Mike Nolte,CEO ,CRF Bracket
NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
Most businesses and individuals involved in clinical research would argue that an industry priority should be improving the patient experience. The reality, though, is often quite different. Patient focus potentially simplifies the research conducted today and accelerates potential future benefits of wearable devices, mobile apps and other services and technologies. Extending the simplicity and reach of the patient’s experience makes participating in a clinical trial more accessible and more convenient, while delivering more reliable data, lower costs, and better-quality trials.
What are the barriers to reaching this goal? While the underlying technologies are well understood and often commonly used in other industry settings, adoption in research tends to move slowly. Typically risk-averse, clinical research buyers see new solutions and workflows as variability that, if not managed well, introduces risk into sizeable drug development bets. Barriers to digital advancement also include uncertainty over regulators’ expectations and requirements, and data safety/privacy concerns.
Envisioning the Perfect Trial
Simpler patient interactions reduce patient burden, reduce stress and make trials easier to join in the first place. That simplicity also creates value for sponsors and CROs through lower drop out rates, improved compliance, shorter cycle times, and more reliable data. So how can this simplicity be achieved? If we envision the “perfect” trial, it would start with a target number of participants. What if technology allowed us to recruit that number of patients immediately, get them enrolled, get them through inclusion/exclusion criteria, consented, randomized and into the trial? What if then, those same participants were highly engaged, stayed in the trial for the right duration, helped support quality data, took their medication as intended, and then ultimately completed the trial successfully? While clinical research isn’t about perfection, software solutions, built with this end in mind, can have enormous impact.
The reality today is that patients in studies receive a mixed experience of technology, often exacerbated by many systems. For one, they might experience as many as three or four different devices (wearables, measurement devices such as a glucometer, reminder applications, electronic informed consent, payment applications, and e-Diary/ePRO solutions are all possible). Sites conducting research face similar complexity as well. This all results from a fragmented approach and inconsistent adoption where the patient’s experience is far from the organizing principle.
Seeing technology as a cohesive, organized network in support of the common interests of patients, sites, and biopharma sponsors is counterintuitive to the latest trends, whether that’s virtual/hybrid trials, artificial intelligence, big data, or advanced mobile platforms. The critical questions all relate to ways that technology can simplify research through better serving its most critical participant rather than pursuing the latest trend. Process based, holistic thinking, not innovation for its own sake, has the most potential.
Successful strategies might be founded on three elements:
Seamless integration and collaboration of software, devices and service providers with the trial journey as a single-minded organizing principle.
Technologies that fit seamlessly in both the conduct of research and the daily lives of patients with engagement at all points along the trial journey.
Emphasis on communication and data collection with simple, integrated device integration and high-quality imagery and video communication tools.
A patient-centric approach clearly improves data capture, patient retention, and protocol compliance. The future suggests patient solutions performing as an integrated network have the most potential to deliver on that approach. This includes software like electronic clinical outcome assessment (eCOA), eConsent, patient engagement, analytics and various devices. Simplicity for the patient also delivers speed and reliability for study teams with access to real-time study insight, improved oversight, efficient trial operations and higher quality data. All stakeholders benefit from rethinking the role of technology in supporting patients and supporting efficient, cost-effective, high-quality research.(PV)
CRF Bracket was formed in 2018 by the merger of CRF Health and Bracket to provide life science companies with patient-centric technology solutions that advance clinical research and transform the patient experience. The company’s solutions include electronic clinical outcome assessment (eCOA), eConsent, patient engagement, interactive response technology (IRT), clinical supply forecasting and management, and endpoint quality services that combine advanced analytics and therapeutic area-specific scientific consulting. CRF Bracket’s applications are trusted by pharmaceutical companies of all sizes, including all of the top 20 pharmas, as well as CROs, biotechs, and academic institutions on over 4,000 global clinical trials. For nearly 20 years, CRF Bracket has been committed to helping life science companies bring life-changing therapies to patients and communities around the world.
For more information, visit http://www.crfhealth.com and www.bracketglobal.com.