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Cloud on the horizon: Cloud computing and the clinical trial

Published on 01/09/16 at 10:20am
 

Originally published in the September edition of Pharmafocus, Matt Fellows investigates how cloud computing may just be the answer the industry is looking for to cope with the increasingly unfeasibility of clinical trials.

Clinical trials remain an essential cornerstone of the pharmaceutical industry, and are crucial in the development and assessment of any medical breakthrough. But as the industry moves forward and technology continues to evolve, the practice is beginning to increasingly show its age; exorbitant financial drains and time expenditures have begun to outstrip the payoffs of performing trials, rendering them ineffectual or simply unfeasible.

With multitudes of necessary expenses ranging from administration, recruitment, materials and personnel to data collection, management and analysis, the investment which pharmaceutical companies and biotechs must make is a risky and potentially fatal one. In the US in 2014, clinical trials across all therapeutic areas cost $30-40 million on average before approval in Phases I-III and a comparable sum post-approval in Phase IV. The total cost to implement and monitor a large-scale trial can be anywhere between $300 and $600 million, with the total cost increasing by a few million each year. In January 2012, Forbes calculated that the average cost of bringing a new drug to market, including failed drug applications costs, was $1.3 billion; it has been further estimated that pharma companies can lose from $1-8 million in daily revenue as a result of a product being absent from the market.

On top of the financial costs, it can also take 6-12 months to initiate a global Phase III trial, with participant recruitment taking another 12 months or sometimes even longer; research conducted at the Tufts Center for the Study of Drug Development pins the average development time for clinical trials at 6.7 years. So when the price of entry is so high, how can companies mitigate the financial damage and keep this essential practice viable? Many industry figures are already pointing to an answer: the cloud.

What is the cloud?

Cloud computing is, essentially, the on-demand management of data stored on a centralised network of remote virtual or internet-based servers, as opposed to local servers or PCs. The service is on-demand and self-service on a pay-for-use basis, providing a scalable resource that allows users to store large quantities of data in a singular, convenient and connected location, ready to be easily accessed from any online device. Without the need for physical servers, hardware costs are eliminated, while its streamlined operation saves countless valuable hours.

Currently one of the more notable technologies in the IT industry, the cloud computing market grew 28% to revenues of $110 billion in 2015 according to the Synergy Research Group, while the International Data Corporation predicts that worldwide spending on public cloud services will grow from around $70 billion to over $141 billion by 2019 – a rate nearly six times the overall IT spending growth.

With the current investment woes surrounding clinical trials, you’d expect a potentially liberating technology like this to be heralded as a knight in shining armour. But the industry has always been slow to adopt new and innovative technology; public cloud use is already moderately common in clinical trials, but primarily for administrative, IT, marketing or sales purposes, and much more rarely is its use directly related to life science.  But the benefits of the technology as a solution for the increasing strains cannot be understated.

From a monetary standpoint, hardware expenses are vastly reduced by eliminating the need to purchase or rent storage space or power and maintain servers, alongside the added bonus of flexible scalability to meet increases and decreases in demand, minimising wasted resources throughout the duration of a trial. Research from technology giant IBM has indicated that many life sciences organisations could reduce their annual operating expenditure as much as 25% on clinical IT systems by utilising cloud technology.

The technology also facilitates much more efficient processes during trials, helping to save precious working hours. By acting as a single centralised repository for all aggregated records, research and documents, information only needs to be entered once and can then be accessed anywhere via a single logon, streamlining all data handling with simple user-friendly operation. Furthermore, this centralised resource ensures all users are utilising the latest data versions and enables quick and accurate auditing when necessary. With some trials spanning multiple sites and incorporating the data of thousands or even tens of thousands of remotely monitored participants, this helps to simplify complex logistics and expedite better collaboration between research sites, minimising inefficiencies and abolishing redundant processes. All these operational benefits can help to shave months off the duration of a clinical trial.

Cloud computing

A winning partnership

One company that is showing no hesitation in reaping these benefits is Dublin-based clinical research firm Icon, a provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company has forged an alliance with IBM to take advantage of its Watson computer system, a technology platform capable of using natural language processing to collate and reveal insights from large quantities of unstructured data.

Among other key advantages, Icon will benefit from the Watson Health Cloud, which facilitates simple access to a vast magnitude of patient data that can be de-identified, shared and added to an ever-growing body of clinical research data. Fiscal costs and timelines of patient recruitment have the potential to be vastly diminished; it’s estimated that, per year, patient recruitment costs alone can reach more than $1billion – a prohibitive weight on the shoulders of any prospective trial and one which Icon's chief operating officer, Steve Cutler, knows all too well:

"Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30% of total study costs," he explains. "By applying IBM Watson to our clinical trials, we have the potential to revolutionise clinical trial feasibility, patient recruitment and study start-up timelines.”

IBM itself is under no illusions over the importance of clinical trials for the development and accessibility of vital products. In the face of obstacles stemming from an increasingly obsolete model, the company understands the value that cloud computing can bring to the industry, as Sean Hogan, vice president and general manager for IBM Healthcare notes:

“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. 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.”

Keeping things secure

The potential benefits don’t stop at savings in time and money either. One of the biggest advantages that the technology can offer to the industry is the security it can bring to patient data. With data theft on the rise in hospitals the issue is of great concern to clinical professionals, and cloud services offer a comprehensive multi-layered portfolio of managed security services to keep patient information safe.

In addition to safety from hacking, the technology also delivers protection against unforeseen tragedies such as power outages, natural disasters, sabotage and other threats to data integrity by providing backup and recovery of vital information. This would drastically set back a trial should it be irrevocably lost.

And most excitingly, with advances in wearable and smart phone technology, the cloud can help tap into these new tools to open up more direct avenues of data collection from clinical trial participants, further streamlining operation and eliminating unnecessary manual intervention.

Cloud storage

Cloudy forecast

Icon may be among the first wave of companies to embrace the technology in the industry, but the dream of mass adoption is not without its bumps in the road; there are a number of concerns over its implementation in the industry, which must be addressed before it can become the standard. Foremost among these is the issue of compliance; pharmaceutical companies must ensure that any providers conform to all necessary industry regulations. And with trials becoming increasing international, the same is true of local regulations dependent upon the country where the data is hosted.

Another concern is industry volatility. As cloud computing is a relatively new technology, competition in this sector could mean that some providers are knocked out of the market, and it is not clear how this would affect data access as it could prove difficult to migrate the information to another host.

Given these concerns and the lack of concrete feedback documenting deployment of the technology in the industry, it’s understandable why companies are hesitant to adopt it. But one thing is certain: the current model is unsustainable, and will only run into more problems as the needs of the clinical trial evolve. If the cloud is here to stay for the near future and brings with it such a wealth of obvious advantages, maybe it’s time for companies to take the leap?

Matt Fellows

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