providers are usually unfamiliar with study specifics and don’t order genetic testing as part of their practice. Conversely, clinical trial sites are often overwhelmed and can’t triage interest from unqualified patients in a timely manner.  This can be the start of distrust or lack of engagement between the patient community and the study. In contrast, telemedicine genetic counseling services build trust by educating the patient and family with highly personalized information and providing study pre-screening in the patient’s home.

Leveraging technology, telemedicine

Working with telemedicine-based genetics experts provides families with more convenient access to genetic testing, genetic counseling, and clinical trial screening. Telemedicine services also enable trials to reach remote and underserved communities and increase the diversity of research participants.

Leveraging technology isn’t just about Zoom meetings; patient privacy is critical. For clinical trials, once a gene-positive patient consents to a referral to the clinical trial site team, private, secure introductions and transfer of necessary files through secure electronic health records (EHR) systems from a genetics provider partner continue that high-touch experience where the patient and family feel heard and valued. When working with one of our clients on a clinical trial in a genetic subtype of dementia, a patient-centric approach supported by technology resulted in 95% of eligible, gene-positive patients agreeing to engage with the clinical trial.

Test result interpretation

Genetic test result discussions are highly impactful for patients and their families. Genetic experts are specifically trained to help patients understand genetic test results in a way that is both meaningful and in the context of a patient’s personal and family history. In addition, downstream implications to family members bring forth questions about who else in the family might benefit from testing and what type of test may be recommended. Clinical genetics experts are well versed in these nuances to effectively help patients navigate these next steps.

Even if a patient is not found to have the specific gene mutation of interest for the clinical trial, they still benefit from the information provided through genetic counseling. These new insights can enhance the patient’s current treatment and management. Patients also benefit from this positive interaction with an expert in their condition, and will be even more informed and ready to engage down the road should a promising therapeutic arise for their situation. At the same time, sponsors can also be certain that anyone referred to them is truly eligible, ensuring the highest potential for successful enrollment.

After the trial

With a successful trial moving towards a post-market phase, genetic experts continue to add value. Their expertise can be effectively utilized for FDA review and payor education about available genotype-phenotype data and necessary updates to coverage policies. At InformedDNA, we have strong relationships with regional and national health plans that pave the way for collaborative policy negotiations. While there are many challenges to overcome in bringing gene-based therapies to market, harnessing the expertise of genetics specialists in genomics-based clinical trials can drive success and maximize the potential of personalized medicine. Genetic counselors are the necessary partner for sponsors, CROs, patients, and their families to maintain progress through clinical trial phases through post-market planning and community engagement, with the unifying goal to serve patients who have hereditary.. diseases that can benefit most from the development and availability of these novel therapies.

InformedDNA’s role

Founded in 2007, InformedDNA is the leading applied genomics solutions company. With the largest, lab-independent, full-time staff of board-certified genetics specialists in the U.S., InformedDNA helps to ensure that pharmaceutical and biotech companies, health plans, hospitals, employers, clinicians, and patients all have access to the highest quality genetic services.

Key offerings for pharmaceutical and biotech companies include support for clinical trial design, patient engagement and recruitment; physician education and engagement; clinical genetic counseling; and, test ordering and interpretation services. Learn more about our solutions for sponsors and CROs – just submit the short form below. Or, if you’re ready to chat, email us at pharma@informeddna.com or call us at 844-846-3763.

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