Silver linings:cloud-based technology for clinical trials26 July 2018
For pharma and biotech companies, cloud-based technology is poised to deliver simplicity and enhanced sponsor-provider relationships to the costly and prolonged clinical trials process. Neil Thompson speaks about the promise and perils of these technological solutions with Abel Archundia-Pineda, global head of IT at Bayer’s pharmaceuticals division, and Steffen Roellinger, senior vice-president of global development for portfolio and operations at the company’s pharmaceuticals research and development branch.
Cloud computing now allows people and applications to access or process data from virtually anywhere. This is causing a critical shift within the clinical trials process, argues Abel Archundia- Pineda, Bayer’s global head of IT within its Pharmaceuticals division. “The advantages are evident,” he says. “[With this technology] you can better manage the size of your own infrastructure, and it’s easy to scale up, compute or reduce storage capacity when needed.”
Rather than having to put hours of work into overseeing a trial, Bayer and companies like it can now get their in-house experts to concentrate on value-creating strategic topics, like analytics or artificial intelligence, to get more insights out of the data gathered. This new digital revolution is shaking up the priorities of the clinical trials sector as it comes of age.
Getting good cloud systems set up anywhere used to be a hard, timeconsuming process, according to Archundia-Pineda. It was especially difficult in his industry because of the high bar set for performance, security and data privacy in the life sciences. But today, cloud solutions are becoming commonplace, even within the clinical trials process.
Archundia-Pineda lists examples such as Accenture’s Life Science Cloud, an industry platform for running clinical trials that Bayer is currently managing.
The company also uses a cloud-based solution for checking its compliance with industry data standards prior to agency submission. Government agencies such as the FDA use the same tool to check the submitted data, which makes life easier for both sides.
“Cloud-based technology is already building fundamental pillars for global communication and are becoming more and more important for global cooperation,” states Steffen Reollinger, senior vide-president of global development for portfolio and operations at Bayer’s pharmaceuticals research and development division.
“The pharmaceutical industry used to be more hesitant, but we are seeing the first examples of this kind of collaboration, such as the Project Data Sphere platform, which provides one place where the research community can broadly share historical, patientlevel data from academic and industry phase III clinical cancer trials.
Another example is the global Internet of FAIR Data & Services, which provides a common environment for data-driven research and innovation.”
In fact, Reollinger and Archundia- Pineda are keen to stress that cloudbased applications are becoming an absolutely integral part of the clinical trials process.
More and more applications are moving into the cloud due to the flexibility and scalability inherent in its functions.
Meanwhile, cloud-based technology is frequently being used to build hubs that can efficiently digest and process the increasing amount of data streams being produced by devices and wearables.
Only they can handle the continuous flow of information such gadgets create over prolonged periods once activated.
The surge of interest in this area is fuelling a debate over the best way to design their structures; broadly speaking, this means choosing between a multitenant or singletenant design for a platform.
“The multi-tenant cloud is an architecture in which a single instance of software serves multiple customers. In the multitenant cloud, many customers share computing resources and storage, and run on the same application, but the data of each software instance are protected by definitive access points and security features,” Archundia-Pineda explains.
“Since resources are shared and maintained externally, the cost to each tenant is reduced. Moreover, new features and solutions don’t have to be reinvented by every single company. This also helps to save time and money.
“The main advantage of a singletenant solution [by contrast] is that it can be customised to individual needs. There may also be a higher level of control over the pace at which features evolve. It can be adapted to specific data privacy rules – like the ones we have in the EU, for example – more easily.
– Steffen Reollinger
“While the customer does benefit from not having to manage the solution directly or worry about the hardware involved, this solution often cannot provide the economies of scale that multitenant deployments can provide.”
Both types of system are useful, though the threats to intellectual property and patient privacy from hackers always meant that not every solution in the industry could ever be as open as a multitenant system.
But having a single tenant, Bayermanaged system such as Accenture’s Life Science Cloud provides the company with more than just a higher level of security: it also allows Bayer-specific set-ups, such as the integration of software tools the company has developed for its own use.
“For clinical trials, we’re using a mixture of Bayer-specific and standardised [networks],” says Reollinger. “The latter allow the sharing of the costs and risks of new functionalities between industry partners. Compliance risks in particular are reduced with standard platforms.”
Safer, better, cheaper
When asked about how safe such developments are for participants and their private data, Archundia-Pineda is firm. “At Bayer, we take risk assessment very seriously; that’s why we’re assessing not only the vendors but also the specific solutions in regards to security, data privacy and such,” he says. “Especially if you’re dealing with very critical patient data, compliance with the highest standards is needed.
“From a validation perspective, cloudbased applications can reduce our burden because vendors can provide much of the evidence required for customers to pass audits.”
Of course, the arrival of new IT advances has always created opposition. But in the future, both men expect complex clinical trial studies with patients connected in real time to have become the norm, though Archundia-Pineda cautions that these will all require secure cloud-based electronic data capture systems first.
Ripe for change
Clinical trials are often multi-site studies that last for a long time and generate vast amounts of data; in other words they are ripe for a change that accomplishes their aims in less time and with less effort than a manual, paper-based process.
Cloud solutions make it much easier to process, analyse and evaluate masses of data – and to share the results with a trial’s stakeholders, who can be spread across the globe thanks to modern communications.
The commercial and practical implications of the cloud are hard for businesses to resist, even if they wish to avoid arousing social controversy.
Archundia-Pineda thinks the promise of the cloud makes it an exciting time to be involved in medical research. “By using cloud solutions, we hope to achieve [many things in the future] by combining numerous approaches and technology, such as trial simulation, decentralised clinical trials, automated data capture through devices and wearables, pattern recognition predicting responses to a new medicine, replacing placebo arms by in-silico modelling based on real-world data,” he says.
“Science for a better life is our purpose; what’s really at stake is how this technology contributes to the health of our patients and our positive impact on society.”
– Abel Archundia-Pineda
Time and money
Moreover, faster processes and better information capture are important advantages anywhere, but especially so as far as the pharmaceutical industry is concerned.
“A really large phase-III trial, for example in heart failure, has something like a three-digit million price tag. But in our business, time savings often [even] outweigh financial savings,” Reollinger explains.
“If you can save a couple of months in development time, you earn this time in peak sales. Therefore, speed is important.
“But just as important are improved patient outcomes: faster delivery of better therapies to the individual patient. In other words, precision medicine that will benefit the patients and result in better business results.”