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MedCity influencers, biopharmaceuticals, health technology
Precision medicine-personalized treatment for patients based on their genetic or molecular characteristics-is growing steadily in the medical world. After testing these treatments in clinical trials, doctors have seen success in using precision medicine to treat serious diseases such as depression, colon cancer, and leukemia.
But precision medicine is still far from being universally understood by patients. According to a 2020 survey, two-thirds of Americans have never heard of precision medicine, and only 11% have discussed precision medicine with their doctors.
If precision treatment often works, why do people who meet the conditions rarely accept it? One of the reasons is that clinical trials of precision treatment are often difficult to recruit enough participants. It is also difficult for primary care physicians to quickly and easily access the genetic data of patients and the list of trials their patients are eligible to participate in.
Decentralized clinical trials can help solve these two challenges. Technically supported trials allow researchers to search for eligible patients within a larger geographic area. Researchers can then use technology to safely share genetic data and information about precision treatments.
Decentralized clinical trials bring precision treatment to more patients
As I discussed in my article on rare disease trials, recruiting for trials that require participants with specific genetic characteristics is a challenge. 80% of clinical trials did not complete recruitment on time. Compared with other trials, the patient pool for precision medicine trials is usually smaller.
Decentralized clinical trials address this challenge in two ways. First, they allow researchers to reach patients across the country and even around the world. Sponsors based in Houston can use technology to establish connections with research locations in Seattle, Boston, or small towns in Georgia. They can then recruit patients from all these locations.
If patients live far away from big cities, they can still use technology or visit local clinics or pharmacies to participate in the trial.
Second, doctors and research sites can use decentralized testing techniques, such as patient recruitment software, to find trials that may be eligible to participate. With the patient's permission, this technology can match patients with tests suitable for their genetic or molecular characteristics.
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 indicated that they are willing to share their genetic information with the NIH database, many patients who should undergo genetic testing are unwilling.
For example, the National Comprehensive Cancer Network guidelines recommend genetic screening for breast and ovarian cancer for people whose family history puts them at risk. However, according to the 2020 study cited by Dr. Joel Diamond in a MedCity news article, only 50% of patients eligible for genetic screening due to their family history actually received these screenings.
Dr. Diamond also pointed out that some insurance companies only cover single genetic testing, not genetic panel testing. However, patients who carry a gene that puts them at risk of cancer may increase their risk of other inherited cancers.
In order to increase the speed of genetic screening and make precision medicine widely used, patient advocacy organizations, doctors, 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 expressed their willingness to participate in precision medicine trials. But 97% also said they had at least one barrier to participating in a clinical trial, and 76% said they had three or more barriers to participating.
Some reasons why people do not participate in the trial include:
Decentralized clinical trials cannot solve all these problems, but they can help solve some of them. They can allow patients to submit genetic information at home or from nearby clinics without having to spend hours traveling to academic medical centers.
Technology can also provide information about trials in an accessible way. Patients can read information at their own pace on a tablet or computer, and use large fonts or screen readers when needed. Patients can also search the user-friendly database to find trials they may be eligible to participate in.
One problem that technology cannot solve is that some people are reluctant to share their genetic data because they worry that the data will be used against them. They worry that insurance companies will charge them higher fees because they are at risk of a certain disease, or they may not want to have children.
This is why it is important for investigators, primary care physicians, insurance companies, and lawmakers to establish ethical standards around genetic data. With strong regulations to protect patients, genetic data will be used for pioneering medical care, not discrimination.
Doctors need easy access to data from precision medicine trials
Precision medicine clinical trials can only help patients if the doctor understands the latest treatment methods. Because primary care doctors treat so many patients a day, they must be able to find genetic information about patients and information about ongoing trials in one place.
However, the complete story of a patient's genetics, family history, and risk of certain diseases is usually distributed in multiple electronic health records (EHR). This means that doctors may not realize that patients need genetic screening or are eligible for specific precision medicine tests.
Most importantly, genetic screening and other test results are not always included in the EHR. Software systems need to be integrated with each other so that doctors can access genetic data, family history, and test results in one program. Doctors can use all this information to find the best treatment for each patient.
How to make the integration of precision medical data a reality
In order to ensure that doctors can access patient health information, we need to ensure that all systems containing patient health information-including electronic medical records from different health systems-can be integrated.
Doctors and clinical researchers should search for systems with open APIs. Open-API software can be integrated with any other software with open API.
The health system also needs to share genetic data outside of its buildings for research purposes. Genetic data can only be shared with the patient's permission. However, a database showing how certain genes affect health and which treatments are effective for people carrying these genes could make precision medical treatments more accessible.
Unleash the full potential of precision medicine clinical trials
Precision medicine clinical trials can help doctors find treatments that suit the needs of patients and improve the lives of patients with rare diseases, cancers and chronic diseases.
But in order for precision medicine to reach its full potential, clinical trials using precision treatments need to recruit enough patients with the correct genetic characteristics. This means using technology to reach patients who have historically been excluded from trials.
If clinical trials and the larger medical industry embrace these trends, integrated software, accessible genetic data, and advances in precision medicine can change the lives of millions of patients.
This webinar will explore how connected care solutions can help you establish a direct relationship with patients and provide them with a personalized experience that directly affects their perception of reporting treatment results.
Bill Martin, head of neuroscience global therapeutics at Johnson & Johnson's Janssen Pharmaceuticals, shared some promising developments in neuroscience, such as the rise of neuroimmunology and the industry's adoption of digital health tools to support the development of drug treatments in a recent interview.
Andrea Bastek is the innovation director of Florence, the platform is the largest eISF + remote site access platform in the clinical research field, connecting more than 8,000 research sites in 30 countries/regions. She has extensive experience in the field of clinical trials of medical devices, including in-depth cooperation with sites to promote the process of ensuring successful participation in research. She is dedicated to finding ways to improve the workflow efficiency of clinical trial execution. She has a doctorate degree. Doctor of Biomedical Engineering from Georgia Institute of Technology.
Decentralized clinical trials, precision medicine
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