Precision public health is an emerging practice to more granularly predict and understand public health risks and customize treatments for more specific and homogeneous subpopulations, often using new data, technologies, and methods. Big data is one element that has consistently helped to achieve these goals, through its ability to deliver to practitioners a volume and variety of structured or unstructured data not previously possible. Big data has enabled more widespread and specific research and trials of stratifying and segmenting populations at risk for a variety of health problems. Examples of success using big data are surveyed in surveillance and signal detection, predicting future risk, targeted interventions, and understanding disease. Using novel big data or big data approaches has risks that remain to be resolved. The continued growth in volume and variety of available data, decreased costs of data capture, and emerging computational methods mean big data success will likely be a required pillar of precision public health into the future. This review article aims to identify the precision public health use cases where big data has added value, identify classes of value that big data may bring, and outline the risks inherent in using big data in precision public health efforts.
It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups. We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.
El perfil de políticas destinatarias (TpoP, por sus siglas en inglés) es una herramienta para facilitar el diálogo en torno a la evidencia necesaria para efectuar un cambio en la política. Se pretende articular claramente el cambio de política propuesto, las pruebas existentes para apoyar el cambio, las brechas en las pruebas y la naturaleza de las pruebas necesarias para llenar esas brechas. Es una herramienta para ayudar a decidir sobre la puesta en marcha de una investigación, así como para revisar los estudios recientemente propuestos en el contexto de los objetivos generales del programa. El TPoP también se utilizará para describir el proceso y el cronograma para la participación de las políticas a lo largo del ciclo de vida de desarrollo del cambio de política propuesto. Como resultado, el TPoP servirá como punto focal para el diálogo y la alineación entre las partes interesadas clave en el proceso de generación de políticas, facilitando el diálogo temprano y sustantivo.
The Target Policy Profile (TPoP) is a tool to aid discussion on the evidence needed to change or establish a new policy. This policy could be at the country, regional, or global level. The TPoP should state the proposed policy, the supporting evidence, gaps in the evidence, and the nature of evidence required to fill these gaps. The TPoP should serve as a framework for dialogue and alignment between key stakeholders in the policy development process. By laying out a roadmap to intended policy impact, this tool can also support funding decisions for a particular research agenda.
In many cases, the end goal of clinical research is a change in policy, but there is often a gap between the research and policy sides, which can lead to wasted money and time. To address this, the Target Policy Profile (TPoP) has been developed for use both prior to research to identify key research questions to support policy decisions and at the point of evidence generation and dissemination. It is envisaged that the TPoP could help researchers analyze the evidence underlying a given policy, the gaps in that evidence, and the nature of additional evidence needed to improve the policy. Furthermore, it aims to facilitate early and ongoing communication between researchers and policymakers. Armed with this knowledge and these relationships, clinical researchers can maximize the likelihood that studies meet the requirements to generate optimal policies in an efficient way.
Many clinical trials end uninformatively. Informativeness, in the context of clinical trials, defines whether a study’s results definitively answer its research questions with meaningful next steps. One subset of these trials are those focused on global health set in low-resource settings. Global health clinical trials benefitting people in low-resource settings are funded primarily by a limited number of large foundations, pharmaceutical firms (“industry”), and national governments. While clinical trial protocols are required to go through reviews in regulatory and ethical domains, outside of industry-funded trials, funders rarely require focused scientific design reviews. There are no documented standards and processes, or even best practices, for funders to perform scientific reviews after the funding commitment. Considering the investment in and standardization of ethical and regulatory reviews, and the prevalence of studies ending without clarity or never finishing, it may be that scientific reviews of trial designs with a focus on informativeness offer the best chance for improved outcomes and return on investments in clinical trials. A maturity model is a helpful tool for knowledge transfer to help grow capabilities in a new area, or for those looking to perform a self-assessment in an existing area. Such a model is offered for scientific design reviews of clinical trial protocols: a valuable and often-neglected governance step for funders or sponsors, among others. This maturity model includes 11 process areas and 5 maturity levels. Each of the 55 process area levels is populated with descriptions on a continuum toward an optimal state to improve trial protocols in the area of risk of failure. This tool allows for prescriptive guidance on next investments to improve attributes of post-funding reviews of trials, with a focus on informativeness.
Le Profil de politique cible (TPoP) est un outil destiné à faciliter le dialogue sur les preuves nécessaires pour effectuer un changement de politique. Il vise à articuler clairement le changement de politique proposé, les preuves existantes pour soutenir le changement, les lacunes dans les preuves et la nature des preuves nécessaires pour combler ces lacunes. Il s'agit d'un outil permettant de décider de commander des recherches et d'examiner les études nouvellement proposées dans le contexte des objectifs généraux du programme. Le TPoP sera également utilisé pour décrire le processus et le calendrier d'engagement politique tout au long du cycle de développement du changement de politique proposé. En conséquence, le TPoP servira de point focal pour le dialogue et l'alignement entre les principales parties prenantes dans le processus de génération de politiques, facilitant ainsi un dialogue précoce et substantiel.
يعتبر مخطط السياسة المستهدفة أداة تسهل الحوار حول الأدلة الضرورية لإحداث تغيير في سياسة معينة كما يهدف إلى وضع صياغة واضحة لهذا التغيير المقترح وللأدلة القائمة لدعمه وللثغرات التي تتخللها وطبيعة الأدلة المطلوبة لسد هذه الثغرات. إنها أداة تساعد على اتخاذ القرار بشأن إجراء البحوث وعلى مراجعة الدراسات المقترحة حديثًا في سياق أهداف البرنامج الشاملة. يتم أيضًا استخدام مخطط السياسة المستهدفة في تحديدعملية المشاركة السياسية والجدول الزمني طوال دورة حياة تطور التغيير المقترح في السياسة. ونتيجة لذلك،يعمل المخطط كنقطة محورية للحوار والمواءمة بين الأطراف المتداخلة في عملية وضع السياسات، مما يسهل الحوار المبكر والموضوعي.
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