Author: Sarah Iqbal
Studies show that mobile tools increase trial engagement while lowering costs.
You are holding the most important medical devices of the future in your hand: a smartphone and a mobile app.
As the clinical trial space explores ways to leverage the personal and ubiquitous nature of mobile phones, it could also find a solution to two of its biggest challenges: patient engagement and the high cost of recruitment. The integration of mobile technology in clinical trial design is a fast, efficient way to align patients’ needs with study objectives.
Mobile apps are being created for use in clinical trials, connecting every patient with a smartphone to clinical trial information, participation opportunities, and tracking and monitoring capabilities. Mobile apps connect participants easily to electronic data capture and clinical trial management systems, as well as imaging and reference sites. Studies show that this extreme connectivity can improve participant compliance and overall patient outcomes.
Case Study: Cluster-randomised trial using a mobile phone to personalize behavioral intervention for blood glucose control in Maryland¹
Maryland, researchers conducted a cluster-randomised trial using a mobile phone to personalise behavioural intervention for blood glucose control to test whether adding mobile application coaching and patient/provider Web portals to standard diabetes management would further reduce glycated hemoglobin levels in patients with type 2 diabetes.
The Mobile Diabetes Intervention Study randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in the analysis. The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual care group, a difference of 1.2% over 12 months.
The study concluded that the combination of patient behavioural mobile coaching with blood glucose data, lifestyle behaviours, and patient self-management data individually analysed and presented substantially reduced glycated hemoglobin levels over one year.
Pharma is just beginning to realise this benefit of how mobile technology can optimise clinical trials. According to several industry experts, mHealth technologies hold great potential to accelerate trials, reduce risks, and drive down costs.
mHealth technologies enable continuous monitoring that can have an immediate positive impact on patient safety. With vast and accurate information streaming in real time, researchers can more quickly identify potential adverse events or side effects, such as changes to heart rate, heart rhythm, blood pressure, or sleeping patterns, after taking a medication or therapy and take action to intercede. This capability also has promising application in post-market surveillance.
In addition, access to real-time information can support adaptive trials, providing early indications of changes that might need to be made to protocol, sample size, or trial scope, Similarly, trial sponsors can have earlier insight into a therapy that is performing better than expected, which would accelerate the delivery of life-saving treatments to market.
Big data and patient recruitment in clinical trials
The amount and quality of data captured from a tap of the finger on a smartphone is a virtual goldmine for pharma, especially when it comes to patient recruitment in clinical trials. Pharma companies today are reaping the benefits of technology in healthcare — from the immense amount of data available through electronic health records (EHRs), practice management systems, and electronic claims, and making smart connections to doctors and patients or using technology to get face-to-face with customers, the ability to use technology to expand their reach and increase efficiency is highly appealing.
This use of technology has never been more evident in playing a key role in the area of patient recruitment for clinical trials. Slow patient recruitment and retention for trials can mean hundreds of millions lost for companies due to the lag time in product approvals. However, new ways of targeting doctors and patients for trials has emerged using real-time clinical data.
Slow patient recruitment and retention for trials can mean hundreds of millions lost for companies due to the lag time in product approvals.
On the patient side of things, there are several apps that help them find and sign up for appropriate clinical trials right from their smartphone. Apps such as Clinical Trial Seek, My Clinical Study Buddy ®, and Study Scavenger are some apps where patients and physicians can look for trial information.
With mHealth technology like this at work, pharma companies can keep clinical trial subjects more fully engaged. Additionally, using mHealth technology, study protocols can be set up with flexible schedules that can be fixed, randomised, or event or self-triggered. Schedules can be set up for hourly, daily, weekly, or monthly events. Surveys can consist of single quick questions or complex instruments with conditional responses. Diary entries can be established for study biomarkers and these can be either initiated or validated by other external devices that also report to a control center. Educational programs consisting of podcasts or other Web-based content can be scheduled, shared with professional and family caregivers, and even tested within the system, he adds.
Simple web management of content allows researchers to insert and change medication schedules and reminders, customisable surveys, podcast-style education modules, and intervention activities on individual smart- phones quickly and easily. Data are captured in real time and other study activity is tracked. Also, non-compliance can be identified and action taken to quickly bring a trial participant back into compliance. There is benefit in knowing in real time when and if a dose was taken, as well as knowing what the other treatment markers are before, at, and after the dosing.
1. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care 2011;34:1934–1942 - November 01, 2013 .Web.