Obesity
Interdisciplinary expertise in obesity research
As obesity rates continue to rise, many in the healthcare community are turning to medical interventions to counter obesity and its effects. But, obesity’s role as a chronic condition and a risk factor for many diseases poses challenges for clinical development. ICON has the experience and expertise to help sponsors overcome the challenges associated with obesity research and clinical trials.
Cross-disciplinary therapeutic area expertise
ICON’s approach to obesity research draws on therapeutic expertise from the many interrelated conditions linked to obesity. We bring together experts across a broad range of therapeutic areas, device development, innovation technology, translational, regulatory, and real world evidence, for a comprehensive approach to asset development. ICON has deep expertise in:
Integrated approach to obesity studies
There is growing interest in the simultaneous development of assets with significant public health impact across multiple related indications. ICON is exploring potential advantages to innovative uses of master protocols, which are constructed to test multiple hypotheses with an overarching set of procedures intended to improve efficiency.
ICON offers the most comprehensive suite of integrated clinical development services for obesity trials in the industry. We’ve designed flexible and fully customisable solutions to help our customers achieve their goals across a seamless delivery model spanning their product’s entire lifecycle. From small early phase trials to larger pivotal or long-term outcomes trials, we work your way to deliver better outcomes.
Our full range of clinical development services across all phases of drug and device development provide a comprehensive solution for obesity trials.
- Strategic planning Global, robust integrated asset development consulting, covering all phases of drug development enabling more cost-effective and timely product and drug development programmes
- Clinical study design and execution A flexible approach to improve cycle times, constrain costs, and reduce risks through clinical trial planning, management, execution and analysis
- Central lab services A full range of central laboratory services that are dedicated exclusively to clinical development
- Imaging and endpoint adjudication services Integrated solutions based on the science of imaging biomarkers
- Regulatory and QA support Strategic consulting and operational support in a complex environment
- Commercialisation and outcomes Integrated solutions to accelerate market access and drive product adoption
- Strategic resourcing Customised FSP models to drive operational efficiencies and accelerate clinical development
Strategic planning
Global, robust integrated asset development consulting, covering all phases of drug development enabling more cost-effective and timely product and drug development programmes
Clinical study design and execution
A flexible approach to improve cycle times, constrain costs, and reduce risks through clinical trial planning, management, execution and analysis
Central lab services
A full range of central laboratory services that are dedicated exclusively to clinical development
Imaging and endpoint adjudication services
Integrated solutions based on the science of imaging biomarkers
Regulatory and QA support
Strategic consulting and operational support in a complex environment
Commercialisation and outcomes
Integrated solutions to accelerate market access and drive product adoption
Strategic resourcing
Customised FSP models to drive operational efficiencies and accelerate clinical development
Master protocol designs
Often, therapies are developed and tested in isolation rather than simultaneously for multiple related diseases. However, this framework is suboptimal for obesity and its interconnected conditions and comorbidities. Master protocol designs can create efficiencies in drug development for these interconnected therapeutic indications. ICON offers design, simulation and execution of adaptive and innovative clinical trials, including basket, umbrella and platform protocols.
Early phase obesity studies
ICON has proven success designing, managing, and executing early phase obesity studies enrolling overweight and obese volunteers. With a robust database of overweight/obese volunteers across our clinical research units we can rapidly meet key eligibility criteria and study milestone timelines. Over the last five years we have successfully achieved or exceeded enrolment targets across more than 35 early phase studies, with 95% retention rates, even for very long duration trials with multiple overnights and long follow-up periods.
Feasibility and site selection
Obesity clinical trials are usually long and complex, so it can be hard to accurately estimate enrolment and study timelines. To address this challenge, ICON has developed and licensed industry-leading tools to support all aspects of feasibility and site identification. With ICON’s award-winning AI-driven data aggregation and analysis platform, licensed partner data can be integrated with ICON performance data to predict which sites have the highest probability to enroll subjects.
Patient recruitment and retention
- Patient access continues to be one of the biggest industry challenges, impacting time and cost in clinical trials. ICON's FIRECREST Pre-Screen solution improves the speed and accuracy of the pre-screening process compared to other current paper-based and eScreen methods. The data harvested from the process is aggregated to form actionable insights into the key drivers of pre-screen success and failure.
- Working relationships with thousands of cardiovascular investigative sites across the globe helps tailor recruitment strategies to each study.
ICON uses a patient centric approach to provide study specific patient recruitment and engagement strategies on a global basis.
Patient-centric trials
Increasing patient centricity in clinical research is bringing benefits to both patients and sponsors. ICON provides Site & Patient Solutions that make it easier for the site and the patient to actively participate in a trial - an essential part of increasing predictability in enrolment and retention.
- Decentralised obesity clinical trials enhance patient experience, retention and compliance rates by connecting, monitoring and engaging patients at every step of the clinical trial journey with customised support service. ICON is already deploying decentralised clinical trials on a global basis in multiple therapeutic areas and will support you in navigating assessment, planning and execution for better outcomes.
- Digital health technology can support compliance and patient retention in obesity clinical trials. Our dedicated medical device and digital health technologies teams support device selection and digital endpoint validation.
- Accellacare is ICON’s global clinical research network offering customers a wide range of stand-alone and integrated solutions for their studies, including patient assessments at our sites or in-home to reduce site and patient burden.
- Using digital patient recruitment and removing barriers, such as travel and complex trial logistics, increases access to diverse patient populations and underrepresented communities.
Cardiac Safety Solutions
Cardiac safety is a key component of any drug or device clinical trial, with regulatory authorities requiring sponsors to demonstrate cardiac safety for all drugs. The collection and reporting of high-quality data is therefore essential to drive decisions across all phases of drug development.
ICON offers a range of end-to-end cardiac safety services, including electrocardiography (ECG), event monitoring, blood pressure monitoring (BPM), long-term Holter monitoring, echocardiography (ECHO) and multi-gated acquisition scan (MUGA) studies. Our highly experienced team includes medical doctors, board-certified cardiologists, cardiovascular research scientists, and expert cardiac consultants who will support every aspect of your trial, including protocol design, statistical analysis, expert report writing and communication with regulatory agencies.
Medical Imaging
ICON provides end-to-end integrated solutions based on the science of imaging biomarkers via cutting edge technology and image analysis tools. We have medical imaging expertise with specialisations in multi-modal image acquisition (MRI-PDFF, MRE, CT, DXA) and processing expertise in MASH and obesity assessments. Our core team of more than 450 qualified clinical imaging professionals includes radiologists, imaging scientists, and certified imaging technologists. These highly trained and experienced experts will provide advice on imaging endpoints and the critical uses of imaging for the medical, scientific and regulatory aspects of your trial - enabling improved decision making and successful outcomes.
Data-driven solutions for commercialisation
Achieving regulatory approval is no longer enough to ensure commercial success. ICON supports commercial positioning with consulting and with Symphony Health, our integrated health data liquidity and analytics. Symphony Health supports an Integrated Dataverse (IDV®), one of the largest integrated repositories of healthcare data, which provides comprehensive coverage of pharmacy prescriptions and claims, medical claims, and institution claims and sales. Through cloud-based solutions and consulting services, sponsors gain a more holistic view of how payer, prescriber, and patient behaviour impact brand success.
Post market follow-up
The only way to prove the true value of a medical device or therapy is to collect real-world data (RWD) on its safety, efficacy and cost outcomes outside of the clinic. Long-term data is especially important for information on duration of treatment and dosage of new drugs. ICON’s tokenisation and real world data capabilities make this post market follow-up possible.
Obesity insights
ICON's therapeutic experts provide analysis including whitepapers, blogs and contributions to media and industry conversations relating to clinical trials for obesity and other interrelated conditions.