Transforming Trials
The traditional clinical development model needs to change.
Decentralised & hybrid clinical trial solutions
With the rising cost and time to bring new drugs to market, the demand for decentralised and hybrid trials has steadily risen.
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands.
These include managing product pipelines targeting smaller and more heterogeneous indications, meeting rising standards of evidence from payers that are moving towards value-based reimbursement models, and addressing the patient’s rising role in care decisions.
Our industry must adopt an entirely new framework for development infrastructure and processes. Focus must go beyond cost containment alone, and instead unlock value through fundamental reforms that allow sponsors to move more treatments to market faster.
Risk Based Quality Management
Our risk based, patient focused methodology for the design and execution of an adaptive monitoring strategy already has a quality management system, risk management system and innovative proprietary technology to support implementation of new ICH GCP guidelines.
Read the whitepaperLeveraging historical data for use in rare disease trials
Small patient populations, pediatric populations and the desire by patients to receive active therapy while on a clinical trial make rare disease trials more challenging, and more suitable for incorporating historical data into the design. Read our whitepaper for insights on this approach.
Read the whitepaperAgile clinical monitoring
Our whitepaper examines how agile clinical monitoring provides the flexibility to keep your trials on track.
Topics include:
- The changing dynamic of clinical monitoring
- Assessing models for quality and flexibility
- Considerations in Remote monitoring
- Integrated technology strategy
- Hybrid monitoring model – the model for the future
Bringing clarity and focus to the research question: the role of estimands
The International Council for Harmonisation (ICH) guideline E9 Statistical Principles for Clinical Trials was issued in 1998 and in November 2019 an addendum to ICH E9 (R1) was issued relating to estimands and sensitivity analyses. This Whitepaper outlines the basics of estimands, and discusses their proposed deployment for improving the quality of clinical research.
Read moreIncreasing complexity and declining ROI in drug development
Find out more about how other organisations such as TEVA and UCB Biosciences are managing the evolving challenges of drug development and read the insights of an eminent doctor who has a unique perspective due to his varying roles in the industry.
Topics covered in the report:
- Is increasing complexity, reality or myth?
- Complexity: a necessary evil or is there a better way?
- Drug development with fresh eyes and new perspectives
- Patient power and dynamics
- Engaging the investigator for better outcomes
- Virtual trials – extending the reach of clinical trials Areas of focus to decrease the cost of R&D
Digital disruption in pharma and the need to transform clinical trials
Watch ICON’s CIO, Tom O’Leary in conversation with Hannah Kuchler, US Pharma and Biotech Correspondent discuss digital disruption in pharma and the need to transform clinical trials. Recorded late November 2019 at the Financial Times Global Pharmaceutical and Biotechnology conference in London.
Utilising emerging technologies
Chen Admati (Intel) and Marie McCarthy (ICON) talk about utilising emerging technologies to improve the efficiency of research and development in the pharmaceutical industry in this PharmaVOICE podcast. Listen now.
ICON’s Transforming Trials initiative is a continuous quality improvement process that
- Confronts fundamental risks that cause high failure rates
- Disrupts inefficient processes with EHR-driven analytics
- Integrates payer, provider, and patient priorities at early decision-points
- Accelerates precision medicine and development for rare and orphan indications
- Leverages mobile technologies both to enhance trials and support a product ecosystem
- Facilitates a continuously learning clinical ecosystem
Much of the foundational innovation needed to transform clinical development enterprise exists today, and enjoys explicit regulatory support.
Improving Pharma R&D efficiency
The cost pressures on drug development are driving the search for savings. Whilst large-scale operational efficiencies are being instituted in many pharmaceutical organisations, efforts need to be integrated if they are to be effective.
- Article: How digital is reversing fortunes in R&D
- Improving Pharma R&D efficiency: The case for a holistic approach to transforming clinical trials
- Article: Improving Pharma R&D efficiency - the need to transform clinical trials (PDF)
- Article: Applied Clinical Trials: Improving Pharma R&D
- Webinar: Improving R&D Efficiency - why 62% of companies are planning a holistic approach to transform clinical trials.
Real World Intelligence™
Based on deep insights into emerging evidence needs, ICON experts design real-world data collection strategies that build a compelling clinical and economic case as trials progress rather than after regulatory approval – often saving millions in post-market study costs and payer authorisation delays.
- ICON Real World Data (RWD) Insights
- White Paper: Harnessing technology to maximise RWE value
- ICON and ICHOM unveil the world’s first global patient outcomes benchmarking platform
- White Paper: Meeting evidentiary needs with EHRs
- On formulary fast: accelerating the access and reimbursement process
- Reduce the cost of post-market surveillance with Real-World Data
Adaptive Design
Adaptive designs remove unnecessary risk from trials, both for patients and sponsors. ICON combines powerful statistical methodologies with novel technology suites such as ADDPLAN and FLEXADVANTAGE to design and execute efficient studies that mitigate problems that too often undermine good products.
Design for the patient experience
ICON is empowering patients, encouraging compliance, and easing the burden of participating in trials through its FIRECREST digital platform, backed by extensive research on behavioural decision-making and information technology.
- ICON reveals voice-assistant applications for clinical trials
- Leveraging voice-assistant technology in clinical trials
- How patients and developers benefit in a digital health ecosystem
- Multimedia approach to eConsent instils patient trust in clinical trials
- ICON and Carnegie Mellon University collaborate to evaluate patient-centric informed consent processes
Transforming Trials email updates
If you would like to receive our Transforming Trials email updates, including the latest on accelerating R&D timelines and minimising costs, adaptive design, CRO partnership strategy, risk-based monitoring, as well as reducing site & investigator burden, click here to go to our preference centre.
Receive Transforming Trials email updatesEMR-driven innovation
Vast amounts of data from electronic medical records (EMRs), combined with novel analytics technologies, have the potential to revolutionise clinical trial recruitment and feasibility.
Elevate site centricity
ICON is transforming the daily experiences of site staff through novel technologies that reduce the burden of participation and a novel centralised site management model, delivered through regional hubs fluent in local languages and customs, that provides a single point of contact from start to finish.
Leverage mobile technology
ICON is investing heavily in security and data validation standards for wearable devices and mobile applications, so that sponsors can take advantage of opportunities to augment clinical and economic outcomes measures, and make studies more convenient and accessible for patients around the world.
- White paper: Transforming medical device development with mHealth
- Remote monitoring, wearables and sensors in clinical trials
- Measuring free-living activity in clinical trials
- Bring your own device (BYOD) eCOA – instrument validation methodology
- ICON pilots new app for aging research in connected health study
CRO partnership strategies
CROs can provide a range of expertise to bring know how and solutions to the highly technical challenges of transforming clinical trials. In the 2018 ICON and Informa industry survey 'Improving Pharma R&D Efficiency', executives were asked 'How important will strategic partnerships with CROs be to the success of your clinical trials in the next 5 years?' 83% of respondents stated such relationships would be 'Very Important' or 'Important'. Earlier ICON sponsored research in 2016 on 'Optimising Collaboration Effectiveness in Alliance Partnerships' conducted by Tufts identified four key themes for optimising collaboration effectiveness:
- Evolve the partnership model to 'Design & Execution'
- Develop a joint innovation agenda
- Implement an integrated approach to patient centricity
- Build partnership trust
Transforming medical device development
To sustain rapid revenue growth, medical device manufacturers are increasingly turning to significant corporate cost saving programmes, often requiring across-the-board cuts between 15 and 30%.
Companies are under enormous pressure to introduce products to market faster while also meeting the escalating demands of regulators and payors for post-market research, requiring investment in infrastructure and expertise to maximise reimbursement and keep products on the market.
How can manufacturers effectively reconcile these seemingly contradictory challenges?
White paper: Transforming medical device development: achieving challenging mandates for cost savings and pipeline productivity