As we discussed last week, over the next few weeks we’ll be looking at how Patient Engagement can effect clinical trials.  In order to move on to architecture (next week – February 4th) and the business value (February 11th), we need to discuss the required features.

There are core features (architectural components?) of Patient Engagement in Clinical Trials:

  • Investigator Portals
  • Patient Portals

Ok, so one could argue that both of those are architectural components.  But if we detail out the features of each, they simply become containers by which we can understand the full feature set.  Let’s look at them individually.

 

Investigator Portals

These have been around for quite awhile – so we’ll deal with them briefly.  Many consider an Investigator Portal to be merely a component of CTMS (clinical trial management system).  There are others who feel that they can be (and are) stand-alone applications.  When thinking about this use for Patient Engagement there are some additional features in an investigator portal that need to be supported. 

Patient Portals

These are relatively new in the clinical trials realm.  They have a broad range of features, primarily focused on keeping patients engaged with the study, but also driving down the cost of clinical trials by capturing more data directly from the patient (through Connected Devices) which lowers the number of visits are required to the investigational site.

 

Below is a table of just some of the features:

Investigator Portal Features:

  • Give investigators & sites access to most recent documents (like Informed Consent Forms, Investigator Brochures, etc.)
  • Enable 21 CFR Part 11 compliant security for documents, workflow, etc.
  • Real-time and near-real-time collaboration between the investigational site, including study personnel, CROs (contract research organizations) and the study sponsor (the pharmaceutical, biotechnology or medical device company)
  • Provide investigators with access to dashboards that detail progress on patient enrollment, which requires access to the study specific EDC (electronic data capture) data
  • Collaboration with the sponsor on eTMF (electronic master file) documents
  • Securely receive messages from sponsors
  • Detail and manage tasks for site study personnel
  • Access to individual patient data, both from the EDC application (which would in the best scenario also integrate with the EMR) as well as from the patient portal and the patient’s connected devices.
  • (Not really an investigation portal feature, but a necessary action) Give patients a “clinical trial in a box” which would provide the necessary connected medical devices for the trial as well as login information into the patient portal.

Clinical Trial Patient Portal Features

  • Provide patients access to their own health data
  • Capture patient ePRO (electronic patient reported outcomes, eDiaries, etc) in the Investigator Portal, Patient Portal and EDC
  • Provide primary care physicians with secure access to study specific patient data – to coordinate care with study investigator.
  • Real time collaboration capabilities with the study site, including study visit information
  • Provide patients with medication and other study reminders through their preferred medium: browser interface, smartphone app, cell phone txt (SMS) messages or IVR (interactive voice response).
  • Provide integration with ePRO and eDiary applications through the patients preferred medium: browser interface, smartphone app or IVR
  • Make capturing patient data easier by utilizing “Connected Devices”, medical devices that capture data directly from the patient, distributing the information to the patient, the primary care physician, the investigational site and the EDC application.
  • etc

Again, these are just some of the features and requirements for patient engagement in clinical trials.  If you think I’m missing some, please feel free to send me an e-mail at ljordan@microsoft.com

 

Until next week!