Keeping patients enrolled and active in clinical research is one of the biggest obstacles to study success. But increased protocol complexity and rising costs make it hard to balance patient engagement efforts without stifling the development of new drugs and therapies.
The emergence and adoption of innovative clinical trial technologies are helping researchers maximize efficiencies to strengthen engagement efforts with patients. Let’s explore how novel technologies are reducing complexities in trials and supporting stronger, more intentional engagement that results in stronger patient outcomes.
PRO surveys are essential for showing patients that their experience matters and that researchers are listening. With the advent of ePRO, this process has undergone a crucial technological upgrade: patients can take PRO surveys electronically, either in the clinic or at home. Evidence suggests the patients like it this way: In a survey of 158 cancer patients, 65% preferred electronic PRO surveys to paper-based ones.1
ePRO is a leading patient-centric technology because it empowers patients to enter data from anywhere in the world and at any time. Flexible schedules and pre-set reminders improve patient compliance and closeout windows help support time-sensitive data collection.
As COVID-19 threatened to close or slow a majority of clinical trials, a record number of studies adopted ePRO technologies. Sally Urwin, Clinical Data Manager at Hollister Incorporated weighed in, “We would be in a very different situation if we did not have ePRO capabilities. We have not experienced any delays in our studies and we’re hearing from some patients that they are even more willing to participate now because ePRO allows them to submit their responses remotely while they are at home more during this time. ePRO is truly what keeps our research going.”2
Confusion around processes, protocols, and expectations continues to be a leading reason why patients drop out of studies. Digitally-enriched consent forms may be the key to unlocking true informed consent.
IC forms often contain complex scientific language that laypeople can struggle to understand – especially as most are written at a higher-than-recommended reading level. Modern web-based applications for eConsent can be embedded with videos, gamification, and or other digital media to enhance patient comprehension—especially for those with lower health literacy.
Research has shown that video can bring patient comprehension of IC material all the way up to 95%.3 As clinicians continue to improve patient’s understanding and satisfaction with eConsent, experts say it will be useful in enabling the development of customized IC.1 These personalized IC workflows could be tailored to an individual’s socio-cultural characteristics and help achieve more consistent patient adherence.
Patients want to be considered partners in the trial process, but many feel removed from the current state of clinical research. Patient portals are helping participants access information about their trial, complete online eConsent and eCOA forms, and do it all through a single touchpoint. Patient portals increase patient adherence and engagement during the trial and can reduce the substantial costs associated with high drop-out rates.
Web-based patient portals invite patients to view study progress, receive dosing reminders, complete pre-screening forms, and access training all from a secure interface. Studies benefit from being able to support multiple devices per patient, as well as patient-preferred devices. Patients benefit from a device-agnostic web-based solution that simplifies access to critical study information and provides real-time, validated data to their study teams.
As clinical trials continue to grow in complexity, it can have devastating consequences to patient engagement as well as trial timelines and budgets. The average trial is collecting data on 86% more endpoints than the last decade. These growing endpoints result in complex protocols that simultaneously threaten patient adherence and increase the likelihood of mid-study amendments.
In fact, a new study by the Tufts Center for the Study of Drug Development (CSDD) found that the average trial experienced 4.1 planned and 3.7 unplanned mid-study changes. And each mid-study change added an average of 30 days to the trial timelines.
Although completely avoiding mid-study changes may not be realistic, technology is helping to minimize delays with eClinical efficiency. Integrated eClinical solutions are necessary to synchronize data across dispersed systems and minimize the impact of mid-study protocol adjustments. Working with a responsive, adaptive eSuite empowers clinical teams to create patient-centric workflows and streamline study management for a proactive response.
Control study modifications using dedicated testing environments. Make mid-study changes in a matter of minutes without impacting users who are working in the live instance. With an intuitive, integrated interface, your teams have complete visibility and control to make mid-study changes that minimize the impact on patients and trial timelines. By facilitating smooth mid-study changes, your team can accelerate their go-lives and bring new treatments to market faster.
Patient-centric technology is helping to bridge the gap between clinical research and the patient perspective. Clinical teams need to keep abreast of emerging technologies that remove barriers for patients and provide meaningful outcomes. At Medrio, our solutions were designed to both empower patients and inform clinical research teams. We do this through our unified eSuite of EDC, eConsent, ePRO, eCOA, Direct Capture, and RTSM along with external CTSM, imaging, and telehealth integrations.
Enhance your patient engagement and accelerate your timelines with patient-centric solutions that ensure you never miss a data point and your patients never miss a visit.
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1 Wintner, L.M., Giesinger, J.M., Zabernigg, A. et al. Evaluation of electronic patient-reported outcome assessment with cancer patients in the hospital and at home. BMC Med Inform Decis Mak 15, 110 (2015). https://doi.org/10.1186/s12911-015-0230-y
3 Foe, G., & Larson, E. L. (2016). Reading Level and Comprehension of Research Consent Forms: An Integrative Review. Journal of Empirical Research on Human Research Ethics, 11(1), 31–46. https://doi.org/10.1177/1556264616637483