{"id":12208,"date":"2021-12-23T22:30:34","date_gmt":"2021-12-24T06:30:34","guid":{"rendered":"https:\/\/www.cloudbyz.com\/blog\/?p=12208"},"modified":"2024-05-28T00:47:08","modified_gmt":"2024-05-28T07:47:08","slug":"machine-learning-in-pharmacovigilance-overview-of-current-and-potential-ai-uses","status":"publish","type":"post","link":"https:\/\/www.cloudbyz.com\/resources\/pharmacovigilance\/machine-learning-in-pharmacovigilance-overview-of-current-and-potential-ai-uses\/","title":{"rendered":"Machine Learning in Pharmacovigilance: Overview of Current and Potential AI Uses"},"content":{"rendered":"<p style=\"text-align: center;\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-12213 size-full alignnone\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/robot-hands-type-AI.jpg\" alt=\"\" width=\"1280\" height=\"747\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/robot-hands-type-AI.jpg 1280w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/robot-hands-type-AI-300x175.jpg 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/robot-hands-type-AI-1024x598.jpg 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/robot-hands-type-AI-768x448.jpg 768w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">Here\u2019s a clich\u00e9: The future is here. Particularly for pharmacovigilance (PV) solution users. Anybody working with PV software solutions in the next few years is going to experience a major change; working with PV solutions driven by machine learning (ML) algorithms. Whether you\u2019re a veteran of the life sciences or you\u2019re just starting your career in the field, machine learning will likely be part of the PV solution your organization uses very soon, so you will be experiencing this change unless you change your career.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But what does that mean exactly? If you\u2019re not an enthusiast of fields like computer science or robotics, you might not have had occasion to look too deeply into machine learning. Sure, you\u2019ve heard the word tossed around, along with the words \u201cArtificial Intelligence\u201d (AI). And everyone likely has some vague idea informed by common references as to what Artificial Intelligence is. But a lot of stakeholders in clinical research and post-marketing surveillance of drugs never had occasion to examine these concepts very closely. You generally hear that some of the solutions you use at work are powered by AI to some degree and that it\u2019s supposed to improve the execution of certain functions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">At a similar depth, you heard the words \u201cmachine learning\u201d being discussed. Those of you who follow discussions for years ahead might have even learned a little more about how ML can assist with pharmacovigilance functions when it\u2019s finally implemented. <\/span><a href=\"https:\/\/globalforum.diaglobal.org\/issue\/april-2018\/machine-learning-in-pharmacovigilance\/\"><span style=\"font-weight: 400;\">Because during 2018, ML in PV was not in the implementation phase<\/span><\/a><span style=\"font-weight: 400;\">. Nor was machine learning <\/span><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/30876845\/\"><span style=\"font-weight: 400;\">implemented in 2019<\/span><\/a><span style=\"font-weight: 400;\">. By implementation, we\u2019re talking about PV software solutions in active, widespread, clinical use which actually involve ML.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Up until 2020, the dialogue about machine learning in pharmacovigilance was dominated by theoretical analysis of the possible benefits, interspersed with occasional experimentation. But now, starting from 2021, we are witnessing the first implementation of ML in PV. The United States\u2019 Food and Drug Administration (FDA) launched the FDA Adverse Event Reporting System II (FAERS II), which features ML-driven end-to-end automation of adverse event report processing. So, it might be a clich\u00e9, but it\u2019s a clich\u00e9 because it\u2019s true. The future is here.<\/span><\/p>\n<p><b>Machine Learning &amp; Artificial Intelligence<\/b><\/p>\n<p><img decoding=\"async\" class=\"alignnone wp-image-12214 size-full\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/machine-learning-2021-08-31-09-14-43-utc.jpg\" alt=\"\" width=\"1280\" height=\"768\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/machine-learning-2021-08-31-09-14-43-utc.jpg 1280w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/machine-learning-2021-08-31-09-14-43-utc-300x180.jpg 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/machine-learning-2021-08-31-09-14-43-utc-1024x614.jpg 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/machine-learning-2021-08-31-09-14-43-utc-768x461.jpg 768w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">But what does machine learning mean exactly? Now that it\u2019s going to affect pharmacovigilance more closely, let\u2019s do that quick overview of ML. You know. That overview you\u2019ve been avoiding. You\u2019ll often hear people saying things like \u201cAI <\/span><b><i>and<\/i><\/b><span style=\"font-weight: 400;\"> Machine Learning\u201d. <\/span><a href=\"https:\/\/www.rtinsights.com\/how-ai-and-machine-learning-can-revolutionize-drug-safety-monitoring\/\"><span style=\"font-weight: 400;\">Even highly specialized industry commentators<\/span><\/a><span style=\"font-weight: 400;\">. And truthfully, they\u2019re not necessarily wrong. Amongst certain computer science enthusiasts, saying \u201cAI &amp; ML\u201d is understood to mean \u201cAI in general &amp; ML in particular\u201d. Saying \u201cML &amp; AI\u201d can mean \u201cML and other AI applications\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But the truth is, for life sciences\u2019 veterans with no professional affiliation to, or deep personal interest in computer science, reading phrases like that can be highly misleading. It suggests that ML and AI are two separate aspects of computer science. They\u2019re not. Machine learning is, in fact, a part of artificial intelligence. Machine learning grew out of artificial intelligence, and although many would argue it\u2019s grown into a separate field altogether, the predominant arguments are that ML remains a part of AI. Even those who disagree will concede that machine learning came from the artificial intelligence field.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AI as a field is generally concerned with studying \u201cintelligent agents\u201d, which includes any system that can identify enough of its environment to initiate actions that increase the system\u2019s chance of attaining successful results. This means that designing AI technology is the effort to build such intelligent agents. There are multiple approaches to building such intelligent agents. For example, systems can be designed to apply logical steps based on probability, for tasks that require fairly linear reasoning or problem-solving skills.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Machine learning, however, is an advanced approach within artificial intelligence. Machine learning involves the designing of computer algorithms that automatically refine and improve their own parameters by experiencing results in the form of data. The algorithms are primarily designed to build models extracted from sample data, which machine learning pioneers call training data. These models help the algorithms make predictions and decisions they weren\u2019t specifically programmed to make, and as the data collected from the results grows, the models\u2019 parameters are changed and refined.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this way, the algorithm supposedly \u201clearns\u201d from the data. Machine learning has been applied to a wide variety of industries, having been used to filter emails, recognize speech, and assist with healthcare (although its use in PV is new). The role of machine learning algorithms is to provide the flexibility required to achieve desired results in highly data-variable environments, whenever the conventional algorithms used to accomplish tasks in more data-stable environments cannot be utilized.<\/span><\/p>\n<p><b>Machine Learning Benefits in Pharmacovigilance<\/b><\/p>\n<p><img decoding=\"async\" class=\"alignnone wp-image-12219 size-full\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/labcoat-servers.jpg\" alt=\"\" width=\"1280\" height=\"768\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/labcoat-servers.jpg 1280w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/labcoat-servers-300x180.jpg 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/labcoat-servers-1024x614.jpg 1024w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2021\/12\/labcoat-servers-768x461.jpg 768w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<p><span style=\"font-weight: 400;\">So how does machine learning improve upon the predominant approaches to pharmacovigilance before ML was applied? We can look at this from the perspective of the present combined with the immediate future, versus the perspective of the near-but-not-immediate future. In the near-but-not-immediate future, there are any number of new benefits machine learning can bring to pharmacovigilance. For example, there was an experiment published last July, <\/span><a href=\"https:\/\/academic.oup.com\/jamia\/article\/28\/10\/2184\/6322900\"><span style=\"font-weight: 400;\">which attempted to mine adverse drug events (ADEs) from social media<\/span><\/a><span style=\"font-weight: 400;\">. This experiment utilized \u201cDeep Learning\u201d. A form of machine learning. And while the results were rather imperfect, they were manageable.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Of course, challenges that can be managed with a little more effort defy the point of technological application, so don\u2019t expect to see all pharmacovigilance professionals eagerly looking through or referencing datasets from Twitter and Facebook in the next few months. But the manageable results of today are the automated and fine-tuned algorithms of tomorrow. In a year or two, who can say? More immediately however, machine learning can already advance pharmacovigilance norms in numerous ways.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">One of those ways relates to data aggregation. Machine learning has proven to be particularly valuable in scanning for precise types of information from vast and unstructured data sets and extracting parameter-improving conditions as a consequence, with an end result towards automating Adverse Event Report aggregation more efficiently. Unstructured data can be found in various ways, gathered from emails, physical documents, and incidental mentions in other sources. This grants PV teams greater bandwidth and frees up highly-trained professionals from addressing largely repetitive tasks. This is particularly important for teams struggling with smaller numbers due to a shortage of talent in the regional workforce.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Another way in which ML can advance pharmacovigilance in the immediate future is by analyzing vast data sets relating to confirmed adverse reactions and identifying patterns indicative of new patient safety concerns which have hitherto gone unnoticed. Outside of confirmed adverse reactions, machine learning is also currently capable of automating the follow-ups for unconfirmed adverse reaction cases in order to fill in the gaps for datasets that are not optimized for analysis.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Machine learning has not peaked in advancement yet. Its application is imperfect. Its potential for benefiting pharmacovigilance is enormous, but anybody expecting a radical improvement in pharmacovigilance within the space of a short few months should probably stop and take stock of the bigger picture a little bit. Let\u2019s not forget that machine learning is what some streaming services use to predict the kind of shows you might enjoy, based on previous shows that you\u2019d watched. I don\u2019t know about you, but in my experience, they make some wildly inaccurate predictions sometimes. Machine learning is also used by search engines to predict your entries and by giant online stores to predict the kind of purchases you might want to make.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The main thing to do now is to get ready for the role of machine learning in your PV solutions in the upcoming years, as opposed to the upcoming months. As for improvements in the field, predict them confidently, but be a little cautious in your timeline expectations. Because while we can reasonably hope that the machine learning algorithms for processing advert event reports will follow stricter data parameters than the algorithms designed towards expanding sales or streaming viewership, let\u2019s not forget that the root of the technology being used is the same. With the arrival of machine learning in the widespread use of pharmacovigilance, you can expect almost instant <\/span><i><span style=\"font-weight: 400;\">gradual<\/span><\/i><span style=\"font-weight: 400;\"> improvements right now, and <\/span><i><span style=\"font-weight: 400;\">radical<\/span><\/i><span style=\"font-weight: 400;\"> improvements in the general vicinity of \u201ctomorrow\u201d. Just not the immediate tomorrow.<\/span><\/p>\n<p><a href=\"https:\/\/www.cloudbyz.com\/products\/safety_&amp;_pharmacovigilance\"><span style=\"font-weight: 400;\">Cloudbyz Safety and Pharmacovigilance (PV) software<\/span><\/a><span style=\"font-weight: 400;\"> is a cloud-based solution built natively on the Salesforce platform. It offers 360 degree view across R&amp;D and commercial. It also enables pharma, bio-tech and medical devices companies to make faster and better safety decisions. It helps to optimize global pharmacovigilance compliance along with easy to integrate risk management features. Cloudbyz pharmacovigilance software solution easily integrates the required data over a centralized cloud-based platform for advanced analytics set-up along with data integrity. It empowers the end-user with proactive pharmacovigilance, smart features with data-backed predictability, scalability and cost-effective support.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To know more about <\/span><a href=\"http:\/\/cloudbyz.com\"><span style=\"font-weight: 400;\">Cloudbyz<\/span> <\/a><span style=\"font-weight: 400;\">safety &amp; pharmacovigilance contact <\/span><a href=\"mailto:info@cloudbyz.com\"><span style=\"font-weight: 400;\">info@cloudbyz.com<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Here\u2019s a clich\u00e9: The future is here. Particularly for pharmacovigilance (PV) solution users. Anybody working with PV software solutions in the next few years is going to experience a major change; working with PV solutions driven by machine learning (ML) algorithms. Whether you\u2019re a veteran of the life sciences or you\u2019re just starting your career [&hellip;]<\/p>\n","protected":false},"author":30,"featured_media":12213,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":"","spc_primary_category":0},"categories":[267,262,174],"tags":[],"acf":[],"aioseo_notices":[],"secondary_thumbnail":null,"_links":{"self":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/12208"}],"collection":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/comments?post=12208"}],"version-history":[{"count":2,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/12208\/revisions"}],"predecessor-version":[{"id":16730,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/12208\/revisions\/16730"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media\/12213"}],"wp:attachment":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media?parent=12208"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/categories?post=12208"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/tags?post=12208"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}