Catching Up With The Consumerization Of Technology In The Clinical Trial World

By Eric Silberstein, CEO, TrialNetworks

Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.

At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.

The phrase “consumerization of technology” refers to innovation that begins in the consumer world and then spreads to a business environment. One recent phenomenon is the iPhone replacing the Blackberry as the gold standard business mobile connectivity tool. This change was driven largely by executives who preferred using Apple devices at home pressuring their internal IT organizations to make the switch on a corporate level as well.

Pharmaceutical companies are not typically known for being early adopters of technology, and for good reason due to patient safety and regulatory concerns. However, online and intuitive technology is now so pervasive in the consumer world  the previous generation of collaborative and management tools have become noticeably dated and in many cases obsolete. As a result, the consumerization of technology is  beginning in the clinical trial world, and a new breed of technology providers is bringing common sense consumer-like capabilities to help improve the efficiency and quality of clinical trial operations.

Consider Renee, a clinical trial manager and a mother. In her personal life, she stays in touch with friends through social networking and video chat, easily finds information she needs with robust search features, manages invitations and tracks RVSPs to her kids’ birthday parties using online services, and utilizes shared tools such as calendars, discussion groups and spreadsheets to coordinate schedules with her husband and her volleyball team. And she does all of this from her laptop, tablet or phone.

In Renee’s professional life, by contrast, the analogs of each of these activities are carried out using slow, manual and old-fashioned processes. It is only natural that she wonders why she can instantly connect with college friends around the world but it takes several days and layers of people (such as regional project managers and CRAs) simply to get a message out to her sites. Tracking of anything—acceptances to an IM, progress towards site startup, screening progress—is never straightforward and always seems to involve people, spreadsheets and time. As technology continues to make things easier in her home life, it increasingly highlights the redundancy, inefficiency and frustration of her work.

Renee and her peers in clinical operations are ready and willing for a change – and that change is coming with a new technology platform called the Clinical Trial Optimization System.

What is a Clinical Trial Optimization System?

A Clinical Trial Optimization System is a cloud-based suite of collaborative apps and investigator site tools hosted in a single unified interface. It enables sponsors, sites and CROs to run faster, higher quality and more efficient clinical trials.

The platform has its roots in CTMS and investigator portals, but has branched out from these early predecessors in its scope, scale and usability. Unlike CTMS, it brings key stakeholders in the trial together, with access by sponsor teams, site staff, vendors and CROs. It provides a broad range of tools which are integrated with one another as part of a comprehensive clinops solution from startup through closeout. And just as important, its design is inspired by modern and flexible consumer applications which remove hurdles of adoption and ensure intended users want to use it – because it’s intuitive, easy to learn, and makes their jobs easier.

How Does the Technology Help?

Running a clinical trial entails coordinating many intricate processes. During the startup phase, these processes focus on assessing feasibility, selecting sites, and global activation. As the trial progresses into execution much of the effort shifts to ensuring appropriate monitoring, engaging sites to improve enrollment and retention, and ensuring proper training.

One common element of all of these processes is that they involve many groups (sites, CRO, sponsor, other vendors), with numerous detailed steps and regional variation. Another attribute they share is  surprisingly little automation:the burden is shouldered by many people using many spreadsheets.

A Clinical Trial Optimization System provides a portfolio of collaborative tools and trial management apps designed to automate workflow and online tracking for each of these processes. The system is used by sponsor, CRO and sites to ensure quality and efficient monitoring and project management for key aspects of every clinical trial: process, communication and training.

Process: Ensures tasks are completed properly and on schedule – for example, site activation and database lock.

Communication: Streamlines communication of information to sites and global project team members and engages sites to motivate enrollment, retention and quality goals.

Training: Improves compliance through online training, tracking and site-friendly reference tools.

With all of the moving parts and pieces in a clinical trial, if one small thing goes wrong the timeline to completion can extend by a month – and each day of delay is an extremely costly proposition. A Clinical Trial Optimization System reduces the chance of delay, enhances efficiency and ensures quality through consistent communication, oversight and engagement.

Clinical Trial Optimization Systems are implemented by clinical study sponsors and CROs running Phase I-IV clinical trials, ranging from hard-to-recruit studies with 20 sites that require enrollment and engagement support to massive global megatrials with 20,000 patients at 1,000 sites that need a way to keep their study team informed, trained and performing at a superior level.

Real-World Results

Perhaps due to previous experiences using older clinical systems sponsor, site and CRO staff are often skeptical of new technology – but begin to change their impressions when the tools have the same flexibility and modern design as the apps they use at home. Such intuitive technology is merely a means to an end, and full adoption occurs as tasks become easier and the individuals running clinical trials see results.

For example, a selection of benefits realized by customers utilizing the TrialNetworks platform include…

• Patient Recruitment: Using increased communications, virtual “achievement” badges and friendly competition leaderboards, Infinity Pharmaceuticals was able to triple enrollment from one month to the next by implementing 30-day recruitment challenges which engaged sites, rewarded achievements, and encouraged friendly competition.
• Site Feasibility: By implementing structured surveys that make it easy for sites to respond, ARIAD Pharmaceuticals received an unprecedented 75% survey response rate (50% is the gold standard) from 300 global potential sites – all with complete, legible and logical data. Because the survey app integrates with the startup checklist app, selected site benefitted from a head start for faster activation.
• Patient Retention: An innovative tool to identify patients at risk of dropping out of the study combined with online site training enabled a Top 10 pharmaceutical sponsor of an event-driven cardiovascular megatrial to reclaim more than 1,000 subjects who had previously dropped from the trial – while minimizing the number of patients becoming lost to follow-up and withdrawn consent.
• Site Activation and Database Lock: Leveraging checklist mechanics, due dates and reporting – instead of inconsistent Excel spreadsheets that were out of date by the time of the weekly vendor call – all activation and database lock activities were completed on time while reducing the time the sponsor’s study team spent managing these initiatives by 20%.

Summary

As the individuals who run clinical trials have become accustomed to modern and intuitive tools which improve their daily personal lives, they are demanding access to similar technology in the clinical trial environment. Whether at the sponsor, CRO or site this consumerization of technology is speeding adoption of new solutions such as the Clinical Trial Optimization System – a unified and comprehensive platform for cloud-based apps designed to transform the quality and efficiency of clinical operations. Tangible results in key aspects from startup through closeout – including site feasibility and activation, patient enrollment and retention, training and document management – will greatly benefit the industry as more sponsors learn about the advantages these new technologies provide.

About the Author

Eric Silberstein is CEO of TrialNetworks (Needham, MA), a company he co-founded together with CTO Ezra Freedman and U.S. Surgeon General nominee Dr. Vivek Murthy. TrialNetworks provides sponsors and CROs with a comprehensive Clinical Trial Optimization System to transform the quality and efficiency of clinical trials from startup through closeout. He can be reached at esilberstein@trialnetworks.com.

Contact: Brenda Nashawaty, Brenda@nashawaty.com, 617-688-3253