Today, life science companies and research organizations face unique challenges related to clinical trial patient recruitment which often causes major delays and challenges for research across multiple disease states. Up to 90% of studies in the U.S. experience significant delays in recruitment and enrollment. Further, nearly one-third of trials under-enroll, and only seven percent meet their target enrollment number on deadline.
Results of a retrospective study of 371 patients with metastatic NSCLC, presented at the 2019 ASCO Quality Care Symposium, showed a gap in beliefs between providers and patients where providers often misunderstood the reasons patients declined to participate.
The findings of the study revealed that, ultimately, participation in a clinical trial correlated with longer overall survival among patients—a median of 838 days of overall survival among clinical trial enrollees compared with 454 days for patients who did not enroll in a trial.
By making the patient the point of focus within a clinical trial, it is possible to improve the retention of participants and their overall experience, while also encouraging non-enrollees to enroll and participate. One way to help make clinical trials patient-centered is by using a unified approach to clinical trial technology, one that encourages a patient-first attitude.
Unified platform empowers patient-centric trials
The tools provided through a unified platform can relieve patient burdens and make it easier for patients to receive care. Let’s explore three specific capabilities enabled by the use of a unified platform that makes it possible to improve patient experience.
Alleviate burden and risk associated with the informed consent process
Informed consent discloses important clinical trial information in a (hopefully) clear and easy-to-understand manner, and then collects the patient’s voluntary agreement to participate. With the increase in clinical trials and increase in trial complexity, paper-based informed consent no longer cuts it, and in fact, contributes to increased drop-out rates and increased inspection findings.
Electronic informed consent technology, such as Medidata Rave eConsent, provides patients with a guided learning experience to gain a better understanding of the study’s purpose, risks, benefits, schedules, and their rights and responsibilities.
Promote remote participation through virtualization of clinical trials
While traditional clinical trials often require patients to drive or fly to a clinical site, virtual trials allow patients to work with clinicians from the comfort of their own homes. Remote participation opens the field to new participants and eliminates the need for expensive, time-consuming travel.
With the right platform, participants can opt in to remote contact and generate substantial data. Remote data collection lets patients record their data on the spot, cutting costs and eliminating errors. Such a platform enables sponsors to strike the right balance between site-based and virtual visits to deliver a true patient-centric clinical trial with more engaging and dynamic patient participation.
Boost patient engagement and wellness with less intrusive data collection
With people connected 24x7 via smartphones, the move to electronic clinical outcome assessments that deliver fully validated instruments to the patient on their smart devices is in full swing. This improves patient experience during the trial by providing them with the ability to input their data in a user friendly, compliant manner through the use of familiar technology. Further, mobile data collection through smartphones provide research organizations with a new stream of data that can help address questions that couldn’t be within traditional trials.
Memorial Sloan Kettering Cancer Center conducted research of newly diagnosed multiple myeloma patients whose physical activity and sleep were bio-monitored using Medidata Rave Wearable Sensors along with Medidata ePRO. Sloan Kettering concluded that electronic mobile device monitoring may be a useful tool to assess patient’s overall health and wellness and especially useful for tracking elderly and unfit patients. This not only enhances data integrity but also the accuracy of data collected during the study. It is a win-win for patients and clinical trial professionals alike.
The patient journey extends before and after a clinical trial, starting with education about the study and moving through the informed consent process, data capture, analysis, and study closeout. It’s important to understand how patients want to interact with a clinical trial while also considering that accessibility, site convenience, support, and engagement can lead to improved patient satisfaction. With this trusted platform approach to clinical trials, you are empowering patients and making them an active stakeholder in clinical research.