Using patient medical records including assessments, tests, procedures and other relevant medical history for Clinical Trials has been a common-place practice supported by very robust and comprehensive platform systems. With the pervasiveness of mobile devices, healthcare wearable’s and other sensors, there is a tremendous opportunity to collect rich and more complete dataset directly from patients. Medidata Patient Cloud is a comprehensive and regulatory compliant mobile health (mHealth) solution that significantly enhances ability for patient data capture to propel sponsor’s mHealth studies.
At the Medidata annual Symposium this week, BTC was on the panel to discuss client uses-cases and using AppConnect to develop custom mobile applications that can be used to collect patient reported outcomes data, improve patient engagement and continued participation in the clinical trials. Below are a few questions posed to the Panel of AppConnect Partners, with summary responses from Boston Technology Corp.
1. Starting with the basics – why mobile in clinical trials? Why now?
The biggest reason is the participant. They are so used to using mobile apps in all other aspects of their lives that not having an app to participate in a trial would seem odd.
Features that a mobile clinical trial app can provide:
- Reduced data entry time
- Reduced data entry time
- Error checking and validation at every step of the process
- Pre-filled fields, pickers, codes etc. to reduce data entry tasks – eg. when filling out the type of medication, the app user can pick it from a pre-defined list
- Workflow to help site personnel with relevant information – for example if the user answers “Yes” to “Were Adverse Events Reviewed and Log Updated?”, the app verifies that the AE is in the system and may bring up the details if needed
2. One of the biggest questions we all face around trusting the data – e.g. data quality, data integrity, getting to the right clinical endpoint, etc. How should we as an industry be thinking about these kinds of challenges?
Data Quality can be improved by enforcing rules and logic during data collection. For example having a lower and upper limit for blood pressure readings can ensure that the boundary rules are enforced.
Getting to the right clinical endpoint is a function of the app development and deployment. The endpoint will be configured and tested thoroughly before rollout to ensure that the right data is going to the right place.
3. A critical challenge for mobile in general is engagement. In clinical research this is particularly true. Issues range from IT issues in accessing apps to keeping patients engaged throughout the trial. What best practices are you using to address this?
Error handling mechanisms can be provided to gracefully and accurately handle technical issues. For example, if the user loses network connectivity during the course of providing trial data, then the app can store all the trial data offline and push the data to the server when connectivity is restored – all in an automated fashion with no action by the user.
Once the patient starts participating in the clinical trial, engagement and retention can be improved using the following features:
- Up to date research information provided real time
- Allow app users to set up their area interest and preference criteria
- Notifications on upcoming trials (based on criteria above)
- Provide information on trial site (map, directions) and contact iformation to contact point people for the trial
- Provide helpful information like location of restaurants, lodging and other amenities close to the trial site
4.Are there other best practices you recommend in terms of clinical research apps?
- All the data collected from the subject will be stored on a secure database server
- No subject data will be stored permanently on the device
- To allow for contingencies like loss of signal, loss of internet access etc. some data may be stored temporarily on the device but it will be cleared once it is sent to the server. The data will be encrypted when stored on the device
- All subject data being transmitted to the server will be encrypted in transit
5. As the industry & technology matures, where do you see mobile’s place in clinical research in the future?
Apple’s ResearchKit is mainly targeted towards medical research. But using it in clinical trials is the next logical step. The only barrier now is not technology but a change in thinking in the clinical trial ecosystem. And this change is already underway.
There will be instances when a patient will need to visit a hospital or a study center, and that cannot be replaced by a mobile app, but a bulk of the interaction could happen with the convenience of a mobile app.
In Summary, mobile apps can provide ROI in 3 areas of a clinical trial
1. Increase Recruitment – Targeted messages, following up with potential subjects, providing relevant content to a potential participant – are all possible through a trial based mobile app
2. Effective Engagement – Mobile apps can engage patients by providing them with relevant information, emphasize the relevance of the research, provide helpful resources, provide reminders to track appointments and medications, make the process of data gathering easy (they can provide the data conveniently at any location) etc.
3. Accurate, Valid Data Collection – Validating the data provided, getting data directly from devices and clinical health systems – not only reduce data entry required but also ensure that data integrityBoston Technology Corporation develops custom mobile applications research studies and provides mHealth platform solutions for sponsors, see http://boston-technology.com/case-studies