StudyPal - Clinical Trial Mobile Platform

An echo system for Sponsors to push study material to Investigators and provide direct to Patient remote clinical trial

Increasing Clinical Trial Engagement and Collaboration

Developing Novel Endpoints Generated by Mobile Technology

Mobile Apps for Novel Endpoints

By Wessam Sonbol On June 26, 2018

"Mobile technology can be used in clinical trials to generate novel endpoints that provide new kinds of information that were previously difficult or impossible to access. " CTTI

Clinical Trials are complex and have so many moving parts, with patients on one end and data quality on the other (emphasis on the patients because if we do not have patients, we will not have the data to collect). However, we fail to focus on the user experience and in this case - it would be patient experience. Nearly 85% of Americans have smart phones and over 36%(~2.7 billion) of the world's population are estimated to be using smart phones by now.

Given that patients are at the heart of EVERY clinical trial, below are some of the biggest issues we often heard about "Why Patients Dropout" and "what can we do to keep the patients engaged?";

  • Inconveniences to the patient
  • Forgotten Appointment
  • Lack of Engagement

We also connected with 6 clinical trial managers (CTM) and asked what collaboration tools they currently have in place. It was surprising to hear that 4 out of 6 are still using email and paper trail. Then we asked the CTMs, "how do you provide patients with the study material (i.e. Inclusion/Exclusion)".

Applying Mobile Technology To Capture Endpoints

Below are some ideas on how to implement mobile apps for your study, based on CTTI's recommendation

  • Use text messages and a mobile app to capture a patient condition from the comfort of their home
  • Engage the patient periodically through SMS to capture diary information and assess current condition
  • Create a flowchart for Investigators to showcase endpoint and study approach
  • Keep protocols up to date through an app - to ensure up to date compliance
  • Enable site staff to capture source material and upload directly to patient file through a mobile app

What do patients get?

Patient Diary in Clinical Trial Patient Diary in Clinical Trial
  • Flexibility to answer their diary questionnaires from the comfort of their home
  • Automated alarm to confirm their upcoming appointment
  • Stay in the know and to stay engaged in the study

Mobile Technology in Research

Applying mobile applications in clinical research can add a lot of value to sponsors, investigators and patients, enabling faster, more cost-effective trials.

Through the application of mobile technology and cloud solutions, clinical trials would provide more patient centric capabilities, allowing them to remotely receive study educaiton material, document diaries, receive notifications for their visit schedule, get reminders for their medications and decrease follow-up failure rate, all available as a mobile app on a users phone/tablet.

Through apps such as StudyPal, protocol information is simply configured through a web interface, making it also available through the app. It is a mobile app, with role based security allowing sponsors, investigators and patients to all gain access to the information they need. For example, investigators can quickly Randomize a patient and share study education information from the app, allowing the patient to also download the app to review education material and respond to questionnaires/diaries from the comfort of their home. Given that the solution is role based, a medical monitor can also receive notifications for any SAEs that occured.

Clinical Trial Investigator & Site Recruitment

  • Study Design
  • Inclusion/Exclusion
  • Treatment of Subjects
  • Study Visits
  • Forms to be completed for each visit
  • Assessment of Safety
  • Adverse Events
  • Study Contact(s)
  • Randomization
  • eDiary
  • Messaging
  • Protocol Amendments
Investigator Engagement

In a study that was published by Tufts, it is mentioned that an increased emphasis on both patient reported outcomes and digital technology in clinical trials has enhanced industry focus on electronic patient reported outcomes (ePRO). The study also provides further details to cost savings and the expectation for such mobile technologies to increase.

Protocol Amendments

This mobile app can also capture protocol amendments, allowing different sites to be on up to date on their latest approved protocol version.

Our cell phones can help us be more efficient and reduce cost

  • Accessibility. Rather than having to read through papers and browse through emails, have it available at your fingertips, anywhere.
  • Boost product branding.
  • Study tips and training material available on the go.
  • Consistency to ensure everyone has the latest protocol information.
  • Improved communication through alerts and updates to the study team and track receipts.

StudyPal mobile application was designed to digitally increase clinical trial collaboration and engagement among Sponsors, Investigators & Patients. A mobile app providing eDiary, eRandomization and eProtocol, designed to increase study conduct & boost physician and patient engagement! Learn more here.

Our aim is to accelerate drug development and save more lives.