An innovative way to conduct genomics research is underway to transition some omics-related studies out of hospitals, labs, and clinics to take them directly to people in their homes and communities. At Mayo Clinic's Center for Individualized Medicine, clinical trial study staff, including coordinators, physicians and scientists, are working hard to increase trial access for people in rural communities and underrepresented racial and ethnic minority populations.
Clinical trials are studies that examine the effectiveness of drugs or medical devices, and guide physicians in treating patients. A recent study shows the lack of diversity has hindered the understanding of genomic links to diseases and exacerbated health disparities. The goal of the new patient-centered omics clinical trials model is to close the disparities gap and improve health outcomes for more patients.
"This new effort could help us guide the development of more impactful clinical interventions for everyone," says Tufia Haddad, M.D., a medical oncologist, with a specialty interest in precision medicine in breast cancer. Dr. Haddad also serves as a leader for Mayo Clinic's digital strategy in clinical trials.
Omics is an emerging multidisciplinary field of biological sciences that encompasses genomics, proteomics, exposomics, epigenomics, transcriptomics, metabolomics and more. Omics research holds transformative possibilities for predicting and diagnosing diseases, such as cancer, and devising individualized treatments tailored to a person's unique biological characteristics.
This new era of direct-to-patient omics clinical trials is built on a foundation of collaborations with local communities, including local health systems and nontraditional sites, like churches or retail centers.
Thanks to advances in medical tools and technologies, some of the at-home clinical trial processes may include administering experimental therapies, collecting biospecimen samples, conducting mobile imaging, completing electronic survey questionnaires, participating in telehealth video visits and using special medical monitoring devices.
Dr. Haddad says clinical trials are resulting in new targeted therapies and immunotherapies for cancer care at a rate never seen before. She says this effort could help further accelerate medical discoveries for disease diagnoses and treatments.
"The number of newly approved oncology drugs, or new indications for a drug, used to be about 10 per year back in the early 2000s. But now that pace is averaging about one per week," Dr. Haddad says. "It's a hopeful time for cancer research."
Dr. Haddad says her inspiration to become an oncologist and her devotion to helping patients comes from her mother, who was a gastrointestinal researcher at Mayo Clinic.
"I had a lot of exposure to the laboratory growing up, so I've always had a passion for research. But when I was 17 years old, I lost my mom to metastatic breast cancer," Dr. Haddad says. "She was very proud to participate in clinical trials. So that experience has really allowed me to be effective in my role, not just as a practitioner and treating oncologist, but also really trying to champion clinical trials access for all patients."
The 12th annual Mayo Clinic Individualizing Medicine Conference, called "Direct-to-Patient Omics-Based Clinical Trials" on May 5-6, 2023, in Ponte Vedra, Florida, will bring together some of the world's top scientists, clinicians and thought leaders to share the latest omics and data-driven analytical technologies and research.
"The landscape of medicine is changing," says Konstantinos Lazaridis, M.D., the Carlson and Nelson Endowed Executive Director for Mayo Clinic's Center for Individualized Medicine. "What we thought clinical studies and trials were five years ago is no longer the case. Direct-to-patient omics-based clinical studies are increasing access, leveraging minority engagement, decreasing costs, and ultimately improving patient care. Omics education for providers will update those at the front lines of health care on the most state-of-the-art knowledge in the field."
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