If you will have a pharmaceutical brand in the market in 2015, you should be planning the clinical trial strategy for your app now

Geoff McCleary discusses the importance of planning the clinical trial strategy for your app for future pharmaceutical brands.

Do you have one? An app that is.

Is there a behavioural component of the condition your patients suffer from that negatively impacts their overall health outcomes? Or would they simply benefit from help taking their medication more regularly. Either way, with over 90,000 medical apps in app stores globally, someone else may already have an app for that.

It’s time for Pharma marketers to get on board. We, as digital marketers, frequently find ourselves using words like “meaningful use” and “demonstrated outcomes,” which indicate that ‘results’ are going to be more important in the coming years than ever before. If a patient can improve their health outcomes through treatment, it will no longer matter if that “treatment” is chemical, or digital in nature. A proven outcome will trump all. That’s why today, it is becoming increasingly likely that a programmer, start-up, or competitor, not only has an app, but is at some stage of planning a clinical trial to demonstrate outcomes.

“Will our brand be prepared to compete with mobile software and tools in the coming years?”

Two questions Pharma should be asking itself now are: Will our brand be prepared to compete with mobile software and tools in the coming years? And how can an app bring value worthy of a clinical trial?

Let’s look at the case of WellDoc in the US. WellDoc develops next generation technology to support chronic disease management. They conducted a clinical trial for their mobile (based) diabetes management programme (BlueStar) in 2011-12. In this clinical trial, they were able to show that BlueStar use demonstrated a 1.9% improvement in patients’ ability to manage glucose levels. Under two percent may not seem like much, but when it becomes 2% of the estimated $245 Billion in diabetes-related treatment costs each year, that’s an outcome worth supporting. And support they do. There are now at least three payors covering the $100 / month fee for their patients in an effort to reduce these costs.

Healthcare apps are gaining more and more attention with physicians and patients alike. They have a credible voice in the patient / physician conversation in the exam room. In a study of mobile health consumers this summer, we found that in the last year, over 35% of patients had a conversation with their physician about apps for their condition during the exam. The result of such conversations? Over 90% of those patients ended up trying the app.

“…over 35% of patients had a conversation with their physician about apps for their condition…”

That high interest and willingness to try apps extends beyond those who bring it up with the physician. In fact, nine out of ten overall respondents indicated that they would take an app if the physician recommended it to them.

So what are your options?

As of now, there are three main app strategies that you can pursue.

1. Condition support

2. Standalone branded app

3. Branded pill+support

Condition support apps are generally patient tools and content that can range anywhere from tips and tricks to coordinating care to treatment logs or pill reminders. These apps can be focused on a single condition or run across multiple conditions in a franchise or enterprise.

WellDoc is by no means alone in this category; they share it with many others Cellnovo, recently announced CE mark approval for its diabetes management mobile device, and The National University of Ireland in Galway, Ireland is currently conducting a double group, randomized controlled trial of the app Accupedo to determine if an app can improve fitness by increasing the number of steps a patient takes each day. Both are excellent examples of condition apps and demonstrate what third party developers will most often be developing.

Condition apps represent the largest potential digital threat to the brand as a clinical trial of these apps is not done in conjunction with any specific treatment. So outcomes proven by these apps may compete directly with the outcomes provided by a drug.

“…nine out of ten overall respondents indicated that they would take an app if the physician recommended it to them.”

Standalone branded apps may function as a digital extension of the brand, or may function as a unique brand with its own value. Either way, these types of apps do not go through clinical trials in conjunction with a brand, but may be promoted similarly to a pharmaceutical drug.

For the bold and forward-thinking, you may wish to consider a pill+support offering that combines an adherence focused digital app/service in a post-marketing clinical trial with a specific drug. Completing a trial of this nature, while a potentially onerous undertaking, may provide some additional differentiation and defensive opportunities for the brand. What is the patentability of an app? How long might exclusivity on software last?

As you begin, or conclude planning this year, keep the future in mind. The space your brand competes in may be vastly different 18-36 months from now. Your share may be at risk from new, digital therapeutics that have nothing to do with a drug. A physician’s decision to write your drug may be delayed months because they want to try treatment with an app. If you started today – with development, trial, and approval cycles as they currently are – you may be ready to launch your new approved digital treatment just in time.


About the author:

Geoffrey McCleary is Vice President/Group Director of Mobile Innovation at Digitas Health. More than 15 years of pharmaceutical and interactive marketing experience enables Geoff to provide the most strategic mobile and technological insights to the world’s largest pharmaceutical and biotechnology clients. As a leading mobile marketing evangelist, Geoff has established himself as a proponent of using social media and emerging technologies to create meaningful connections with patients, consumers and physicians.

Before joining Digitas Health, Geoff led the strategy consulting practice for a leading mobile marketing agency within the pharma industry. Prior to that, he led the Mobile Marketing Center of Excellence at imc Health & Wellness.


Will your brand be prepared to compete with mobile software and tools in the coming years?