When conducting a decentralized clinical trial (DCT), several considerations need to be taken to achieve the balance of being patient-centric while also ensuring that the necessary scientific data is captured to test against trial endpoints. To do this effectively, one of the components leveraged to capture the requisite scientific data is connected health devices. These are devices that patients may use to participate in clinical trials in a remote setting for more data to be captured outside of a clinical visit while enabling sponsors to capture more data outside of a site-based visit.

When adding connected health devices to the conduct of clinical trials, the first step is to explore how their incorporation can fit into the current business strategy of clinical trial conduct. If there is no strategy, this will be required to ensure that companies get the value that they expect out of the use of connected health devices to capture additional data that will be generated.

Without a strategy to use connected health devices, there are challenges through the conduct of the study — ranging from delays in protocol definition due to protocol amendments on the front end to the use of the increased data generated by the devices on the back end. To effectively implement connected health devices into the clinical trial conduct, companies need to spend the appropriate amount of time on the frontend processes to simplify the backend processes once the data has been collected. As there is a monetary impact, any delay has the potential to significantly affect the amount of revenue that companies achieve through the introduction of new therapies to the market. This is why companies must spend the time to chart a path for the use of connected health devices in clinical trials.

When establishing a strategy to use connected health devices to their full potential, companies must consider:

• Protocol endpoint selection
• Device types to provide necessary data
• Processes to incorporate connected health devices into protocol during the protocol drafting process
• Technical integration of devices into CDMS applications or clinical repository
• Processes to effectively leverage increased data that comes from the use of connected health devices

By working with numerous companies to implement DCT while leveraging connected devices, clients have not seen the benefits they would expect to achieve through their use. The reasons differ as to why the value of connectedness has not been realized, but in each situation, when a strategy has been established, these companies did begin to see the benefits of their use.

Once the strategy is established and there is alignment within the business as to how devices are intended to be used, how additional data will be generated and appropriate processes that are impacted by implementing connected health devices, the real work begins. It is now time to implement the strategy and conduct patient-centric clinical trials.

Typically, the complexity of integrating into clinical applications is the need to execute a total GxP effort for every integration into those systems. As such, a path for companies to leverage when implementing their strategy is the creation of a library of devices for use. This enables easier implementation of connected health devices, as the library is integrated with clinical applications. Companies only need to perform this total GxP effort for each type of device integrated into the clinical applications. This is not the only GxP effort required to add new devices to the ecosystem, but the effort is significantly simplified. Once the integration of the library with the clinical applications has been completed, the only effort required going forward is to integrate new devices into the library and ensure data that comes in from the device aligns with the requisite dataflows created on the backend.

Once the connected health device library has been created, clinical trials using devices from the library can be more easily implemented due to the devices already being integrated into the clinical trial ecosystem. Simplifying connected health devices through clinical trials enables companies to benefit from shortening the timeline to implement them. Patients also benefit through this patient-centric approach in which they can participate in the clinical trial remotely using these connected health devices.

After this library has been created and integrated into a client's clinical trial dataflows, pushing this out to partners and vendors (i.e., CROs, DCT vendors and other sponsors) is straightforward. It enables the client to have control of the connected health devices used for clinical trials throughout the ecosystem.

Connected health devices and the creation of libraries for the use of these devices during clinical trials will continue to deliver value to both sponsors and patients. Advancements will be made to have additional device types available in a remote setting, enabling greater remote patient participation in clinical trials. Significant advancements in the use of connected health devices in clinical trials have been made in this post-COVID era, and the future looks bright for expanding their use during clinical trials.