Collecting data electronically can deliver huge benefits to patients, pharmaceutical companies and CROs conducting clinical trials. However, when it comes to using electronic clinical outcome assessments (eCOA) – especially electronic patient reported outcomes (ePRO) ─ in a study, few people can claim to be experts.
Here we break down the process into just 10 steps to give you confidence in implementing Electronic Data Capture in your next trial.
Step 1: Identify who’s Responsible
If you’re a larger sponsor or CRO, consider setting up an internal eCOA team that includes people with direct eCOA experience and therapeutic expertise. But, if you’re a smaller organization without the resources to maintain an internal eCOA team, select an eCOA provider you can rely on to advise and support you throughout implementation and the trial lifecycle.
Step 2: Plan for Internal Process Modifications
When developing your initial project plan, take into consideration any internal process modifications required for eCOA data collection, including modifications related to protocol specifications, data collection, management, analysis and reporting.
Step 3: Define your eCOA Strategy and Select the Best Devices
Your eCOA provider will be able to support you in defining your eCOA strategy, including which devices are most suitable for your particular study. Some of the factors that should be considered are patient population characteristics, data collection processes (for example, the number of questions expected, frequency and type of data to be collected, etc.) and regulatory compliance.
Step 4: Ensure eCOA Devices are Adequate and Licensed
According to the FDA PRO Guidance, each instrument used in a clinical trial must be ‘fit for context of use,’ licensed by the copyright owner, validated for electronic implementation and be translated/localized. These steps may be handled by the trial sponsor, eCOA provider, CRO or translation provider.
Step 5: Determine Modality Strategy
Work with your internal eCOA team or eCOA provider to select the most appropriate modality for your study (See figure). It is important to ensure the modality you choose is regulatory compliant – especially if you are using more than one eCOA modality, as mixing modalities carries additional data integration and regulatory risk.
Step 6: Select Your Procurement Method and Create a Data Transmission Agreement
Will your study work best by provisioning all devices or is a mixture of provisioned and Bring-Your-Own-Device (BYOD) more appropriate? Your eCOA provider should be able to provide both services and to advise on which is best for your study.
Also, since data transmissions vary widely depending on location, it’s best to provide each eCOA device with multiple transmission method options, both digital and analog. And a data transmission agreement should be drawn up that defines the structure of the data transfer.
Step 7: Customize Reports to Get Actionable Intelligence
If working with an eCOA provider, you should expect to receive customizable monitoring reports that enable sites and study teams to access real-time data online. These reports will provide actionable intelligence across your studies, sites and patients. Ask your provider if the reports include filtered insights, an intuitive visual interface, automated triggers, and at-a-glance views of issues and trends.
Step 8: Develop a Device Shipment and Deployment Plan
The success of any clinical trial is largely determined by the investigative sites that enroll patients, so have adequate eCOA devices when and where they are most needed. Your eCOA provider should be a valuable asset in developing a device shipment and deployment plan – including custom requirements and other regional regulations to address problematic countries – to ensure your investigative sites receive their devices on time.
Step 9: Develop a Training Plan and Training Materials
eCOA providers are typically responsible for providing a plan and related documentation for training clinicians, site staff, patients, observers and caregivers. Make sure your study’s training plan includes an eCOA device training kit – with detailed instructions for training patients ─ as well as site support guides to ensure eCOA study success.
Step 10: Develop and Conduct Site Testing
Finally, site testing verifies that the eCOA system and devices comply with your study’s Requirements Document. Your eCOA provider can offer instructions on how to conduct testing. Those who wrote the protocol and provided study requirements should contribute to verifying that these requirements are satisfactorily met.
Implementing eCOA in clinical trials may require more initial work up-front, but in the end, proper planning will save time, money and frustration. By planning early, working with an experienced eCOA provider and providing ongoing training and communication throughout the process, sponsors and CROs of all sizes can easily implement eCOA in their trials and benefit from higher quality data, better patient compliance and engagement, and shorter timelines.
Dee Zepf is a Sr. Director of Global eCOA Product Management at ERT.