Taking time and money out of clinical trials

ICON and IBM plan to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines

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DUBLIN, Ireland—ICON plc, which just celebrated its 25th anniversary as a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, is partnering with IBM to help reduce the time and costs of drug development, while also offering patients enhanced quality of care by connecting them to relevant clinical trials. ICON will tap Watson’s cognitive computing power to help automate the cumbersome process of identifying patients who meet the criteria for a clinical trial, and to analyze protocols to assess trial feasibility and identify optimal trial sites.
 
ICON’s chief operating officer, Dr. Steve Cutler, says it’s too early to estimate what reductions in time and cost might be achieved, but he expects them to be “substantial” and says that the pilot program “will tell us much more.”
 
Initially, ICON is applying Watson Clinical Trial Matching to its breast, lung, colon and rectal cancer trials. The solution enables ICON to advise sponsors how many patients match their trial criteria, where they are located and how they will recruit them. IBM’s Watson Health Cloud will facilitate access to de-identified patient data, including 50 million patient records contained in the data set from Explorys, which IBM acquired in April. At the same time, ICON enhances IBM Watson’s capabilities by providing expertise into clinical trial protocols and clinical operations.
 
Cutler notes that Watson’s cognitive learning skills will allow it to recognize oncological terms and data and to read unstructured data. “Watson can also use OCR technology to read doctor’s notes and apply inclusion/exclusion criteria,” he observes. “Doctors can make decisions while the patient is in front of him or her.”
 
The cost and time involved in clinical trials is considerable. More than $1.3 billion is spent on patient recruitment by drug developers each year, and yet fewer than 5 percent of cancer patients participate in a clinical trial. It also typically takes six to 12 months to start up a global Phase 3 drug trial and another 12 months to enroll the required number of patients.
 
Watson, it is hoped, will expedite the process. Watson Health Cloud contains records from nearly 100 million patients coming from multiple healthcare providers. It draws on a wide variety of data about each patient, including symptoms, genomic data, test results, diagnoses, treatments and outcomes.
 
Cutler adds that “Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30 percent of total study costs. By applying IBM Watson to our clinical trials, we have the potential to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines, which will help our customers take significant time and cost from their development programs. Together with IBM, we are also providing a better and faster way to connect patients with clinical trials that are most relevant to them. [This] announcement is an excellent example of disruptive innovation and represents ICON and IBM’s shared vision for using industry-leading technologies and real-world data sets to improve clinical development.”
 
“Clinical trials are crucial in the drug and treatment development process, but when it comes to identifying appropriate trial candidates, there are significant data challenges, which can contribute to delays for bringing new therapies to market,” according to Sean Hogan, vice president and general manager of IBM Healthcare. “Through cognitive computing and cloud-based data, our goal is to help our clients accelerate the time it takes to complete clinical trials and reach conclusive trial results.”
 
Watson is the first commercially available cognitive computing capability that is said to represent a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, understands complex questions posed in natural language and proposes evidence-based answers. Watson continuously learns, gaining in value and knowledge over time from previous interactions. In April 2015, the company launched IBM Watson Health and the Watson Health Cloud platform. The new unit will help improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud allows this information to be de-identified, shared and combined with a dynamic and constantly growing aggregated view of clinical, research and social health data.
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development—from compound selection to Phase 1-4 clinical studies. At any given time, the company supports 120 to 130 oncology trials simultaneously. With headquarters in Dublin, Ireland, ICON currently operates from 81 locations in 37 countries and has approximately 11,300 employees.
DUBLIN, Ireland—ICON plc, which just celebrated its 25th anniversary as a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, is partnering with IBM to help reduce the time and costs of drug development, while also offering patients enhanced quality of care by connecting them to relevant clinical trials. ICON will tap Watson’s cognitive computing power to help automate the cumbersome process of identifying patients who meet the criteria for a clinical trial, and to analyze protocols to assess trial feasibility and identify optimal trial sites.
 
ICON’s chief operating officer, Dr. Steve Cutler, says it’s too early to estimate what reductions in time and cost might be achieved, but he expects them to be “substantial” and says that the pilot program “will tell us much more.”
 
Initially, ICON is applying Watson Clinical Trial Matching to its breast, lung, colon and rectal cancer trials. The solution enables ICON to advise sponsors how many patients match their trial criteria, where they are located and how they will recruit them. IBM’s Watson Health Cloud will facilitate access to de-identified patient data, including 50 million patient records contained in the data set from Explorys, which IBM acquired in April. At the same time, ICON enhances IBM Watson’s capabilities by providing expertise into clinical trial protocols and clinical operations.
 
Cutler notes that Watson’s cognitive learning skills will allow it to recognize oncological terms and data and to read unstructured data. “Watson can also use OCR technology to read doctor’s notes and apply inclusion/exclusion criteria,” he observes. “Doctors can make decisions while the patient is in front of him or her.”
 
The cost and time involved in clinical trials is considerable. More than $1.3 billion is spent on patient recruitment by drug developers each year, and yet fewer than 5 percent of cancer patients participate in a clinical trial. It also typically takes six to 12 months to start up a global Phase 3 drug trial and another 12 months to enroll the required number of patients.
 
Watson, it is hoped, will expedite the process. Watson Health Cloud contains records from nearly 100 million patients coming from multiple healthcare providers. It draws on a wide variety of data about each patient, including symptoms, genomic data, test results, diagnoses, treatments and outcomes.
 
Cutler adds that “Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30 percent of total study costs. By applying IBM Watson to our clinical trials, we have the potential to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines, which will help our customers take significant time and cost from their development programs. Together with IBM, we are also providing a better and faster way to connect patients with clinical trials that are most relevant to them. [This] announcement is an excellent example of disruptive innovation and represents ICON and IBM’s shared vision for using industry-leading technologies and real-world data sets to improve clinical development.”
 
“Clinical trials are crucial in the drug and treatment development process, but when it comes to identifying appropriate trial candidates, there are significant data challenges, which can contribute to delays for bringing new therapies to market,” according to Sean Hogan, vice president and general manager of IBM Healthcare. “Through cognitive computing and cloud-based data, our goal is to help our clients accelerate the time it takes to complete clinical trials and reach conclusive trial results.”
 
Watson is the first commercially available cognitive computing capability that is said to represent a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, understands complex questions posed in natural language and proposes evidence-based answers. Watson continuously learns, gaining in value and knowledge over time from previous interactions. In April 2015, the company launched IBM Watson Health and the Watson Health Cloud platform. The new unit will help improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud allows this information to be de-identified, shared and combined with a dynamic and constantly growing aggregated view of clinical, research and social health data.
 
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development—from compound selection to Phase 1-4 clinical studies. At any given time, the company supports 120 to 130 oncology trials simultaneously. With headquarters in Dublin, Ireland, ICON currently operates from 81 locations in 37 countries and has approximately 11,300 employees.


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