scholarly journals Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed

2019 ◽  
Vol 25 (10) ◽  
pp. 1467-1468 ◽  
Author(s):  
2021 ◽  
Vol 116 (1) ◽  
pp. S268-S269
Author(s):  
Erik A. Holzwanger ◽  
Mohammad Bilal ◽  
Jeremy Glissen Brown ◽  
Ishita Barua ◽  
Mandeep S. Sawhney ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hussein Ibrahim ◽  
Xiaoxuan Liu ◽  
Samantha Cruz Rivera ◽  
David Moher ◽  
An-Wen Chan ◽  
...  

Abstract Background The application of artificial intelligence (AI) in healthcare is an area of immense interest. The high profile of ‘AI in health’ means that there are unusually strong drivers to accelerate the introduction and implementation of innovative AI interventions, which may not be supported by the available evidence, and for which the usual systems of appraisal may not yet be sufficient. Main text We are beginning to see the emergence of randomised clinical trials evaluating AI interventions in real-world settings. It is imperative that these studies are conducted and reported to the highest standards to enable effective evaluation because they will potentially be a key part of the evidence that is used when deciding whether an AI intervention is sufficiently safe and effective to be approved and commissioned. Minimum reporting guidelines for clinical trial protocols and reports have been instrumental in improving the quality of clinical trials and promoting completeness and transparency of reporting for the evaluation of new health interventions. The current guidelines—SPIRIT and CONSORT—are suited to traditional health interventions but research has revealed that they do not adequately address potential sources of bias specific to AI systems. Examples of elements that require specific reporting include algorithm version and the procedure for acquiring input data. In response, the SPIRIT-AI and CONSORT-AI guidelines were developed by a multidisciplinary group of international experts using a consensus building methodological process. The extensions include a number of new items that should be reported in addition to the core items. Each item, where possible, was informed by challenges identified in existing studies of AI systems in health settings. Conclusion The SPIRIT-AI and CONSORT-AI guidelines provide the first international standards for clinical trials of AI systems. The guidelines are designed to ensure complete and transparent reporting of clinical trial protocols and reports involving AI interventions and have the potential to improve the quality of these clinical trials through improvements in their design and delivery. Their use will help to efficiently identify the safest and most effective AI interventions and commission them with confidence for the benefit of patients and the public.


Author(s):  
Francesco Piccialli ◽  
Vincenzo Schiano di Cola ◽  
Fabio Giampaolo ◽  
Salvatore Cuomo

AbstractThe first few months of 2020 have profoundly changed the way we live our lives and carry out our daily activities. Although the widespread use of futuristic robotaxis and self-driving commercial vehicles has not yet become a reality, the COVID-19 pandemic has dramatically accelerated the adoption of Artificial Intelligence (AI) in different fields. We have witnessed the equivalent of two years of digital transformation compressed into just a few months. Whether it is in tracing epidemiological peaks or in transacting contactless payments, the impact of these developments has been almost immediate, and a window has opened up on what is to come. Here we analyze and discuss how AI can support us in facing the ongoing pandemic. Despite the numerous and undeniable contributions of AI, clinical trials and human skills are still required. Even if different strategies have been developed in different states worldwide, the fight against the pandemic seems to have found everywhere a valuable ally in AI, a global and open-source tool capable of providing assistance in this health emergency. A careful AI application would enable us to operate within this complex scenario involving healthcare, society and research.


Author(s):  
Riwa Meshaka ◽  
Daniel Pinto Dos Santos ◽  
Owen J. Arthurs ◽  
Neil J. Sebire ◽  
Susan C. Shelmerdine

2021 ◽  
Vol 14 ◽  
pp. 263177452199062
Author(s):  
Benjamin Gutierrez Becker ◽  
Filippo Arcadu ◽  
Andreas Thalhammer ◽  
Citlalli Gamez Serna ◽  
Owen Feehan ◽  
...  

Introduction: The Mayo Clinic Endoscopic Subscore is a commonly used grading system to assess the severity of ulcerative colitis. Correctly grading colonoscopies using the Mayo Clinic Endoscopic Subscore is a challenging task, with suboptimal rates of interrater and intrarater variability observed even among experienced and sufficiently trained experts. In recent years, several machine learning algorithms have been proposed in an effort to improve the standardization and reproducibility of Mayo Clinic Endoscopic Subscore grading. Methods: Here we propose an end-to-end fully automated system based on deep learning to predict a binary version of the Mayo Clinic Endoscopic Subscore directly from raw colonoscopy videos. Differently from previous studies, the proposed method mimics the assessment done in practice by a gastroenterologist, that is, traversing the whole colonoscopy video, identifying visually informative regions and computing an overall Mayo Clinic Endoscopic Subscore. The proposed deep learning–based system has been trained and deployed on raw colonoscopies using Mayo Clinic Endoscopic Subscore ground truth provided only at the colon section level, without manually selecting frames driving the severity scoring of ulcerative colitis. Results and Conclusion: Our evaluation on 1672 endoscopic videos obtained from a multisite data set obtained from the etrolizumab Phase II Eucalyptus and Phase III Hickory and Laurel clinical trials, show that our proposed methodology can grade endoscopic videos with a high degree of accuracy and robustness (Area Under the Receiver Operating Characteristic Curve = 0.84 for Mayo Clinic Endoscopic Subscore ⩾ 1, 0.85 for Mayo Clinic Endoscopic Subscore ⩾ 2 and 0.85 for Mayo Clinic Endoscopic Subscore ⩾ 3) and reduced amounts of manual annotation. Plain language summary Patient, caregiver and provider thoughts on educational materials about prescribing and medication safety Artificial intelligence can be used to automatically assess full endoscopic videos and estimate the severity of ulcerative colitis. In this work, we present an artificial intelligence algorithm for the automatic grading of ulcerative colitis in full endoscopic videos. Our artificial intelligence models were trained and evaluated on a large and diverse set of colonoscopy videos obtained from concluded clinical trials. We demonstrate not only that artificial intelligence is able to accurately grade full endoscopic videos, but also that using diverse data sets obtained from multiple sites is critical to train robust AI models that could potentially be deployed on real-world data.


Author(s):  
Diego Alejandro Dri ◽  
Maurizio Massella ◽  
Donatella Gramaglia ◽  
Carlotta Marianecci ◽  
Sandra Petraglia

: Machine Learning, a fast-growing technology, is an application of Artificial Intelligence that has significantly contributed to drug discovery and clinical development. In the last few years, the number of clinical applications based on Machine Learning has constantly been growing. Moreover, it is now also impacting National Competent Authorities during the assessment of most recently submitted Clinical Trials that are designed, managed, or generating data deriving from the use of Machine Learning or Artificial Intelligence technologies. We review current information available on the regulatory approach to Clinical Trials and Machine Learning. We also provide inputs for further reasoning and potential indications, including six actionable proposals for regulators to proactively drive the upcoming evolution of Clinical Trials within a strong regulatory framework, focusing on patient safety, health protection, and fostering immediate access to effective treatments.


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