Seizing the Opportunity to Leverage AI & ML for Clinical Research – Analytics Insight

Pharmaceutical professionals believe artificial intelligence (AI)will be the most disruptive technology in the industry in 2021. As AI and machine learning (ML) become crucial tools for keeping pace in the industry, clinical development is an area that can substantially benefit, delivering significant time and cost efficiencies while providing better, faster insights to inform decision making. However, for patients, these tools provide improved safety practices that lead to better, safer, drugs. Here is how AI/ML can be used to support pharma companies in delivering safer drugs to market.

Today, AI and ML can be used to support clinical research in numerous ways; including the identification of molecules that hold potential for clinical treatments, finding patient populations that meet specific criteria for inclusion or exclusion, as well as analyzing scans, claims reports, and other healthcare data to identify trends in clinical research and treatments that lead to safer and faster decisions.

However, to take full advantage of the benefits of AI/ML technology, organizations performing clinical trials must first gain access to the tools, expertise, and industry-specific datasets enabling them to build algorithms to fit their specific needs. Healthcare data, unlike purely numerical data pulled from monitoring systems and tools such as IoT or SaaS platforms, is typically unstructured due to the way the data is collected (through doctor visits, and unstructured web sources) and must meet strict security protocols to ensure patient privacy.

To truly leverage AI and ML for clinical research, data must be collected, studied, combined, and protected to make effective healthcare decisions. When clinical researchers collaborate with partners that have both technical and pharmaceutical expertise, they ensure that data is being structured and analyzed in a way that simultaneously reduces risks and improves the quality of clinical research.

When it comes to research study design, site identification and patient recruitment, and clinical monitoring, AI and ML hold great potential to make clinical trials faster, more efficient, and most importantly: safer.

Study design sets the stage for a clinical research initiative. The cost, efficiency, and potential success of clinical trials rest squarely on the shoulders of the studys design and plans. AI and ML tools, along with natural language processing (NLP), can analyze large sets of healthcare data to assess and identify primary and secondary endpoints in clinical research design. This ensures that protocols for regulators, payers, and patients are well defined before clinical trials commence. Defining parameters such as these optimize study design by helping to identify ideal research sites and enrollment models. Ultimately, better study design leads to more predictable results, reduced cycle time for protocol development, and a generally more efficient study.

Identifying trials sites and recruiting patients for clinical research is a tougher task than it seems to be at face value. Clinical researchers must identify the area that will provide enough access to patients who meet inclusion and exclusion criteria. As studies become more focused on rarer conditions or specific populations, recruiting participants for clinical trials becomes more difficult, which increases the cost, timeline, and risk of failure for the clinical study if enough patients cannot be recruited for the research. AI and ML tools can support site identification for clinical research by mapping patient populations and proactively targeting sites with the most potential patients that meet inclusion criteria. This enables fewer research sites to meet recruitment requirements and reduce the overall cost of patient recruitment.

Clinical monitoring is a tedious manual process of analyzing site risks of clinical research and determining specific actions to take towards mitigating those risks. Risks in clinical research include recruitment or performance issues, as well as risks to patient safety. AI and ML automate the assessment of risks in the clinical research environment, and provide suggestions based on predictive analytics to better monitor for and prevent risks. Automating this assessment removes the risk of manual error, and decreases the time spent on analyzing clinical research data.

During clinical trials, theres a limited patient population to pull from, as research subjects must meet pre-set parameters for inclusion in the study. On the other hand, as opposed to post-market research, clinical researchers are blessed with vast amounts of information surrounding their patients including what drugs they are taking, their health history, and their current environment.

In addition, because the clinical researcher is working closely with the patient and is well-educated on the drug or product being researched, the researcher is very familiar with all potential variables involved in the clinical trial. To put it simply, clinical trials have a lot of information to analyze, but few patients with whom to conduct the research. Because of this disproportionate ratio of information over patients, every case in a clinical research setting is extremely important to the future of the drug being researched.

The massive amount of patient and drug information available to clinical researchers necessitates the use of NLP tools to analyze and process documents and patient records.NLP can search documents and records for specific terms, phrases, and words that might indicate a problem or risk in the clinical trial. This eliminates the need for manual analysis of clinical trial data reducing, and in some cases eliminating, the risk of human error while also increasing patient safety. This is especially useful in lengthy clinical trials, for which researchers will need to analyze patient histories and drug results over an extended period of time. Many clinical trials have long document trails and questionnaires that can add up to hundreds of pages of patient data that researchers must analyze.

In a clinical trial, researchers are ultimately trying to determine whether the benefits of a specific treatment outweigh the risks. AI can be especially helpful in clinical trials of high-risk drugs. If a researcher knows that a drug cures or alleviates an illness or condition, but also know that the potential side effects of that drug can have a significant negative impact on the patient, theyll want to know how to determine if a patient is likely to present those negative side effects. NLP can be used to produce word clouds of potential signals of the negative side effects of a drug that patients would experience.

The only way to do this type of analysis manually is to identify those words using human researchers, then analyze the patient reports to find those words, and group those reports into risk profiles. NLP can automate that entire process and provide insights on risk indicators in patients much more efficiently and safely than human researchers ever could.

AI and ML technologies, especially NLP, hold huge promise to support and optimize clinical research. However, that assurance can only be achieved by organizations that have the necessary tools, expertise, and partners to leverage the full benefits of AI and ML. AI and ML solutions support the optimization of clinical research by more efficiently analyzing research data for risks and allowing faster trial planning and research. Those who fail to engage AI and ML for clinical research may find that their competitors are doing so, and as a result, are going to market with new drugs and products faster with higher profits due to decreased research time and safer practices.

Updesh Dosanjh, Practice Leader, Pharmacovigilance Technology Solutions, IQVIA

As Practice Leader for the Technology Solutions business unit of IQVIA, Updesh Dosanjh is responsible for developing the overarching strategy regarding Artificial Intelligence and Machine Learning as it relates to safety and pharmacovigilance. He is focused on the adoption of these innovative technologies and processes that will help optimize pharmacovigilance activities for better, faster results. Dosanjh has over 25 years of knowledge and experience in the management, development, implementation, and operation of processes and systems within the life sciences and other industries. Most recently, Dosanjh was with Foresight and joined IQVIA as a result of an acquisition. Over the course of his career, Dosanjh also worked with WCI, Logistics Consulting Partners, Amersys Systems Limited, and FJ Systems. Dosanjh holds a Bachelors degree in Materials Science from Manchester University and a Masters degree in Advanced Manufacturing Systems and Technology from Liverpool University.

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Seizing the Opportunity to Leverage AI & ML for Clinical Research - Analytics Insight