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.

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.

EMR-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. From partnerships with IBM Watson, EHR4CR, and TriNetX, ICON is leveraging millions of de-identified patient records from integrated research networks to instantly locate suitable participants, identify optimal study sites, and iteratively refine trial protocols in real-time.

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 Success with 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 — from dose-finding challenges to inadequate sample sizes. Applied across an entire portfolio, adaptive design strategies transform success rates and ensure that limited capital is focused on the fast development of productive assets.

Scientist with test tubes

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.

Elevate Site Centricity

Late-phase studies use more sites than in the past – often hundreds around the world. As many sites have little research experience, how can one ensure that conducting a study is a positive, motivating experience? 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

From objective measurements of real-world activity to site-less studies, mobile technologies enable clinical trials to seamlessly extend beyond the confines of the hospital. 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.

From collecting richer data and reducing site visits to beyond-the-pill strategies that support product launch and marketing, mobile devices represent the future state of development strategy.

Risk Based Monitoring

What if monitors could proactively remove risks, rather than reactively triage them? ICON’s methodology, Patient Centric Monitoring, empowers the early detection and mitigation of errors that can be difficult to otherwise detect. With this adaptive approach, monitors are now able to reveal underlying causes of common issues that jeopardise trial integrity and target areas which have the greatest potential to improve patient safety.

Rethink Strategic Partnerships

Is your clinical partnership evolving to ensure sustained growth? ICON has sponsored research, is embedding practices and innovations that will enable partnerships to move beyond incremental R&D efficiencies and establish truly transformative collaborations in clinical development.

Precision Trials

We are in a new era of opportunity for genomic, proteomic, metabolomic data to advance precision medicines. By supporting data management for the 100,000 Genomes Project and groundbreaking biomarker research, ICON is accelerating the development of truly targeted diagnostic tests and targeted therapies. Using results from these initiatives, sponsors can improve the standard of care through individualised, evidence-based treatments that pave the path to more positive patient outcomes.

Your Transformation Agenda

ICON experts, joined by co-authors at AstraZeneca, Bayer, Boehringer Ingelheim, IBM, McGill University, the Tufts Center for the Study of Drug Design, and 22 other institutes and companies, set forth a comprehensive collection of reforms for a progressive model of drug development. They answer tough questions, such as what causes good drugs to fail? Why do so many expenditures in clinical trials not benefit patients? The answers can spur reforms of fundamental processes that, when implemented together, represent a new business model for drug development.