The traditional clinical development model needs to change.
The cost pressures on drug development are driving the search for savings. Download our in-depth white paper based on an industry survey of pharma executives.
Regulatory agencies are encouraging the use of adaptive design as it can reduce time-to-market and cut development costs
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.
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. Discover more.
Much of the foundational innovation needed to transform clinical development enterprise exists today, and enjoys explicit regulatory support.
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.
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.
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.
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.
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Vast amounts of data from electronic medical records (EMRs), combined with novel analytics technologies, have the potential to revolutionise clinical trial recruitment and feasibility.
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.
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.