-->

Sep 1, 2015

The Patient is Missing

Clinical volunteers can choose to walk away 
any time they want and to clinical 
trials they may be irreplaceable.


by Amy Musolino
Program Director, New Service Development
Fisher Clinical Services


Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.
Pat was the keynote speaker at a recent Insights event and presented the topic “What Does it Really Mean to be Patient Centric?” During her presentation, she discussed the new buzz word in the industry right now, “patient centricity.”
But are they really patients at all?
Pat gave the audience a point to ponder. She doesn’t view the people she treats as patients at all.  In fact, she reminds herself and her staff that, in actuality, what they are is far different—they are volunteers. It’s a simple change in verbiage, but a powerful distinction. When you think of a patient, you automatically tend to think of someone that needs you to care for them. They need you. But in fact, in our industry, it is us as clinical research professionals that need them. Volunteers can choose to walk away any time they want, and to us they may be irreplaceable.
What would we do differently?
You’re probably thinking this is intuitively obvious. We already know they are volunteers (even though we don’t really refer to them that way). Or do we? Pat shared with the audience countless stories and examples of instances when it seems somewhere along the way we may have forgotten that they were volunteers. I found myself standing in the shoes of her patients, wondering if I would have stuck around sitting in an office for 8 hours with my 5 year old; waiting for a pediatric vaccine to arrive when it was supposed to be delivered at 9 in the morning. I’m not so sure I would.
This article is related to the Whitepaper: Clinical CAPA - Embedding Quality into Clinical Research To get the full details, please download your free copy.
When making clinical supply decisions, are we forgetting about the volunteer? If we had really been thinking of them, would we have picked the same packaging? Would we have made it easier for them to open and keep track of? Or perhaps smaller so it was easier for them to carry? Would we create the same label or would we use color to make it easier for them to read critical text?
Would we make ourselves more available for assistance? Would we know for sure where our drug was at any moment, while being more proactive about communicating exact delivery times when we know volunteers are waiting?
Clinical supplies are at the heart of the volunteer experience.
In the end, clinical supplies have the most profound impact on the volunteer—over anything else we do. Patient Centricity sounds good and makes us feel good, but are we truly taking meaningful action to drive an industry culture that puts the volunteer first?
I have heard some great examples of industry leaders that are striving to do just that. However, I would love to hear more. In the space below, share some examples of industry best practices that you have seen and we can all learn from. 


Amy Musolino has more than 14 years' experience in the pharmaceutical industry.  Her pharma career began at Mallinckrodt Baker in 2000 where she served as product manager for high performance bulk and laboratory salt and excipient products used in biopharmaceutical manufacturing and research.  Amy then spent years several years at Covance serving as the Phase II/III and IRT brand manager.

In 2010, Amy joined Fisher Clinical Services as program director of new service 
development, where she has worked to enhance and expand the Fisher Clinical Services service portfolio in order to deliver services that meet the evolving needs of the 
pharmaceutical industry. Amy holds a Bachelor of Science in Engineering from Cornell University,  an MBA in Marketing and Masters Certification in Supply Chain Management from Lehigh University.







Watch Related Videos

Download Free Resources
White Paper: Understanding ISO 13485: A Brief, Yet Comprehensive, Overview
White Paper: 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?
Webinar: Risk Management: FDA Regulated Industries