Patient participation is the backbone of clinical trial research. Without broad representation, results may be skewed to a less representative patient population that cannot be extrapolated to the general public. Local clinical trial accessibility has been identified as a major challenge, with trials unavailable to 56% of eligible patients at their local institution and patients unable to travel to a site within a reasonable commute. Clinical trials for advanced cancers in particular have poor geographic accessibility for many in the United States due to long travel times. However, decentralized research has the potential to improve clinical trial access and pave the way for broader patient representation.
The Covid-19 pandemic highlighted the need to improve and accelerate easier, more accessible healthcare delivery, especially for underserved populations. Long-standing health inequities in social determinants of health – such as poverty and healthcare access – are interrelated and influence a downstream effect of health and quality-of-life risks. This demands more inclusive and accessible care. There is a need to integrate digital health technology tools into the healthcare system to ease the burden of clinical workload, improve patient care, and increase patient engagement. Digital health applications such as telemedicine, digital patient monitoring using wearables, and digital biomarkers can allow healthcare providers (HCPs) to improve care delivery and disease management while reducing unnecessary interventions.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Clinical trials, with their traditional in-person demands, are evolving as well. The pharmaceutical industry should be leading the development and implementation of decentralized clinical trials (DCTs) given their expertise in clinical research. By working and co-creating DCTs with large and small healthcare systems, this model would enable broader and easier access to patients who are interested in participating in clinical trials. The industry is working toward a greater ability to tie a patient’s perspective and clinical research with technology, while maintaining the highest legal, clinical, and regulatory standards.
Solutions crafted today may lay the groundwork for delivery of more personalized healthcare, offering end-to-end digital health solutions across the entire patient care continuum from screening to diagnosis, treatment, monitoring, and palliative care. In order to work meaningfully, the pharmaceutical industry cannot work alone. Pharma needs to begin with the end in mind, actively seeking patient and HCP perspectives through user acceptability testing and collaborating with technology companies to mold the products, software solutions, and clinical trial platforms together. The patient and HCP voices impact clinical workflow, and both are key gatekeepers of adoption. There needs to be data transparency, a process that incorporates the patient voice and journey from the inception of design.
Data standards and interoperability across multimodal digital health solutions are critical to ensure successful cross-pollination between industries. Also, industries must speak the same language with agreed-upon workflows and interfaces with which data is exchanged, while maintaining health privacy and security standards. Value and reimbursement from the payer perspective dictate real-world applicability, such as the Blue Button 2.0 for standards-based Application Programming Interface (API). Regulatory bodies must provide clarity using practical approaches that balance benefits and risk and therefore dictate the life-cycle of innovative digital health solutions. The pharmaceutical industry is well-equipped with the knowledge, communication, and influence to bring key stakeholders together.
Above all, the industry mindset must remain open and avoid conventional approaches. Digital health technology must address real-time social issues and continuously iterate to improve health equity. DCTs are an imperative and attainable step in the journey to improve greater clinical trial equity and access for patients. The journey is new and will be rewarding, and when the industry is able to prove value from the programs that were validated, with approval from the appropriate health authority, DCTs will change the paradigm from a nice-to-have to a must-have.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Anna Yang is a Medical Science Director in Digital Health Oncology at Genentech. She is passionate about leveraging healthcare and technology to increase value and continuity of care for all patients. Anna graduated from Rutgers University with a Doctorate of Pharmacy and completed a fellowship in U.S. Medical Affairs/Medical Science Liaison through the Rutgers Pharmaceutical Industry Fellowship Program.
Marianne Chacon-Araya is a medical doctor in clinical medicine and surgery from Costa Rica, with an MBA in Strategic Leadership from the London School of Business and extensive pharmaceutical industry and business experience across Latin America and the US. She currently leads an oncology cross portfolio team in Medical Affairs that is researching and piloting how to leverage digital technologies to improve patient care.
She is passionate about innovation, challenging the status quo to break boundaries to increase and personalize access to care for ALL patients.
Janet Moga is a Principal Medical Science Director in Oncology Digital Health in U.S. Medical Affairs at Genentech. She has more than 15 years’ experience in the pharmaceutical industry across a myriad of roles on both product development and medical affairs. For the last four years, she has been in digital health roles specific to incorporating digital health technologies into clinical practice and research initiatives. She actively collaborates with her U.S. and global colleagues on exploratory digital health programs in areas such as remote patient monitoring, decentralized clinical trials and digital biomarkers. Moga is the team lead for ensuring a seamless patient experience on a decentralized clinical trial with the Veterans Health Administration. Her motivation and drive come from the potential of digital health to truly change patients’ care and treatment journey for the better.
Victory Joseph is a Senior Medical Science Director in Digital Health Oncology at Genentech. She received her Ph.D. in Neuroscience from the University of California, San Diego and has since worked in a variety of roles in the pharmaceutical industry leveraging technology to expand medical research, accelerate the development of new therapies, and optimize healthcare delivery.
