An echo system for Sponsors to push study material to Investigators and provide direct to Patient remote clinical trial
By Wessam Sonbol On May 26, 2017
Collaboration in clinical trials and ensuring proper patient education about the available treatment options through research remains to be a barrier to increasing patient enrollment and the conduct of a clinical trial.
During MAGI East Coast 2017 conference, we interviewed nearly 35 sites and heard their frustration about the lack of appropriate tools available for better engagement during the course of any clinical trial. Below are some points of frustration that we heard:
The responses we received above were along the path of what we heard previously, but it was interesting to hear the following from site managers involved in clinical research;
Our investigators do not really want to read through an entire protocol that is 20+ pages long. Then when they receive the protocol updates, they have to review more of it.
It takes so much time to review all the training material online, sent through email, etc...
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 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.
The one thing that is always in our pocket is our cell phone, making data available faster and allowing us to respond quicker to data needs and notifications.
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.
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.
This mobile app can also capture protocol amendments, allowing different sites to be on up to date on their latest approved protocol version.
StudyPal mobile application was designed to digitally connect the Sponsor, Investigator & Patient. 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.