Three Tips for Successful eCOA in Global, Decentralized Oncology Trials
The idea behind implementing decentralized clinical trial (DCT) approaches in oncology trials is to improve the participant experience. While participants may still need to visit clinics to receive infusion medications in most oncology studies, DCT elements can ease their trial burden by collecting data remotely in between visits. A key component of this strategy is the effective use of electronic clinical outcome assessments (eCOA).
Following are three tips based on THREAD’s experience helping sponsors to manage successful eCOA programs in oncology studies.
#1. Employ Easy-to-Use Technologies
Participation in oncology studies is often exhausting. For participants, their loved ones and caregivers, juggling study requirements along with their everyday life responsibilities require tools that make submitting data as simple as possible. Think about it: if you are home and feeling tired and ill from the effects of your latest dose of chemotherapy how likely are you to tackle a multi-step, confusing data entry process?
DCT eCOA strategies should incorporate smart device or web-based applications designed with simplicity in mind. The process should be seamless and obvious and should allow the participant to get through their task quickly, so they can get back to focusing on those things most important to them – their loved ones and the interests that bring them joy and help them to relax.
#2. Bake In the User Support Features
Even with the most intuitive applications, there are bound to be questions. Make sure your participants have easy access to support, preferably within the very same applications they use to submit their eCOA data. Many user questions can be addressed through built-in libraries of support content like videos, infographics, and FAQ sections. For more specific or unique questions, the ability to contact the study team easily within the same application is ideal, and lets participants know they are supported at all times, no matter what.
#3. Make Sure Support is Localized
A common mistake in some global studies is the tendency to employ one-size-fits-all approaches to save money. However, when it comes to translation and localization for participant support, failing to adequately address the language and dialect usage of your global audience will cause frustration with participants and can lead to noncompliance. In tip #1 we spelled out the importance of making DCT technology easy for oncology study participants to use and in tip #2 we talked about making support easy to access. All this work will be undone if the participant in need of help can’t consume support material nor communicate effectively with a support team member. Seek out solutions and vendors with access to global partners to provide a network of localized support. For example, the ability to schedule an on-demand video visit allows patients to bring up their questions or fears in real-time - in the correct language and dialect – with a local member of the study team. For a stressed out, tired oncology patient, the ability to speak with or otherwise interact with an informed study team member in their own dialect can be the difference maker in terms of whether they are able to reliably submit their data.
While data collection in global oncology DCTs presents its share of challenges, following these three tips can help set a foundation for success. At the heart of any effective eCOA strategy for oncology, is a patient-first approach that considers what cancer patients go through and how to make clinical trial participation, including eCOA data submission, as simple and stress-free as possible. Giving oncology study participants intuitive tools, with ample support that is tailored to how they communicate are great steps toward the effective collection of eCOA data in global oncology DCTs.
For more information on how THREAD can help you build effective global DCT programs, visit threadresearch.com.
Chris Watsonis the Director of Consulting for THREAD
Chris is an experienced Product leader and clinical system specialist with over 21 years’ experience of product management. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, a thought leader in eCOA solutions and patient-facing technologies, Chris is helping shape the direction and application of global eClinical solutions