The increase in access to therapeutics directly to patients through online compounding pharmacies and other direct-to-patient sales models has raised the likelihood of patients using medications alongside other treatments and with various complex co-morbidities.
The growth of GLP-1 drugs and the availability of direct-to-patient prescribing options position this drug category to utilize real-world data to showcase benefits for patients in therapeutic areas beyond current approvals in obesity and diabetes. While GLP-1 drugs present an opportunity for real-world study and surveillance, all new drugs and pharmaceutical categories can benefit from continuous post-market surveillance and observational research to identify opportunities for label extension and new patient groups that may not have been initially studied in clinical trials.
With the increase in availability of real-world data, most new drug applications to the U.S. Food and Drug Administration (FDA) now incorporate real-world data. This shift is partly due to the 21st Century Cures Act, which mandates the FDA to consider real-world data in support of new drug indications and label extensions.
Policymakers, regulatory leaders, and clinical development executives should explore new methods for healthcare stakeholders to gain insight into new drug classes to understand their risks and efficacy when used in real-world settings. Engaging in data sharing, observational cohort research, and in-depth analysis of existing data can lead to improved outcomes for patients, making label and cohort extension more efficient and comprehensive.
Enhanced data sharing among providers will ensure that all prescribers have the most current information on a patient’s health status.
The fragmented nature of patient data sharing in the American healthcare system presents a significant challenge to prescribers, who often lack visibility into additional medications used by a patient. This lack of information can lead to potential risks and adverse events. Healthcare provider capabilities, such as medicine reconciliation and health information exchanges, can enhance transparency among prescribers and provide insights into off-label use of therapeutics, adverse events, and the evolving safety and efficacy profile of specific medications.
Direct-to-patient access channels should utilize data sharing technologies to access more comprehensive health information about patients. Collaboration with electronic health record companies or healthcare provider organizations can also provide a more thorough understanding of a patient’s health status and prescription history.
Observational research can offer new insights into drug interaction risks and benefits not previously understood in real-world use. Observational studies of co-therapeutic drug use can provide information on potential risks under conditions that may be unethical for randomization.
Real-world data offers opportunities for clinical development executives and regulators to conduct deeper and more innovative analyses. The proliferation of consumer and patient-reported data platforms can further enhance these analyses by encouraging consumers to report their health behaviors and track their outcomes digitally.
In addition to expanding access to effective and safe medicines for new indications and patient populations, real-world data can improve diagnostics to ensure patients receive appropriate treatment based on their healthcare data. Personalized medicine can also be facilitated through the development of diagnostic tools that collect patient health histories, genetic information, and lifestyle data. En combinación con el aprendizaje automático y la inteligencia artificial, los algoritmos de diagnóstico pueden ser refinados para apoyar a los pacientes y proveedores de atención médica a hacer diagnósticos más tempranos y precisos, generando datos esenciales para expandir el uso de terapéuticos aprobados en nuevas cohortes de pacientes o indicaciones de salud.
La investigación clínica y observacional puede ser una herramienta valiosa para demostrar los riesgos y beneficios asociados con el uso de medicamentos en diversos grupos de pacientes y para identificar oportunidades de extensión de etiquetas. Al implementar un intercambio de datos sólido, los actores del sistema de salud pueden entender mejor cómo se utilizan los productos emergentes en el mundo real. Mejorar el acceso de los pacientes a terapéuticos a través de canales directos al paciente aumentará la disponibilidad de tratamiento y puede ofrecer nuevas oportunidades para recopilar datos sobre el uso del mundo real de terapéuticos novedosos. A medida que el uso de GLP-1 se expande, los datos del mundo real pueden respaldar la extensión de la etiqueta a enfermedades cardiovasculares y otras indicaciones, incluidas enfermedades neurodegenerativas, SOP, enfermedad renal crónica y otras. Con más datos, las organizaciones farmacéuticas pueden mejorar los protocolos de diagnóstico, mejorar la personalización de los planes de tratamiento y comprender mejor los posibles riesgos e indicadores de seguridad. La investigación observacional rigurosa y el intercambio de datos entre los actores de la salud pueden respaldar el uso seguro y eficaz de todas las nuevas categorías de medicamentos.
Nota del editor: El autor no tiene relación con ninguna de las empresas/productos mencionados.
Foto: Yuichiro Chino, Getty Images
Jenna Phillips es una experta en salud y ciencias de la vida en PA Consulting. Jenna trabaja con clientes en las industrias de la salud, ciencias de la vida y bienes de consumo. Su enfoque es apoyar a las organizaciones para llevar nuevas ofertas de productos y servicios al mercado que generen valor para los clientes, pacientes, consumidores y otros interesados. Jenna tiene una Maestría en Salud Pública de la Escuela de Salud Pública T.H. Chan de Harvard.
Esta publicación aparece a través del programa MedCity Influencers. Cualquiera puede publicar su perspectiva sobre negocios e innovación en el cuidado de la salud en MedCity News a través de MedCity Influencers. Haz clic aquí para descubrir cómo.