Dataset Information

Artificial intelligence and machine learning in clinical development: a translational perspective.

ABSTRACT: Future of clinical development is on the verge of a major transformation due to convergence of large new digital data sources, computing power to identify clinically meaningful patterns in the data using efficient artificial intelligence and machine-learning algorithms, and regulators embracing this change through new collaborations. This perspective summarizes insights, recent developments, and recommendations for infusing actionable computational evidence into clinical development and health care from academy, biotechnology industry, nonprofit foundations, regulators, and technology corporations. Analysis and learning from publically available biomedical and clinical trial data sets, real-world evidence from sensors, and health records by machine-learning architectures are discussed. Strategies for modernizing the clinical development process by integration of AI- and ML-based digital methods and secure computing technologies through recently announced regulatory pathways at the United States Food and Drug Administration are outlined. We conclude by discussing applications and impact of digital algorithmic evidence to improve medical care for patients.

SUBMITTER: Shah P

PROVIDER: S-EPMC6659652 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Artificial intelligence and machine learning in clinical development: a translational perspective.

Shah Pratik P Kendall Francis F Khozin Sean S Goosen Ryan R Hu Jianying J Laramie Jason J Ringel Michael M Schork Nicholas N

NPJ digital medicine 20190726

Future of clinical development is on the verge of a major transformation due to convergence of large new digital data sources, computing power to identify clinically meaningful patterns in the data using efficient artificial intelligence and machine-learning algorithms, and regulators embracing this change through new collaborations. This perspective summarizes insights, recent developments, and recommendations for infusing actionable computational evidence into clinical development and health c ...[more]

PMID: 31372505

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Project description:Precision medicine is one of the recent and powerful developments in medical care, which has the potential to improve the traditional symptom-driven practice of medicine, allowing earlier interventions using advanced diagnostics and tailoring better and economically personalized treatments. Identifying the best pathway to personalized and population medicine involves the ability to analyze comprehensive patient information together with broader aspects to monitor and distinguish between sick and relatively healthy people, which will lead to a better understanding of biological indicators that can signal shifts in health. While the complexities of disease at the individual level have made it difficult to utilize healthcare information in clinical decision-making, some of the existing constraints have been greatly minimized by technological advancements. To implement effective precision medicine with enhanced ability to positively impact patient outcomes and provide real-time decision support, it is important to harness the power of electronic health records by integrating disparate data sources and discovering patient-specific patterns of disease progression. Useful analytic tools, technologies, databases, and approaches are required to augment networking and interoperability of clinical, laboratory and public health systems, as well as addressing ethical and social issues related to the privacy and protection of healthcare data with effective balance. Developing multifunctional machine learning platforms for clinical data extraction, aggregation, management and analysis can support clinicians by efficiently stratifying subjects to understand specific scenarios and optimize decision-making. Implementation of artificial intelligence in healthcare is a compelling vision that has the potential in leading to the significant improvements for achieving the goals of providing real-time, better personalized and population medicine at lower costs. In this study, we focused on analyzing and discussing various published artificial intelligence and machine learning solutions, approaches and perspectives, aiming to advance academic solutions in paving the way for a new data-centric era of discovery in healthcare.

Project description:IntroductionThe increasing availability of healthcare data and rapid development of big data analytic methods has opened new avenues for use of Artificial Intelligence (AI)- and Machine Learning (ML)-based technology in medical practice. However, applications at the point of care are still scarce.ObjectiveReview and discuss case studies to understand current capabilities for applying AI/ML in the healthcare setting, and regulatory requirements in the US, Europe and China.MethodsA targeted narrative literature review of AI/ML based digital tools was performed. Scientific publications (identified in PubMed) and grey literature (identified on the websites of regulatory agencies) were reviewed and analyzed.ResultsFrom the regulatory perspective, AI/ML-based solutions can be considered medical devices (i.e., Software as Medical Device, SaMD). A case series of SaMD is presented. First, tools for monitoring and remote management of chronic diseases are presented. Second, imaging applications for diagnostic support are discussed. Finally, clinical decision support tools to facilitate the choice of treatment and precision dosing are reviewed. While tested and validated algorithms for precision dosing exist, their implementation at the point of care is limited, and their regulatory and commercialization pathway is not clear. Regulatory requirements depend on the level of risk associated with the use of the device in medical practice, and can be classified into administrative (manufacturing and quality control), software-related (design, specification, hazard analysis, architecture, traceability, software risk analysis, cybersecurity, etc.), clinical evidence (including patient perspectives in some cases), non-clinical evidence (dosing validation and biocompatibility/toxicology) and other, such as e.g. benefit-to-risk determination, risk assessment and mitigation. There generally is an alignment between the US and Europe. China additionally requires that the clinical evidence is applicable to the Chinese population and recommends that a third-party central laboratory evaluates the clinical trial results.ConclusionsThe number of promising AI/ML-based technologies is increasing, but few have been implemented widely at the point of care. The need for external validation, implementation logistics, and data exchange and privacy remain the main obstacles.

Dataset Information

Artificial intelligence and machine learning in clinical development: a translational perspective.

Publications

Artificial intelligence and machine learning in clinical development: a translational perspective.

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