Morgan is enrolling in a clinical trial for a rare neuromuscular disease. They learn that they will participate in a series of on-site clinic visits for labs and imaging, and they will be supplied with a comfortable wrist-worn technology that will monitor their gait throughout the day. Every week, Morgan will also be asked to record how they are feeling via an electronic survey.
Altogether, these multiple modalities and measurement types will help researchers more comprehensively understand whether a new drug in development will maintain a high quality of life for patients while slowing down disease progression.
The scenario above illustrates several of the major strategy shifts we’ve seen in the pharmaceutical industry in 2023. Trials today embrace multiple data capture methods while maintaining a focus on the patient voice and vetted technologies to make trials more inclusive, more efficient, and more accurate.
ICON has been speaking, collaborating, and building with top pharma throughout the year to help them develop better drugs, faster, for patients. Here are a few observations from this year.
AI transformed the tech world in 2023, but that doesn’t mean it’s new to the scene
The promise of AI is enormous: new insights into molecules and drug targets, advances in cohort selection and screening, operational efficiencies, and more. For patients, AI could mean high quality treatments that address the most meaningful health outcomes get to the market quicker.
Pharma companies are going “all in” on AI to accelerate drug development. The good news: AI has been around for a while, and pharma doesn’t have to take big risks on hypergrowth companies to reap the benefits of artificial intelligence and machine learning. Digital biomarkers have been leveraging AI and ML to train their systems for years, and they represent a tried and true pathway to investing in, and seeing value from, AI.
The world of precision just got a whole lot broader, and it all starts with the measures that matter
Precision medicine has often been a term associated with cancer research. Scientists have leveraged advances in genetic testing to identify treatments for cancer patients on an individual level. Now, we’re starting to see an exciting trend towards precision health — the idea that all patients can benefit from technology innovations to prevent illness, treat disease, and even foster wellness, unique to their needs.
One way to bring the promise of precision health to all humans is through precision measurement. Effective trials start with the right measures — those that matter the most to the patient’s quality of life. We have been building a robust data map of 18,000+ measures to allow researchers to more effectively include the patient voice in their trials and find both the right measure and the right technology for patient-centric, efficient protocol designs.
New frameworks allow for a measures-first, technology-second approach to study design, ensuring researchers are measuring what matters most to patients. (Figure 1 source: An Aligned Framework of Actively-collected and Passively-monitored Clinical Outcome Assessments (COAs) for Measure Selection.)
Streamlining workflows means teams have the right resources at the right time
We’ve heard time and again that pharma companies must be more operationally efficient to keep costs down and speed up drug development. Departments need to share information, collaborate on workflows, and leverage the same insights to move quickly and effectively while priorities shift and costs are cut. The Atlas Platform’s configurability and security allow pharma partners to leverage precision health insights wherever they need it in their workstreams while maintaining rigorous audit and data governance standards. Cutting down on time spent conducting redundant tasks and reviews can have a real impact on the time it takes for drugs to be developed and treatments to become available.
Contact us to learn more.
Blog authored by Matthew Ryan. Originally written for HumanFirst, a company acquired by Icon in january 2024.
In this section
-
Digital Disruption
- 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
-
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