Transforming Trials

The traditional clinical development model needs to change.

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.

Ensuring the validity of clinical outcomes assessment data: The value of rater training

The necessity of appropriately training raters for reducing variability in measurements, rater interpretation, and bias and scale administration errors in COA implementation are outlined in this whitepaper.

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Optimising biotech funding whitepaper series

In this two-part whitepaper series on biotech funding, we firstly share insights on how biotechs can secure funding in a highly competitive market, and then shed light on the opportunities available to utilise these funds more effectively and efficiently.

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Using innovative tools and lean writing processes to accelerate regulatory document writing

In this whitepaper, we explore how these valuable tools, including software, templates and collaborative work processes, can provide practical solutions to common challenges medical writers face.

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2023 biotech sector survey

Navigating biotech's challenges and embracing a promising tomorrow

Using exclusive data from ICON’s 2023 survey with Citeline, this report presents valuable insights from 133 influential decision-makers within biotech and venture capital organisations from across North America, Europe, and Asia Pacific.

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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. 

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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.

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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.


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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.

Related article on eCOA.

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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.

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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.

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Agile 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
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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
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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.

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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.

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 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.

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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.

Design for the patient experience

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

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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.

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