The best approach to maximise RWE technology platform output through the use of advanced computing
Bruce Capobianco
Technology industry buzzwords - AI, ML, NLP, to name a few - have been making their way into the public vernacular more and more in recent years. For the pharma and biotech industries, the applications of these buzzwords are far reaching, particularly when it comes to processing large data sets to generate RWE.
As the availability of big data continues to grow exponentially, it only makes sense that new ways of applying these advanced computing skills to process these data sets would become available as well. But what specifically do they mean, what are their differences, what operational processes do they perform and what are the advantages of implementing these innovative technologies in a centralized and secure RWE technology platform?
Let’s start with high level definitions:
Artificial Intelligence (AI): In its simplest form, AI is the development of computer systems to perform tasks that normally require human intelligence. There are many computing functions today that fall in to the AI bucket.
Machine Learning (ML): A subset of AI that enables computers to discover patterns in large data sets, make predictions and improve these predictions over time with repeated exposure to the data. There are three subcategories of ML:
- Supervised Learning: Can discover patterns when examples of those patterns are provided; usually called upon for predictive analytics
- Unsupervised Learning: Can discover patterns without specific examples; most useful when grouping data
- Reinforcement Learning: Based on trial and error; can learn from failures to understand which process works the best; most useful with robotized functions.
The next evolution of ML, often times referred to as Deep Learning, is advanced computing that most closely resembles the way a human brain would process information. Deep Learning involves learning by example and making informed decisions automatically from what it has learned.
Natural Language Processing (NLP): A component of AI that enables computers to understand and process unstructured text and extract meaning from it. A prime research example of NLP would be mining text-based physician notes for pertinent research study data.
Now that we’ve reviewed these terms, let’s discuss five ways that these innovative technologies can be utilized to improve efficiencies in real world data ingestion, normalization and outcomes research.
- When ingesting massive amounts of secondary data from dissimilar sources, there is a need to link and normalize the data into a common data model to generate meaningful insights. In the past, this normalization could only be done manually, and could take a prohibitive amount of time. Now with NLP and ML, the entire end-to-end process can be automated and insights can be generated in a fraction of the time.
- In patient treatment pathways, ML can be used to analyse and compare treatment effectiveness of a particular drug or therapy and ensure, from a payer’s perspective, the prescribed treatment is meeting value expectations.
- Current processes with uncovering adverse events have been quite laborious, with many hours spent mining through data inputs to track and log actual events. With innovative approaches driven by NLP, these large data sets can now be processed in record time. This approach opens up new social repositories of data for mining.
- In the foreseeable future, physicians will be able to rely on AI to better determine if a patient is at high risk for developing certain diseases. Based on available secondary data sources and learned predictive modelling, a patient’s profile can be aligned with these models to identify markers that would determine risk levels.
- With data being collected into electronic health records (EHRs), we now have better access to RWD and ability to track patient behaviour and treatment adherence. ML can be applied to these data sets and used to predict which patients are more likely to discontinue a drug or therapy for a chronic disease. With this analysis, pharma and biotech companies can then take action to focus on improving patient adherence and in turn, increase revenue.
The technology advancements of AI, ML and NLP, as seen in these examples, offer pharma and biotech companies the power to increase meaningful RWE output, decrease time to insights, and make the most of the vast data sources now available. An RWE technology platform that delivers smart data processing, analysis and outcomes offers an unparalleled opportunity to capitalize on these computing advancements. When used as part of an overall comprehensive RWE strategy, AI, ML, and NLP innovations can enhance drug development, improve patient treatment and access, and drive valuable new business opportunities.
Learn more
To learn more or to discuss your real world data needs, contact our Real World Evidence (RWE) team.
About the Author
Bruce Capobianco has over 25 years’ experience in the architecture, development and implementation of complex big data solutions. He leads a team to develop, enhance, and maintain Real World Evidence (RWE) technology solutions for ICON clients. He has a proven track record of identifying and implementing secure, usable and enduring technologies that augment business processes and optimize productivity. At Syneos he led a global team of architects, developers, PMs and SQA staff in the development of a HIPAA-compliant, trial patient recruitment system, and established and drove disruptive technology trends for competitive advantage.
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption whitepaper
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel