Adapting Trial Recruitment to Fit Patient Needs

Mascherino2014-156w-2The following is an interview with Liz Mascherino, an Advisor in Lilly’s Clinical Innovation Group. Liz focuses on building solutions to harness the power of the internet to drive patient engagement around clinical research. She works to set realistically aggressive enrollment goals during the study planning stage, and uses smart, data-driven patient engagement strategies to achieve those goals.

Lilly is evolving how it engages and recruits clinical trial participants. What triggered the desire to innovate in this particular area?

Patient recruitment has long been a challenge in clinical trials, for us and everyone else in the industry. Not much has changed in this regard. But what’s new is we see an exciting opportunity to not only overcome this challenge, but also to improve the patient experience. Patients are heading online for health care information, and the availability of this information has empowered them to take a more active role in their health care. The rise of the empowered patient is an important development for clinical trial recruitment.

How so?

We need to adjust to meet these new expectations. Today’s patients increasingly view autonomy and access to information as important elements in a good patient experience. Clinical trials are no exception. Patients should have access to quality clinical trial information, right alongside other health care information, so they are empowered to make the choices that are best for them. By meeting these patient expectations, we can also improve clinical trial enrollment. In the past, patients wanting to educate themselves about clinical trials or find trials would have to be extremely motivated. Now all they need is Internet access and a little curiosity. If we provide valuable and relevant clinical trial information for patients, they become newly empowered to consider clinical trials as an option.

How has this trend of empowered patients influenced your approach to innovation? 

It means that patients and caregivers are the focus of all of our efforts. We certainly hope that clinicians find value in our work, but we aren’t specifically targeting them. Patients and caregivers are really central to everything. Practically speaking, this approach means presenting information in lay-friendly language, trying to address topics of interest to patients and caregivers, and being visible where patients and caregivers already are.

Can you share a Lilly project aimed at improving how we engage and recruit patients?

One example is Lilly TrialGuide, a website for patients that we launched late last year. Lilly TrialGuide provides general clinical trial education, as well as a permanent home for information about Lilly studies. As a permanent presence, it’s a reliable place for patients to learn about clinical trials, and it’s something we can build and improve over the long-term. It’s also a foundational element to support our future plans for patient outreach. Lilly TrialGuide deviates from what we and other sponsors have done in the past -- a “one off” website for each study. These study-specific websites are built right before a trial opens for enrollment, and they are torn down once enrollment completes. Typically, educational information on these websites is sparse, and they provide no way for patients to follow the lifecycle of a clinical trial.

How is Lilly TrialGuide designed to meet patient needs?

We put a good bit of thought into how to meet patient needs and we have plenty more work to do in this regard. But from the beginning, we've wanted to make sure Lilly TrialGuide: 

  • Had a look and feel that felt warm, inviting, and credible
  • Presented content in a way that seemed accessible to patients
  • Contained high quality and engaging educational material
  • Presented our research clearly and concisely, in a way that was easy for patients to find
  • Made it simple for patients to take the next step if they are interested


To help us attain this vision, we’ve involved patients and the public throughout design and development. For example, early on we did virtual focus groups with patients to help us gather design and feature requirements. More recently, we conducted user testing on the website to understand how we could make the design more intuitive.     

What future plans do you have for Lilly TrialGuide?

A lot! In the short term, here are some of our plans:

  • More Trials: The initial rollout included a limited number of Lilly trials but the site will eventually have all Lilly trials.
  • Globalization: Lilly TrialGuide launched as an English-only website for a US audience, but we are expanding to other languages and countries.
  • New Features: We’re continuing to add features to enhance the visitor experience. For example, patients will have the ability to receive alerts when clinical trials are added or results are posted.
  • More Content: We plan to expand the information we provide, especially as it relates to particular segments of patients or needs.


What have been some of the challenges of innovating in this area?

Many of our challenges are typical of innovation work in pharma. For example, we’ve run into existing business processes that were difficult to integrate with our work. So we had to figure out how to either adjust those processes or our own approach before we could move forward. And of course legal and compliance issues have come up that we’ve had to address. But we expected to run into these kinds of challenges given the nature of our work.

A less familiar challenge has been rethinking how we connect with patients around Lilly trials. Engaging with patients online is nothing new for us. We’ve had this blog and a Twitter presence for a few years now. But we’ve not really tied that engagement to our clinical trials or to patient recruitment. As we think about Lilly TrialGuide and related projects, we’re having to reconsider standard recruitment practices. But these are challenges we’re thrilled to address. We’re excited to create more meaningful interactions for patients considering research participation.