What’s been proven to reduce data variance, increase patient compliance and decrease site monitoring costs in clinical trials? For certain, it’s not the continued use of paper records. Digitization of clinical trial processes is the driving force behind real ROI and its demonstrated results are increasing the adoption rate among sites and sponsors. In market research conducted in 2012, sponsor companies reported using EDC in roughly two thirds of their Phase 1-4 trials. In 2015, that had risen to 90%.1
The use of newer technologies such as electronic clinical outcomes assessments (eCOA) are also on the rise. In a 2015 survey of 115 clinical research professionals, respondents indicated that only about half of studies with Patient-Reported Outcomes were using ePRO. But they overwhelmingly agreed that this was expected to increase. These trends require sponsor companies to mitigate the need for disparate data collection systems and streamlining the end-to-end processes that make a trial run smoothly; its use is safeguarding trials from garnering expensive and complex data that turns out to be invalid.
True to ‘revolution’ form, the road to electronic acceptance has been turbulent yet proactive to course-correct. Most recently, software developers are moving away from prioritizing vendor and sponsor needs and are instead focusing on the requirements of sites and patients during the platform design process. This user-centric shift combined with an appropriate level of data visibility offered to sponsors is building momentum and ultimately increasing the adoption of multi-user technology in clinical trials.
The uptick in digitization begets answers to the most common questions that sites and sponsors have about the use and implementation of trial technology as well as the outcomes it pledges to garner.
How will technology improve my clinical trials and overall data quality?
Among the most glaringly evident issues in clinical trials today is the accessibility of data. With new regulations emerging on increased clinical trial oversight, it’s becoming critical that sites have access to data on the patient-level. To achieve this, digitization is at the forefront with a focus on patient engagement.
Good technology can help improve trial results. In data presented last year, the rate of clinical scoring errors in studies using eCOA was significantly lower than studies that used paper. The built-in logic of advanced platforms like these provides automated scoring and is designed to monitor data entry, ensuring patients don’t skip questions. Helping mitigate risks, the real-time functionality is what provides immediate access to data that wouldn’t otherwise exist.
How do I determine which technologies are worth my time and investment?
A common and quite understandable concern in today’s rapidly changing healthcare market is determining which technologies are worth the time and investment. It comes down to selecting a technology partner that’s focused on producing only best-in-class solutions. Best-in-class means there’s not one solution carrying the entire platform, but instead a series of data collection functionalities. It’s a thoughtful technology stack that prioritizes data integrity, accessibility and an E2E user experience.
The right technology partner will understand the current and future importance of patient engagement and will direct all of its platform upgrades and advancements toward its improvement. The right technology investment will provide patients with a platform they want to engage with, not be forced to use.
How do providers ensure sites will be effective users of technology?
Software providers have always been challenged with creating technology that’s useful to all stakeholders. Historically, platforms started their requirements gathering with sponsor companies. Shifting the focus to the primary end-users – the sites and the patients – brought instrumental improvements to trial technology. This paradigm is a highly collaborative one that drives developers to incorporate functionalities generally required across every study:
Enhanced Flexibility
Platform flexibility is important to all sites and patients. A flexible platform will have the ability to adapt to varying trial protocols and patient populations.
Patient Perspective
Technology that prioritizes the patient experience is key to increasing engagement and compliance. Depending on the trial requirements, an effective platform must be usable and intuitive.
Bring Your Own Device
BYOD has become an increasingly common component. While cost reduction is important, the greater improvement here is in allowing patients and sites to use their own smartphones and tablets. This allows a patient, for example, to not have to carry two smartphones if they are participating in a clinical trial – one for personal use and another to complete their daily diaries.
Integrated Technology Solutions
A platform that considers the various electronic data gathering components of a trial and provides a complete and interoperable solution rather than pieces of one is the goal.
Increasingly, developers are focusing on the requirements of sites and patients to deliver an effective solution for any type of trial. This collaboration provides technology providers with the opportunity to improve the experience for every stakeholder.
Conclusion
The adoption of new technology in clinical trials is on the rise. As more data becomes available to demonstrate how the effectiveness of these software tools can significantly improve patient compliance, engagement and data quality, the technology will become less of a burden and embraced as an improvement by everyone. Moreover, as collaboration between developers, sites and patients increases, these platforms will formalize and become evergreen – making the case once and for all that the adoption of technology in clinical trials is transformative, offering the ability to deliver real ROI.
References:
- Industry Standard Research. (2015). EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015).
Jennifer Peters is Bracket’s Senior Vice President and General Manager for the Scientific Services division. In this role, Ms. Peters is responsible for Bracket's work in Rater Training, Quality Assurance, and Electronic Clinical Outcomes Assessments (eCOA.)
With more than 14 years of life sciences industry experience, Ms. Peters most recently served as a Founder and Chief Experience Officer of Greenphire, a global provider of disruptive clinical trials payment and process optimization technology products serving pharmaceutical sponsors, biotech companies and CROs. She led Greenphire from an idea-stage startup, with three founding employees at its inception in October 2007 to a global technology enterprise with more than 100 employees and 500+ clients when it was sold to a private equity firm in 2014.
Prior to her tenure at Greenphire, Ms. Peters held a series of progressively senior leadership positions beginning in 2002 at Transperfect Translations, a global provider of translation services and localization technology to clinical trial sponsors and CROs.
Ms. Peters holds a Master's of Science degree from Pace University and will be based in Bracket's Wayne, PA headquarters.