What The Patient Voice Taught Lilly About Clinical Trial Design & Recruitment

By Joseph Kim, senior advisor, clinical operations and digital registry, Eli Lilly and Company

When you’re diagnosed with cancer, diabetes, an autoimmune disorder, chronic pain, a neurological condition such as Alzheimer’s disease, or another illness, having the safest, most effective medicine is paramount. Knowing a promising therapy is “in the pipeline” doesn’t bring you a whole lot of comfort. You want access to the most advanced medicines now.

Our industry is working to deliver breakthrough medicines as quickly as possible. One way we can speed the drug development process is to enroll patients in clinical trials faster. That’s why Lilly has embraced new approaches to engage patients as we plan and implement clinical studies.

Listening to and working alongside patients as we design clinical trials has provided countless valuable insights. Focusing on the patient voice often gives us entirely new perspectives on the design and conduct of clinical trials. Our goal is to use insights from patients to inform clinical trial plans and protocols, making participation easier and more appealing to patients and their caregivers.

Here are a few examples of our approach to patient engagement:

• CoLAB, a simulation where patients share their perspectives about clinical trial elements such as study visits
• Relationships with the International Children’s Advisory Network (iCAN) and the Institute For Advanced Clinical Trials (I-ACT) For Children
• Increasing diversity in clinical trial investigators and participants
• “Elixir Factor” podcast 
• Social media

Using Simulations To Optimize Research Protocols

Over the past few years, Lilly’s CoLAB capability has brought together our clinical research teams and external partners—patients, nurses, physicians, and study coordinators—for a kind of design-thinking workshop and dress rehearsal of a clinical trial protocol. During the daylong CoLAB simulation, patients and others share their ideas about clinical trial elements such as eligibility, planned dosing, study visits, and required samples.

CoLAB taught us that we must be easier to work with and sometimes we make things too difficult for the doctors and nurses conducting our research and the patients participating in clinical studies. CoLAB simulations have helped us discover protocol issues and identify potential solutions.

As a result of engaging patients and others through CoLAB, we’ve made changes to research protocols. For example, we’ve removed invasive procedures; assisted patients with devices to enable successful participation; added secondary endpoints of pain and other symptomatic relief to clinical trials; reduced the number of procedures or increased the timing between them; and designed new packaging to help patients track information about each pill, which may otherwise look similar to another medicine, to avoid the risk of inaccurate data.

But we recognize we can do even more to make participation in clinical studies more appealing to both investigators and patients. That’s why we are expanding the program from CoLAB to CoDESIGN, to incorporate external perspectives earlier in the clinical trial design process.

Forming Collaborations To Improve Pediatric Studies

Through our involvement with iCAN, Lilly has incorporated the perspectives of pediatric patients into, among other things, the consent and assent forms used when children participate in clinical trials.

Unlike adults, children—typically beginning around age 7—give assent, rather than consent, to participate in clinical studies. Parents give consent on behalf of their children. With input from iCAN, we created assent templates that tell the story of what it’s like to participate in a clinical trial. Similar to a picture book, the colorful template follows kids as they experience blood draws, X-rays, and other procedures.

By listening to iCAN network members, we also learned that youth expect clinical studies to include up-to-date digital health technology such as an e-diary or an app to help manage study visit appointments.

Earlier this year, Lilly became a sustaining member of I-ACT For Children. I-ACT For Children is a nonprofit organization focused on improving the quality, speed, and efficiency of global pediatric studies to address the gap in evidence on the best use of therapeutics in children. We believe collaborating with I-ACT For Children will help us accelerate the delivery of game-changing medical innovation for children.

Increasing Diversity Of Patients And Investigators In Clinical Trials

Because responses to medicines can vary depending on genetic background, ethnicity, gender, and other factors, Lilly strives to have diverse representation in our clinical trials. It’s a critical part of making medicines that will be the most effective for all of the people who will take them.

Unfortunately, minority populations have been underrepresented, historically and consistently, in clinical trials. Because of this, Lilly developed a clinical diversity strategy to, among other things, help increase enrollment of racially and ethnically diverse populations in clinical trials.

We’ve enlisted the help of Lilly employees to increase diversity in clinical trials, especially through the Lilly African American Network (AAN) and our Africa, Middle East, and Central Asia (Lilly AMECA) employee resource group. AAN members proposed a collaboration between Lilly and the National Center for Bioethics in Research and Health Care at Tuskegee University. Lilly AMECA is helping us establish connections with investigators in Africa, the Middle East, and Central Asia.

Increasing the diversity of the physicians who conduct clinical trials is a significant factor in recruiting study participants from diverse populations. We know, for instance, that people are more likely to volunteer for a trial if the investigator speaks their native language or is familiar with their culture. Lilly has also collaborated with The Center for Drug Development and Clinical Trials at Roswell Park Cancer Institute to train minority physicians to become clinical trial investigators.

Another goal of our collaboration with the Roswell Park Cancer Institute is to reduce cancer health disparities by increasing clinical research involving minority and underserved populations.

Connecting With Patients And Advocates Through Podcasts, Social Media

Our new “Elixir Factor” podcast explores the factors that inspire bold advances in science and the resilience required to change history. Podcast listeners learn how the Lilly R&D team collaborates with partners in advocacy, technology, academia, and policy to seek cures or solutions for the world’s most difficult diseases. Patients and advocates are frequent podcast guests. You can find this podcast through iTunes, Google Play, or another podcast app.

We also continually reach out to the public to increase awareness of clinical research and get their input about ways to improve trial participation. Through our social media efforts on Twitter, our @LillyTrials handle engages a growing audience of patients, researchers, innovators, and healthcare providers in a number of ways. We find and amplify valuable third-party content, generate our own research and content, live-tweet at specific research-focused conferences, and even moderate Twitter chats, like #whywedoresearch, which are well-attended by patient influencers and a testament to the trust we’ve built with them.

An interesting finding from our ongoing efforts to better understand the value of a virtual trial revealed that a healthy portion of patients would rather go to a clinic than have a nurse visit their home because of the additional stress caused by the perceived need to tidy up. That doesn’t mean virtual trials aren’t worth pursuing, but it does help us stay focused on the fact that having multiple options is perhaps the true hallmark of patient-centricity.

Looking Ahead

As new platforms and technologies become available, our industry should consider using them as tools to engage patients more fully in clinical trials. Regardless of the technology used, however, listening respectfully and completely—listening to learn and change—is key to patient engagement. Let’s all make (or renew) a commitment to really listen to the patient voice—to truly understand patient perspectives—as we design and recruit for clinical trials.

About The Author:

At Eli Lilly and Company, Joseph Kim focuses on developing digital health solutions for patients. He also serves as the host of Lilly’s podcast, Elixir Factor. He has spent more than 20 years in the pharma industry, integrating his experience working for sponsors such as Shire and Merck, clinical research organizations, and technology vendors. A well-known innovator in the clinical research industry, he was recognized as one of the “Top 100 Individuals” on the 2015 Medicine Makers Power List and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. Reach him at kim_joseph_p@lilly.com or @JoPeKim on Twitter.