Align Your Clinical Trial Imaging Strategy with Patient Expectations | 5 Ways CROs Can Future Proof Their Medical Imaging Strategy Series

This is the third blog in the 5 Ways CROs Can Future Proof Their Medical Imaging Strategy series. 

This blog was authored by Andrea Falkoff, Senior Director, Product Management, Rave Imaging at Medidata. Andrea is responsible for the Medidata Rave Imaging product strategy and also works directly with customers and internal stakeholders to ensure best practices are applied across imaging in clinical trials.

Evolve Patient Expectations for Clinical Trials

Patient expectations when participating in a clinical trial have changed immensely over the last decade. This is due to the fact that patients are now more knowledgeable about their diseases, more engaged, and more tech savvy. And especially following the pandemic, patients expect reduced burden through the use of digital and remote clinical trial technology (similarly to almost all other areas of their lives) and reduced timelines. In Medidata’s recent industry research report, senior executives in the sector were asked what they thought patients would begin to expect from clinical trials. Nearly half (48%) cited increased use of remote tools and solutions, including patient monitoring, ability to receive study medication at home, and remote data collection—all of which go hand-in-hand with a decentralized clinical trial design.

Against this backdrop of patient expectations—alongside an industry that is pushing for more decentralized approaches to clinical trials—there’s been much evolution and progress in the tools and solutions that make decentralized clinical trials (DCTs) possible. Electronic clinical outcome assessments (eCOA), or electronic patient diaries, have been around for a long time; but not only has the tool's uptake increased over the past few years, but so has its evolution and functionality. eCOA supports a patient-centric approach to clinical trials and provides patients with an easy method to input their data, reducing the need to travel to a trial site and helping to improve their lifestyle. 

Add a Medical Imaging Capture Capability

The use of eCOA across clinical trials is already prominent—having only been augmented during the pandemic. It can be hugely beneficial to increase eCOA functionality to include imaging. Patients who are already inputting their data into eCOA, might as well be uploading their images in the same tool and with the same device. This would truly support a patient-centric DCT approach. And getting all this data in real time can help drive faster clinical trial timelines.

Apply Across Therapeutic Areas

Clinical trial tools that enable remote image capture can be used on a growing number of indications, such as dermatology, infectious disease, musculoskeletal and inflammatory disease, and ophthalmology. It can even be applied to oncology trials to capture skin lesions and any dermatological reactions or changes (which is especially relevant in skin cancers). Today’s mobile technologies readily equip patients to directly capture images to document symptoms and milestones, treatment regimen compliance, confirmation of appropriate placement of wearable devices, test readings, and more.

Benefits Spanning Across All Stakeholder Groups

Adding medical imaging capture capabilities within an eCOA tool lets stakeholders realize multiple benefits, leading to better experiences and more efficient processes for patients, sponsors, CROs, and sites.

Patients

Imaging capture reduces the burden on patients so they can experience enhanced engagement. It lets patients and caregivers securely share images from any location using their own devices. Patients easily share photos of symptoms, trial assessments, and experiences with their study site. Additionally, patients easily access their trial activities from one location and virtually engage with their study staff, creating an increased touchpoint of engagement outside of the clinic. 

Sponsors and CROs

Image capture capabilities provide more comprehensive insights into the patient’s clinical trial journey by collecting more data outside of the trial site (compared to one-time visits). The images become a part of the patient record on a unified, secure platform and gives real-time visibility to help research teams make real-time decisions. It also lets sponsors and CROs enroll a larger population and select who they want to be a part of the study, allowing for more diverse patient groups. Clinical trial patient recruitment is also enhanced by having patients submit images of assessments to qualify for a trial (for example, if an EKG test were needed, a prospective patient could easily upload the image for review). Finally, it frees up resources so study teams can focus on other things.

Trial Sites

Sites can use image capabilities to gain a better understanding of a patient’s illness and to conduct remote assessments of patient symptoms. Site burden is also reduced because staff is freed up to attend to other responsibilities and can optimize when in-person visits are necessary through remote review.

Drive Patient Centricity through Medidata’s Enhanced eCOA Tool

Managing this additional clinical trial data can be complex, leading to major quality challenges and trial delays if not performed properly; this is particularly detrimental in early-stage trials. Medidata is one of the few providers that have an image capture capability within its proven eCOA tool, alongside extensive imaging expertise.

As part of Medidata’s unified platform, eCOA image capture lets sponsors, CROs, and sites collect images directly from patients and caregivers across a wide range of therapeutic areas using their own, or provisioned, devices. Additionally, capturing EXIF data (or exchangeable image file, a format that is a standard for storing interchange information in digital photography image files using JPEG) lets you pull relevant information about the images; this makes sure that the same device is being used by the patient throughout the duration of the study, for example. 

After an image is captured on a patient's device, it is securely submitted through Medidata eCOA and then flows seamlessly to Medidata Rave Imaging for secure storage, de-identification, and routing to the right person—creating a streamlined experience for all stakeholders. Since eCOA image capture is connected directly to Rave Imaging, sponsors, CROs, and sites benefit from having all data in one location directly within Medidata Rave EDC. This connectivity allows for secure and compliant collection and storage of images, while intelligent workflows make sure that images are routed to the correct person for remote review and assessment in near real-time to reduce the chance of error. Additionally, Medidata’s dedicated Patient Cloud Helpdesk is focused on end-to-end experience and delivers comprehensive support for sites, sponsors, CROs, and patients.

By aligning with patient expectations and their desire for more decentralized approaches, CROs can leverage eCOA imaging capture capabilities to add another layer of convenience for patients and, in turn, help future-proof their imaging strategies.

Look out for the next blog in this series coming soon. Read the first blog here and the second blog here. 

Contact our imaging and EDC experts to find out how Rave Imaging transforms image management in clinical trials.