Patient Reported Outcomes and Mobile Solutions

As stated in some of my previous posts, I have been working in the Life Sciences industry for over 8 years now. That amounts to a little bit over half my career till date. It has been a good journey with appreciation towards the greater good that this industry does in making people’s lives better. I agree that there is an image problem due to multiple incidents that compromised patients’ safety for profits or other trade-offs. However, all in all I personally think that there is much more good done than harm.

One thing that Life Sciences industry is not is “being technologically savvy”. Even this statement, if applied with in an organization, the degree of applicability changes from one business unit to the other. More than that, it has to be stated that the units that are “more regulated” are much behind in new technology adoption. The units that I have been working with the most is Research & Development (R&D). Even within this unit, the Research Teams, specifically Drug Discovery teams are more open to adopting new and advanced technology compared to the Drug Development teams.

As part of my day job, one of my goals is to continuously monitor new technology trends, specifically within the Life Sciences realm and help our teams develop new solutions and services. Identifying the solutions to be developed is not an easy job considering the economic constraints under which most companies are working in this “New Economy”. Luckily for me, another goal of my job is to find the right partners who would help us develop these new solutions and services so we can go to market faster.

One such partnerships is with a company that developed a Mobile Solution to enable Patient Reported Outcomes (PRO). I did a joint Webinar with them today titled “Maximizing Patient Reported Outcome (PRO) compliance in Clinical Trials – Leveraging Mobile Solutions“. While trying to put together a presentation that highlight the trends in Mobility adoption in general and adoption in Life Sciences and specifically Clinical Trials, I found out some surprising facts that the Mobile industry will be growing at a CAGR of 15.6% for the next 5 years (IDC Press Release).Also, according to another IDC report, Smart Phones will out sell the Netbooks, Desktops, Laptops and such combined in the next couple of years.

Patient Reported Outcomes (PRO) is all about getting information directly from the patients, without any interpretation  by specialists. In fact, FDA defines this as “A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response“. In my opinion, it looks obvious that leveraging the Mobile devices to run PRO trials improves the overall quality of data as well as the response time, not to mention the compliance to a large extent. The key is the coverage of last mile, i.e. enabling the patients to be reminded of any delays in submission of assessments. This will also open up a more personal service channel that can be leveraged to build a closer relationship with the patients.

As with adoption of many other disruptive technologies like Social Media, Cloud Computing etc. the regulatory compliance questions need to be addressed for any solutions developed to be used on Mobile devices. You can refer to my previous post titled “iPads, iPhones, Androids, Windows Mobile Phones, Life Sciences and Compliance” on what are the regulatory compliance requirements (specifically, guidance by FDA) to be considered in this context. The key is to ensure that the patient data collected is secure and the solution works in situations where the patient does not have connectivity. Also, the overall cost of the trial would come down considerably if the protocol permits ‘Bring Your Own Device (BYOD)” model for patients participating in the trial. Of course, this depends on the nature of the protocol and the trial design.

All in all, with the phenomenal up tick in Smart Phone sales, more so in ‘Pharmerging” markets like India and China which are also becoming the “Hubs” of future growth for Life Sciences companies, it is essential that Mobile solutions be developed and used to cover the last mile i.e. for the user touch points like Physicians, Patients and Pharmacies.

As always, your feedback and comments are welcome. I also encourage you to share Pros and Cons of the adoption based on your practical experience. I will be even more interested in any technological challenges you may have come across in the adoption process.


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About Venu Mallarapu

I am currently working as Director & Global Client Partner at Cognizant Technology Services in their Life Sciences division. I have over 19 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for over 13 years. I have worked with small to large pharma customers to address their business needs across R&D, Sales and Marketing and Manufacturing & Supply Chain areas. My passion is Pharma R&D. I blog and write about varied topics in Pharma Industry as well as latest Technology trends that impact Clinical Research and have also presented at various conferences and workshops on wide variety of related topics.

6 responses to “Patient Reported Outcomes and Mobile Solutions”

  1. Raj says :

    IMHO PRO device need not be tech heavy. To me any device that can 1.)Alert 2.)Remind 3.) ensure protocol compliance (recording time sensitive data for example or pain intensity as it happens) and 4.) Ease of use should get the job done. Of course compliance with regulatory requirements (the omnipresent audit trail for example). The real challenge is motivating the subject to record data and the psychometrics behind asking the right questions at right time. BYOD may actually be a preferred approach because familiarity and comfort of the subject with the entry device in itself is a major factor in successful outcome.

    • Venu Mallarapu says :


      Thanks for your feedback. You are absolutely right. Key is to make a channel available that will encourage and improve protocol compliance while at the same time reduces the cost but still maintaining the regulatory compliance.


  2. RJ Wirth says :


    We have had some success with collecting PRO data using email prompts (at times multiple prompts throughout the day) with a link to our web-based system (thereby requiring authenticated log-in). As for the “psychometrics behind asking the right questions at right time,” we have relied on our web-based adaptive testing platform. Such a system allows the PRO assessment to be tailored for the participant at the time of assessment. While there is still a lot of work to be done in this area, we believe that the psychometrics and the supporting technology is years ahead of what is currently standard practice in the health sciences. There is no practical reason participants cannot be assessed using any html rendering device at any point throughout the day. I think the biggest problem facing the field will be compliance. Simply put – participants get tired of answering multiple surveys every day.

    RJ Wirth

    • Venu Mallarapu says :

      Dear Wirth,

      Thank you for sharing your experiences and thoughts. I think the compliance aspect you have mentioned is definitely one of the root causes. That is where the ability to access these surveys anytime, anywhere will improve the overall experience of the patient and will encourage them to be more compliant than otherwise. Please keep your feedback coming in. Appreciate your time.


      • RJ Wirth says :

        I agree – the assessments have to be easily assessable, easy to navigate, and short (without compromising psychometric rigor).


  3. Maribeth Dugdale says :

    The Physician-Patient Alliance for Health & Safety (PPAHS) is an advocacy group dedicated to improving patient health and safety. Doing so involves many facets. Hospitals need to leverage technology to provide necessary monitoring of patient vital signs. Management needs to enable healthcare providers to reduce safety risks by implementing procedures centered on patient safety. Physicians and patients alike need access to information on patient safety and must take an active role in preventing adverse events.”

    Remember to have a look at our new online site

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