The traditional clinical development model needs to change.
Decentralised clinical trials
With the rising cost and time to bring new drugs to market, the demand for decentralised and hybrid trials has steadily risen.
Flexible delivery models
Insights on customised FSP models, transformational roadmaps and operational execution to enable the most flexible and efficient operating models for Sponsors.
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.
Linguistic validation of clinical outcomes assessments:
A best-practice approach
In this whitepaper we describe the rigorous, iterative linguistic validation process for COAs that ensures conceptual equivalency and cultural relevance for each required translation.
Digitizing COAs: A streamlined approach to approval
In all aspects of life, paper copies are giving way to electronic versions of documents. Clinical research is no exception as there is an ongoing push to capture trial data electronically to improve both the participant experience and data quality. Download the whitepaper from Mapi Research Trust to discover success factors in converting from paper to digital.
The COA licensing process: How to prepare for success
The prerequisites for controlled use of Clinical Outcome Assessments (COAs) and suggestions for streamlining the licensing process, which can be complex and typically involves multiple parties, are detailed in this whitepaper from Mapi Research Trust.
Keeping eCOA implementation off a trial’s critical path
A best-practice approach
In this whitepaper we describe what is involved in adopting an eCOA solution and share a recommended approach to planning and implementing eCOA that will eliminate surprises and mitigate the risks of delaying the study start up.
Whitepaper: Best practices to increase engagement with medical and scientific poster content
Scientific posters are in need of a design overhaul. Poster sessions are a valuable opportunity to communicate research with a large audience. However, traditional posters rely on an information-dense design and often fail to make a lasting impression.
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.
Case Study: Supporting a top 10 pharma to transition its full study portfolio quickly and efficiently to Veeva Vault platform
Find out how ICON helped a client that was looking to deploy a more effective clinical trial technology platform that would meet its needs across a wide portfolio of studies.
Agile clinical monitoring
Our whitepaper examines how agile clinical monitoring provides the flexibility to keep your trials on track.
- 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
Increasing 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
Innovation in clinical trial methodologies
In a timely new book edited by Dr Peter Schueler, Senior VP Drug Development Services, Neurosciences, at ICON plc, authors explore how, by learning the right lessons, the industry and wider society could be entering a golden age of drug development.
ICON is pleased to offer a code for a 30% discount on individual purchases, and a 50% discount on bulk purchases (more than 10) – simply complete the short form to receive your discount code and link to purchase the book.
Digital disruption in pharma and the need to transform clinical trials
ICON's Dr. Greg Licholai, Chief Medical & Innovation Officer took part in a panel discussion: Dynamic clinical trial models at the 2022 Financial Times US Pharma and Biotech Summit. The panel discussion covered a wide range of topics including how the COVID-19 pandemic accelerated innovation in clinical trials, especially in terms of how to connect with patients and investigators.
The challenges of the pandemic have pushed CROs and sponsors to embrace new ways of conducting clinical trials that offer significant advantages going forward. At the 2021 Financial Times US Pharma and Biotech Summit, ICON CEO Dr. Steve Cutler discussed these developments in a post-pandemic clinical trials landscape and recent developments in the CRO market.
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.
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: R&D outsourcing trends roundtable
- 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.
Adaptive designs remove unnecessary risk from trials, both for patients and sponsors. ICON combines powerful statistical methodologies with novel technology suites such as FLEXADVANTAGE to design and execute efficient studies that mitigate problems that too often undermine good products.
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.
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
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.
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: Wearables and digital endpoint strategy and validation
- White paper: Transforming medical device development with mHealth
- Remote monitoring, wearables and sensors in clinical trials
- Blog: Post pandemic cliicla trial strategies
- Measuring free-living activity in clinical trials
- Bring your own device (BYOD) eCOA – instrument validation methodology
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?