Precision medicine—treatment personalized for a patient based on their genetic or molecular profile—has steadily grown in popularity in the medical community. Physicians have seen success using precision medicine for serious illnesses like depression, colon cancer, and leukemia after testing those treatments during clinical trials.
But precision medicine is still far from universally understood by patients. A 2020 survey showed that two-thirds of Americans had never heard of precision medicine, and only 11% had discussed precision medicine treatments with their doctors.
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If precision treatments often work, why have so few eligible people received them? One reason is that clinical trials for precision treatments often have trouble recruiting enough participants. Primary care physicians also struggle with gaining quick, easy access to their patients’ genetic data and to listings of which trials their patients are eligible for.
Decentralized clinical trials can help with both of these challenges. Tech-enabled trials allow investigators to search for eligible patients over a larger geographic area. Investigators can then use technology to share genetic data and information about precision treatments securely.
Decentralized clinical trials bring precision treatments to more patients
As I discussed in my article on rare disease trials, recruitment is a challenge for trials that need participants with specific genetic profiles. 80% of clinical trials don’t finish recruitment on time, and precision medicine trials often have smaller patient pools to draw from than other trials do.
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Decentralized clinical trials address this challenge in two ways. First, they let investigators reach patients across the country or even the world. A sponsor located in Houston can use technology to connect with research sites in Seattle, Boston, or small-town Georgia. They can then recruit patients from all of those locations.
If patients live far away from a major city, they can still participate in the trial using technology or visits to their local clinic or pharmacy.
Second, physicians and research sites can use decentralized trial technology, like patient recruitment software, to find trials patients may be eligible for. With patients’ permission, this tech can match patients with trials suited for their genetic or molecular profile.
But for patient recruitment software to work, the healthcare industry needs to make genetic testing widely available and affordable.
Genetic testing must become commonplace
Although 79% of patients said they would be willing to share their genetic information with an NIH database, many patients who should receive genetic testing don’t.
For example, National Comprehensive Cancer Network guidelines recommend genetic screening for breast and ovarian cancer in people whose family history puts them at risk. But according to a 2020 study referenced in a MedCity News article by Dr. Joel Diamond, only 50% of patients who qualify for genetic screening because of their family history actually receive those screenings.
Dr. Diamond also points out that some insurance companies only cover single-gene testing, not gene panel testing. However, patients carrying one gene that puts them at risk for cancer may have an increased risk for other genetic cancers.
To increase the rate of genetic screening and make precision medicine widely available, patient advocacy organizations, physicians, laboratories, and insurance companies must work together to encourage genetic testing and make it affordable.
Precision medicine trials must be accessible
89% of people with disabilities said they would be willing to participate in precision medicine trials. But 97% also said there was at least one barrier to their participation in clinical trials, and 76% said there were three or more barriers to their participation.
Some of the reasons people gave for not participating in trials included:
- Healthcare facilities weren’t accessible
- Transportation to healthcare facilities was difficult or expensive
- Communicating with healthcare professions was challenging
- Information about medical research was hard to find or access
- Genetic profiles might be used to discriminate against people with disabilities or chronic illnesses
Decentralized clinical trials can’t solve all of these problems, but they can help with some of them. They can allow patients to submit genetic information from home or from clinics in their neighborhood instead of traveling for hours to reach academic medical centers.
Technology can also provide information about the trial in accessible ways. Patients can read the information at their own pace on a tablet or computer and use large font or screen readers if needed. Patients can also search user-friendly databases to find trials they might be eligible for.
One problem technology can’t solve: some people hesitate to share their genetic data because they worry it can be used against them. They fear insurance companies could charge them more because they are at risk for a certain illness or that they could be discouraged from having children.
That’s why it’s important that investigators, primary-care physicians, insurance companies, and legislators establish ethical standards around genetic data. With strong regulations to protect patients, genetic data will be used for groundbreaking medical treatments, not discrimination.
Physicians need easy access to data from precision medicine trials
Precision medicine clinical trials can only help patients if doctors are aware of the latest treatments. Because primary-care physicians treat so many patients in a day, it’s essential that they can look in one place for a patient’s genetic information and information about ongoing trials.
But the full story of a patient’s genetics, family history, and risk of certain diseases is often spread across multiple electronic health records (EHRs). This means doctors may not realize a patient needs genetic screening or is eligible for a specific precision medicine trial.
On top of this, genetic screenings and other test results aren’t always included in the EHR. Software systems need to integrate with one another so that doctors can access genetic data, family history, and test results within one program. Physicians can use all of that information to find the best treatment for each patient.
How to make integrated precision medicine data a reality
To ensure physicians can access patients’ health information, we need to make sure all systems that contain patient health information—including electronic medical records from different health systems—can integrate.
Physicians and clinical researchers should search for systems with an open API. Open-API software can integrate with any other software that also has an open API.
Health systems will also need to share genetic data outside of their buildings to enable research. Genetic data should only be shared with patients’ permission. But a database that shows how certain genes impact health and what treatments will work for people with those genes could make precision medicine treatments more accessible.
Unlocking the full potential of precision medicine clinical trials
Precision medicine clinical trials can help physicians find treatments customized to their patients’ needs, improving the lives of patients with rare diseases, cancer, and chronic illnesses.
But for precision medicine to reach its full potential, clinical trials using precision treatments need to recruit enough patients with the correct genetic profile. That means using technology to reach patients who have historically been excluded from trials.
Integrated software, accessible genetic data, and advances in precision medicine can transform the lives of millions of patients–if the clinical trial and larger medical industry embrace these trends.
Photo: Warchi, Getty Images
Andrea Bastek is the Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research with more than 8,000 study sites across 30 countries connected. She has extensive experience in the clinical trials space for medical devices, including deep collaboration with sites to drive processes that ensure successful study participation. She is committed to finding workflow efficiencies that improve clinical trial execution. She holds a Ph.D. in Biomedical Engineering from the Georgia Institute of Technology.
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