The traditional clinical development model needs to change.
With the rising cost and time to bring new drugs to market, the demand for decentralised and hybrid trials has steadily risen.
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.
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 whitepaper
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 whitepaper
Our whitepaper examines how agile clinical monitoring provides the flexibility to keep your trials on track.
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 more
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:
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.
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.
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.
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:
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?