Working together to deliver stratified medicine research effectively

Abstract

Introduction or background Stratified medicine is an important area of research across all clinical specialties, with far reaching impact in many spheres. Despite recently formulated global policy and research programmes, major challenges for delivering stratified medicine studies persist. Across the globe, clinical research infrastructures have been set up to facilitate high quality clinical research. Sources of data This article reviews the literature and summarises views collated from a workshop held by the UK Pharmacogenetics and Stratified Medicine Network and the NIHR Clinical Research Network in November 2016. Areas of agreement Stratified medicine is an important area of clinical research and health policy, benefitting from substantial international, cross-sector investment and has the potential to transform patient care. However there are significant challenges to the delivery of stratified medicine studies. Areas of controversy Complex methodology and lack of consistency of definition and agreement on key approaches to the design, regulation and delivery of research contribute to these challenges and would benefit from greater focus. Growing points Effective partnership and development of consistent approaches to the key factors relating to stratified medicine research is required to help overcome these challenges. Areas timely for developing research This paper examines the critical contribution clinical research networks can make to the delivery of national (and international) initiatives in the field of stratified medicine. Importantly, it examines the position of clinical research in stratified medicine at a time when pressures on the clinical and social services are mounting.

Development of a model to demonstrate the impact of National Institute of Health and Care Excellence cost‐effectiveness assessment on health utility for targeted medicines

“…All three solutions achieve an identical compromise in the positioning of the line of alignment when the region of disagreement falls entirely within the area of  C  0 , for a particular value of E u . Our research builds on existing literature which has considered the challenges surrounding stratified therapies (ABPI, 2014;Wilsdon et al, 2018) and recommends collaboration between stakeholders (Attar et al, 2019;Cope et al, 2018).…”

Primary care genomic research: One eye on the future

“…The report recommended that the NIHR CRN develop specific training addressing these issues around genomic research and that study-specific educational material would help deliver genomic studies moving forward. This would build on the excellent work already undertaken by the NIHR CRN in the wider context of stratified medicine studies and resources developed to underpin that initiative (Attar et al., 2019).…”

Estrategias de implementación de la medicina personalizada de precisión en otros sistemas sanitarios públicos internacionales. Estado del arte.

“…2 y la Precision Medicine Initiative (PMI) 3 , la medicina de precisión se define como un enfoque emergente para el tratamiento y prevención de las enfermedades que conlleva una adaptación a las características individuales de cada paciente. Sin embargo, en esta definición se incluye además la capacidad de clasificar a los pacientes en subpoblaciones basada en perfiles complejos y multimodales que utilizan datos biológicos (ciencias ómicas), clínicos, de imagen, ambientales (microbioma, exposoma) y datos de dispositivos (sensores portátiles y datos sobre el estilo de vida) 4,5 . Esto es lo que se conoce como medicina estratificada, ya que permite aplicar intervenciones preventivas o terapéuticas en aquellos grupos de pacientes con características en común que obtendrán un beneficio de estas, evitando el gasto innecesario y posibles efectos secundarios a aquellos que no lo obtendrán 4 .…”