Reimagine clinical trials with open approaches and interoperability

Read about our open technology philosophy and how it could increase patient engagement.

By and Sébastien Bohn | 8 minute read | June 8, 2020

If you’re a clinical trial executive involved in any aspect of trial design, it’s likely in the past few years you’ve faced a new dilemma — and not the one associated with how to run trials in a COVID-19 world. You’re collecting more patient data than ever before, which is good, but your ability to fully leverage the insights derived from that data is being hampered. The culprit? Those very same data collection systems you put in place years ago.

Whether it be your CTMS, CDMS, RBM, ePRO, or any of the other various applications that constitute your clinical trial ecosystem, there’s a good chance that some data silos exist. Some people may say that lack of integration amongst certain programs is just the cost of doing business, or they may incur actual costs for customized programming to connect disparate systems. But these days, isn’t the goal to trim clinical trial expenses while also increasing the speed at which trials are designed and conducted?

“In the past year, we’ve observed a trend where pharma companies and CROs are recognizing that they are not getting as much value out of their clinical trial systems, especially when you consider the tremendous advances in technology we all enjoy today,” says Mary Varghese Presti, VP, Life Sciences, Watson Health at IBM. “A clinical trial generates huge amounts of data, often on a global scale. But is all that data accessible and actionable by the sponsors of those trials? Or, is much of the data trapped in silos of closed solutions?”

An open and connected philosophy

Any discussion of a solution to this industry problem is usually peppered with terms such as “open,” “interoperable,” “integrated,” and most simply — “connected.” On the surface, these are vague, which only adds to the trepidation associated with changing or adopting any new software application. Thus, it’s important to quantify any of these terms when they are applied to clinical trial technology. For instance, there’s a big difference between an EDC being able to connect to a CTMS and one that makes connecting extremely easy with no programming skills necessary. “Often you’ll hear a company say, ‘We have some APIs, so yes, we should be able to integrate.’ But then the sponsor or CRO is tasked with figuring out how to exchange data between the two programs when they don’t speak the same language or when data are not in the same format,” explains Sébastien Bohn, Offering Leader for IBM Clinical Development.  “Those ‘connections’ are not built-in, so this becomes a very frustrating and time-consuming project that actually decreases the effectiveness of the technology and requires custom development.”

That common pain point is what led IBM to build point-and-click data mapping into its IBM Clinical Development CDMS. To maximize the effectiveness of this functionality, an interface was created with a simple design that enabled any user — not just those with programming experience — to easily map data going in and out of the program. So far, the application has a standard interface to pull in external data and/or expose data to external systems. On top of it, IBM developed and maintains out-of-the-box connectors with various other clinical trial-related solutions and CTMSs (e.g., BSI, Veeva). “Our approach is that it doesn’t really matter what type of system — CTMS or otherwise — we have on the other side,” says Bohn. “We are open because you can easily bring in multiple types of trial data that originate outside of our system. We are connected because we deliver a set of out-of-the-box interfaces to a set of partner applications. Since that connectivity is already built-in, you don’t have to pay for any bespoke integration or external development [see sidebar].” Usually this data mapping would be done in a spreadsheet by a data manager or whomever is creating the case report form, and then it would be programmed by a developer for each clinical trial.

Aside from cost savings, these kinds of open systems save time, too. For example, say the code values for male and female differ between the EDC and CTMS (a common problem). If the EDC is pushing out a “1” for female and a “2” for male, but the CTMS is expecting an “F” or “M”, the import isn’t going to make sense, so a level of rework will need to be done. But by using the advanced expression editor included in IBM Clinical Development, you can format or transform the data you just mapped on the fly. Before the data reaches the external system, you can transform it, again, via simple point-and-click functionality, and thereby avoid any lost time.

“Having this kind of simplified integration can directly impact how fast you can start a study,” add Bohn. “Think about integrating a CDMS with an eConsent application, for instance. Since eConsent is one of the first things you have to do for a study, until those two systems are talking to each other, the study can’t get started. There’s also the peace of mind that a CRO, for example, has when it knows that the two systems are already set up to talk to each other without the need for costly configuration.”

Don’t overlook the value of choice

The COVID-19 pandemic has caused sponsors and CROs, and the vendors that support them, to consider new ways of improving clinical trials. Consequently, many pharma companies are reevaluating their clinical trial technology infrastructures and trying to identify what systems are holding back progress. These are the applications that have created a burden on the company by forcing the creation of complicated and sometimes costly workarounds. The staff’s comfort level with using these systems often disguises the need for improvements. The general consensus is that making a change would be too difficult even if the benefits of doing so are evident.

Varghese Presti says she’s heard this sentiment before. A company feels “locked in” to a solution because of the time and money they’ve invested. They’re committed, and their choices of improving or altering the system are limited or nonexistent. “When explaining our ‘open’ philosophy, I always feel the need to mention Joy’s Law, which posits, ‘No matter who you are, most of the smartest people work for someone else.’ After all, you cannot be everything to everyone. So, you want an approach where you can still benefit from connecting to ‘the best.’ Thus, we are always looking to partner with other companies whose applications, when seamlessly connected with IBM Clinical Development, provide the sponsor an ultimate set of choices. Of course, we can’t connect to every company’s applications, but because we have this open approach, we are always looking for other companies that have the same philosophy, the same desire to simplify all aspects of trial design and make it easy for everyone to use the system.”

Transparency in pricing

The idea of “being open” can apply to a company’s pricing practices for clinical trial technology, too. After some extensive market research, Varghese Presti says IBM learned that pricing is incredibly opaque in this market; many vendors have large price tags for these applications and the associated work, but it’s not entirely clear what is included. “The pricing for IBM Clinical Development follows our philosophy of giving clients a choice,” she explains. “First, it’s extremely transparent; we offer pay-as-you-go and subscription models, and it’s not confusing why our price is what it is. But we also derisk your ability to choose us because you don’t have to make an up-front capital investment by using our SaaS model.”

As examples, she says a Big Pharma with a large volume of data being generated from multiple studies would likely want a predictable bill each month, making it easier from an accounting perspective. A small biotech, on the other hand, with limited funding and the operationalization of a few studies at a time would be better suited for the pay-as-you-go option. Having this knowledge up front when deciding on a CDMS, for instance, helps alleviate the concern about making this kind of investment or technology change.

Increase patient engagement

Any discussion of changing a legacy CDMS or ePRO should go beyond just the interoperability and open nature of the application. Its ease of use, especially for patients, must be a major consideration.

Recently, IBM Watson worked with a CRO that conducted a flu study using IBM Clinical Development as its ePRO. Because of the solution’s simplicity and easy-to-understand interface, thousands of patient data entries were made every day for a month straight. “That kind of patient engagement is extremely valuable to any trial,” says Bohn. “But equally important is the fact that the CRO was able to view that data in real time via one system — our CDMS — that incorporates ePRO and EDC. There was no waiting for batches to be pulled, they could analyze the data — and make changes if necessary — much faster.”

As pharma companies and CROs around the world continue to adapt to running trials in this new COVID-19 environment, they are taking this time to reassess the status quo of their technology installations. It’s times like this that you can really delve deep into assessing how “open” or “interoperable” a system really is. “With IBM Clinical Development, we’re creating a unified platform that is not only open but a force multiplier on the ROI of the technology investments a sponsor makes for clinical trials,” says Varghese Presti. “For example, say you’re going to spend 2 percent of your technology budget on IBM Clinical Development and 98 percent on everything else. That 2 percent spend on our CDMS will give you greater return for your spend on everything else if it works to connect and allow data to flow.”

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