Think patient

Just imagine I am being asked to take part in a clinical trial. It will run for 2 years. I am asked to use a provided smartphone to fill out a daily diary for a number of months.

Now... like many people these days, I already have a smartphone. I'm an iPhone guy. It fits in my left pocket. I keep my keys and money in my right pocket - I don't want to scratch the screen. I charge it more than once a day.

I don't think I want to carry around another device... My pockets are already full. I really don't think I could routinely charge 2 devices...

In a clinical trial setting, being asked to use a 2nd device is negative engagement and a barrier for my participation.

Changing Engagement

I use Facebook. I used LinkedIn. I use google search. I do all these on my laptop, tablet and PDA. I expect to be able to use any of them depending on the situation. If I am sitting down at my desk, or filling out larger forms, I will use my laptop. I like that I can use the solutions from these companies on any device. I am engaged with these companies and use their services all the time.

In clinical trials, patient engagement is really important.

It is no longer a barrier to use technology in clinical trials. It is a barrier if you do not offer technology that fits in with the patient’s lifestyle. Paper documents or additional electronic devices will be a significant barrier to most people.

Negative clinical trial experiences will affect recruitment, compliance and retention – all the things that are most important to sponsor companies conducting research.

As a patient in a clinical trial, I want to use any of my online devices.

Let me give you a real life example of positive engagement.

John has Multiple Sclerosis. Despite the seriousness of his condition, he is upbeat and wants to be actively involved in decisions regarding his treatment regime. 

John is informed of a clinical trial – he receives a study invitation via  email. This is a referral John receives from his doctor for a clinical study opportunity his doctor thinks might be appropriate. He clicks on the link while he is travelling... The link opens in a browser on his mobile device. He quickly completes a simple pre-screener on his mobile to find that he may qualify for the study. Great news.  

Back at home, he surfs the web on his laptop. Whilst doing so, he receives a notification email and sees that it is a message from the study investigator. He confirms that John may be eligible to join the study evaluating a new treatment that could help John manage his condition better. The investigator asks John to complete an additional form regarding his medical history and current treatments. This electronic form is longer than before, but John is keen to be involved. He completes this extended form on his laptop as it is more convenient.

A couple of weeks later, John meets the investigator during a site visit to conduct some final assessments to confirm that he meets all of the the inclusion / exclusion criteria and he is enrolled in the study. He has the option to receive all of the study materials through a patient study portal - he agrees.

Back at home, he logs into the patient study portal. It gives him access to all the information about the study, he sees the electronic Informed Consent including a video with further information about the conduct of the study. John can electronically sign his agreement to join the study and share his information. The system tells him that the investigator will soon counter-sign the form. John can see from the interactive study guide what is going to happen next, and the procedures that will be followed.

When he is on the move, he accesses his study portal via his mobile. He is reminded about data entry and study visits so it is easy to keep track of the things he needs to do. If he has any questions, he can easily get in contact with the study site via the same secure portal.

Thats engagement. 

The above example is modelled on a standard Clinpal implementation with
             Recruit, Engage and Educate modules utilised