Industry navigates clinical trials through cloud computing

Print 14 December 2015
Peter Winter / BioWorld

Cloud-based high-performance computing is beginning to prove its worth in drug development research. The next logical step is its application in modernizing the clinical trial process by making trial enrollment and management much more efficient.

The advantages of being able to quickly manage patient recruitment and the resulting mountains of data that accrue from clinical trials sites are just a couple of reasons cloud computing has started to appeal. And no wonder; it is estimated that biopharmaceutical companies spend more than $1 billion on patient recruitment alone each year. Also getting late-stage trials under way can burn up to 12 months – then enrolling the planned number of patients could add another year or longer to the timeline of drug testing.

Seeing an opportunity to help reduce those lengthy periods, a number of cloud computing data crunchers both large and small are rapidly entering the space.

IBM Watson, for example, launched last year, is hailed by the company as the first commercially available cognitive computing capability delivered through the cloud, which analyzes high volumes of data and complex questions posed in natural language and proposes evidence-based answers.

Its Health Cloud was unveiled in April and has already attracted Teva Pharmaceutical Industries Ltd. to be its first foundational life sciences partner, becoming the first global pharma company to tap into the power of the cloud.

From the massive amounts of personal health data being created daily, the Watson Health Cloud allows that information to be anonymized, shared and combined with a dynamic and constantly growing aggregated view of clinical, research and social health data that clients choose to share.

Teva explained that it selected the platform to deploy big data and machine learning technology to create disease models and advanced therapeutic solutions.

The company is "actively exploring the e-health evolution with a strong focus on fulfilling unmet and emerging patients' needs," noted Guy Hadari, senior vice president and chief information officer at Teva.

It plans to work with IBM on long-range platform and solutions development, with experts collaborating to enhance IBM Watson Health Cloud capabilities and explore synergies with existing Watson Health ecosystem partners.

CONNECTING PATIENTS

In an effort to connect patients to relevant clinical trials and support clinical trial recruitment, Dublin-based Icon plc said it is tapping 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.

Initially, it said it will apply Watson Clinical Trial matching to its breast, lung, colon and rectal cancer trials. The solution enables the firm to advise sponsors on how many patients match the trial criteria, where those patients are located and how they can be recruited. IBM's Watson Health Cloud will facilitate access to de-identified patient data, including 50 million patient records contained in the dataset from Cleveland Clinic spin-off Explorys, a health care intelligence cloud company acquired by IBM in April.

"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," explained Steve Cutler, Icon's chief operating officer. "By applying IBM Watson to our clinical trials, we have the potential to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines, he added.

PATIENT DATA: A VALUABLE COMMODITY

Cambridge, Mass.-based Infinity Pharmaceuticals Inc. is taking advantage of Medidata's Clinical Cloud for risk-based monitoring (RBM) in a phase III oncology study for patients with indolent non-Hodgkin lymphoma. Medidata, a global provider of cloud-based solutions for clinical research in life sciences, said Infinity has been a customer for almost a decade, utilizing the cloud-based technology for electronic data capture and management and medical coding across its preclinical and later-phase development programs. Infinity is leveraging the combination of technology and analytics within Medidata RBM to include centralized statistical analytics, targeted source document verification, and study and site level key risk indicators.

Risk-based monitoring allows clinical trial sponsors to identify and prioritize resources around key areas of risk, such as patient safety and data quality and integrity.

According to Medidata, the Clinical Cloud includes 8 billion clinical records from more than 2 million patients across more than 9,000 studies – a resource that is growing by more than 500,000 data points daily.

STARTING ON THE RIGHT FOOT

Earlier this month at its R&D Summit, Veeva Systems, of Philadelphia, which offers cloud-based software, released details of its fully integrated clinical trials study start-up solution. That will enable life sciences companies to manage both the content and the activities associated with activating sites for clinical trials.

Veeva reported that companies are continuing to adopt advanced solutions to increase speed and efficiency in many areas of the trial process. According to the 2015 Trial Master File (TMF) reference model survey, a majority of respondents (61 percent) are either using or actively planning on using an eTMF.

Vault study start-up is designed to bring together site start-up documents and site initiation in a single solution, while providing interoperability with the Veeva Vault eTMF. Sites, sponsors and contract research organizations will therefore be able to access the same clinical information, simplifying collaboration and processes, the company said.

While still early days, it is already clear that cloud computing will continue to evolve as a platform to improve the efficiency of clinical trials.

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