ARTIFICIAL INTELLIGENCE (AI) IN

CLINICAL TRIALS

K. SOMESWARA RAO
M. Pharm, Ph.D.
 Outline
• Definition and Subfields.
• AI in healthcare market size worldwide
from 2021 to 2030.
• Types of Artificial Intelligence.
• AI in Health Care.
• Traditional Drug development process.
• Drawbacks of Traditional Drug
development process.
• Role of artificial intelligence (AI) in
drug discovery.
• Current and Potential Uses of AI/ML in
the Drug Development Process
• Cost Drivers in Clinical Trials.
• Applications of AI from drug discovery
to pharmaceutical product
management.
• Artificial Intelligence in clinical trials
• Application of AI in clinical trials.
• New way to optimize the Clinical trials:
The Smart-trials era.
• Applications of AI-enabled technology
in clinical trials.
• How AI technologies can help deliver
clinical trial enrichment strategies.
• Expected timeline for the adoption of
AI-enhanced digital technologies at
scale.
• Artificial Intelligence (AI) tools used in
drug discovery.
• Overview of cases and mapping to
artificial intelligence framework.
 Artificial Intelligence (AI) Definition

Artificial Intelligence (AI) is a field of computer science that is

associated with the concept of machines “thinking like humans”
to perform tasks such as learning, problem solving, planning,
reasoning, identifying patterns.
(OR)
Artificial Intelligence (AI): A branch of computer science,
statistics, and engineering that uses algorithms or models that
exhibit behaviors such as learning, making decisions, and
making predictions.
Artificial Intelligence (AI) Definition and Subfields
 Artificial Intelligence (AI) Subfields

AI come up following subfields

• Machine Learning (ML).

• Deep Learning (DL).
• Neural Networks
• Natural language processing (NLP), combined with an
effective digital infrastructure.
• Computer Vision
• Cognitive Computing
 Artificial Intelligence (AI) Subfields
Machine Learning (ML): A branch of AI that provides systems with the
ability to develop models through analysis of data without being
explicitly programmed and to improve based on data or experience.

Deep Learning: Deep Learning is an ML technique. It teaches a machine

to process inputs through layers in order to classify, infer and predict the
outcome.

Neural Networks: Neural Networks work on similar principles to Human

Neural cells. They are a series of algorithms that captures the
relationship between various underlying variables and processes the data
as a human brain does.
 Artificial Intelligence (AI) Subfields
Natural Language Processing: NLP is a science of reading, understanding,
and interpreting a language by a machine. Once a machine understands
what the user intends to communicate, it responds accordingly.

Computer Vision: Computer vision algorithms try to understand an

image by breaking down an image and studying different parts of the
object. This helps the machine classify and learn from a set of images, to
make a better output decision based on previous observations.

Cognitive Computing: Cognitive computing algorithms try to mimic a

human brain by analysing text/speech/images/objects in a manner that a
human does and tries to give the desired output.
Artificial Intelligence (AI) Subfields
 Artificial Intelligence (AI) in healthcare market size
worldwide from 2021 to 2030 (in billion U.S. dollars)
Types of Artificial Intelligence
Artificial Intelligence (AI) in Healthcare
2023 Survey Results: What can AI do for patients?
9 Principles to Regulate AI in Healthcare
Traditional Drug Development Process
Drawbacks of Traditional Drug Development
Process
Role of Artificial Intelligence (AI) in Drug Discovery
 Current and Potential uses of AI/ML in the Drug
Development Process

A.Drug Discovery

1. Drug Target Identification, Selection, and Prioritization

2. Compound Screening and Design

B. Nonclinical Research.
 Current and Potential uses of AI/ML in the Drug
Development Process
C. Clinical Research
1. Recruitment
2. Selection and Stratification of Trial Participants
3. Dose/Dosing Regimen Optimization
4. Adherence
5. Retention
6. Site Selection
7. Clinical Trial Data Collection, Management, and Analysis
a. Data Collection
b. Data Management
c. Data Analysis
8. Clinical Endpoint Assessment
Current and Potential Uses of AI/ML in the Drug
Development Process
D. Postmarket Safety Surveillance
1. Case Processing
2. Case Evaluation
3. Case Submission
E. Advanced Pharmaceutical Manufacturing
1. Optimization of Process Design
2. Advanced Process Control
3. Smart Monitoring and Maintenance
4. Trend Monitoring
Cost Drivers in Clinical Trials
Applications of Artificial Intelligence (AI) from Drug
Discovery to Pharmaceutical Product Management
 Artificial Intelligence in Clinical Research
Find and create big data to
analyze:
I.A. that harvest between
several databases and
aggregate data,
Use Ai to extract structural
biological knowledge to power
drug discovery application
Cognitive approach to
discover relationship
Uses AI to: Analyze genomic
data related to cancer and
other diseases, Find
applications for existing
approved drugs or clinically
validated candidates.
Optimize the process:
Uses AI to: create a Chat bot
or machine learning system to
prevent issue on clinical trials,
Optimize oncology drug
development with a
biomarker monitoring
platform and millions of
patient datapoints
Match the right patients to
the right cure
Uses AI to Enroll more
patients in appropriate trials,
or uses AI to Analyze medical
records to find patients for
clinical trials
Simulate clinical trials and
silico
AI in clinical Uses AI to Run experiments in
research a central lab from anywhere in
classification the world, or use ai to
Optimize, reproduce,
automate, and scale
experiment workflows.
Publish data;
Uses AI to Write a draft
scientific manuscript based on
provided data.
Application of Artificial Intelligence (AI) in Clinical
Trials

Improve the research process with more efficiency and

Reduce Costs of a CT efficacy

01 Less time means less money. We could use AI

such as a really quick tool to analyze large
amount of data and simulate trials
02
Using AI we could save time and be more
efficacy/efficiency. Creating a new machine learning
models to anticipate issues and enhance research
programs

Expand our knowledge Faster access to therapy for patients

03 We can use Ai to discover relationship and

reproduce a cognitive process to evaluate new
drugs or use old drugs to a new therapeutic
04 Patience can enjoy o new AI tools to be a part
of the research program and be used in active
way
indications
New way to optimize the Clinical trials: The Smart-trials era
Pharma/biomedical companies don’t
reach the patient Add value
New change in Option D Option A All data is validated and ready
relationship with the to use. And we have a huge
patient. All data amount of data
Threat
responsibilities is tied to
the CRO or the provider

Differentiation and big Cost optimizer

data Option E Option B We have less monitoring
From the previous model visits and
we could collect tons of
data. We need automatic
system to analyze
Opportunity
Personalize the therapy
Option F Option C
Real time Using AI we could collect
All the data can be and process data,
collected in real time, but underline only the data
we need a right that interesting us
environment
Applications of Artificial Intelligence (AI) -enabled Technology in
Clinical Trials
How Artificial Intelligence (AI) Technologies Can Help Deliver
Clinical Trial Enrichment Strategies

electronic health records (EHRs)

Expected Timeline for the Adoption of Artificial Intelligence
(AI) -Enhanced Digital Technologies at Scale
 Artificial Intelligence (AI) Tools used in Drug
Discovery
TOOLS DETAILS
Multilayer Perceptron (MLP) model that uses a python-
DeepChem based AI system to find a suitable candidate in drug
discovery
Software that predicts the toxicity of total of 12 000
DeepTox
drugs
DeepNeuralNetQ Python-based system driven by computational tools that
SAR aid detection of the molecular activity of compounds
A molecular generation tool that helps to create
ORGANIC
molecules with desired properties
Uses neural networks (NNs) to predict binding affinity
PotentialNet
of ligands
 Artificial Intelligence (AI) Tools used in Drug
Discovery
TOOLS DETAILS
ML technique to predict molecules that might
Hit Dexter
respond to biochemical assays
A scoring function for rescoring drug–ligand binding
DeltaVina
affinity
Neural graph
Helps to predict properties of novel molecules
fingerprint
AlphaFold Predicts 3D structures of proteins
Helps to report procedure for chemical synthesis in
Chemputer
standardized format
 Overview of Cases and Mapping to AI Framework

AI, artificial intelligence; EHR, electronic healthcare record; GO2PLS, group sparse orthogonal partial least
squares; HCM, hypertrophic cardiomyopathy; PH, pulmonary hypertension; PPG, photoplethysmography.
THANK
YOU