Guest Column | June 19, 2018

Clinical Trial Design Is A Two-Way Street

By Megan Laker, advisor, Lilly Patient Experience and Design Innovation

Clinical Trial Design Is A Two-Way Street

You’ve heard the phrase “two-way street,” where a situation or relationship involves mutual give and take. Perhaps the first example that comes to mind is a friendship. But have you ever thought of clinical trial development as a two-way street? 

CoLAB is a clinical trial initiative that has been underway at Eli Lilly and Company (Lilly) for over five years. CoLAB brings clinical research teams and external partners — including patients, study coordinators, nurses, and physicians — face-to-face for a dress rehearsal of a clinical trial protocol.

Clinical trials are essential to the development and testing of new drug therapies; however, hesitancy and a lack of awareness exist among many people who might be eligible to participate. Studies have shown some people don’t enroll in a clinical trial because they don’t understand the purpose of the study or feel the clinical trial process is too long, complicated, and intensive. How do we change that dynamic?

During a daylong CoLAB simulation, Lilly invites key stakeholders to share their ideas about clinical trial elements such as planned medication dosing, study visits, and required samples. Through this program, Lilly hopes to assess clinical site and patient burdens to build simpler, more convenient, patient-friendly trials.

How do you create simpler, more patient-friendly trials? By soliciting and incorporating feedback from the experts — patients, caregivers, and site personnel — early in the protocol development process. CoLAB sets the stage for building better relationships with clinical trial participants. Relationships, both personal and professional, take time and energy.

To create the right environment for a successful CoLAB simulation, we follow a few “rules”:

  • Leave your title at the door.
  • When you come, you stay.
  • Think big; be bold.
  • Be present; engage.
  • Have fun.

“From the caregiver perspective, CoLAB is a very rewarding experience,” says Melissa Ewing, a recent CoLAB participant. “When we walked through the pros and cons of the draft clinical trial protocol, we had a chance to share what we felt would work and not work for the patients, families, and study coordinators. I felt like the Lilly study team really listened to the parents and took to heart what we had to say.”

Lilly also understands the important role healthcare professionals play in implementing a clinical trial. “I like to have a voice in improving any part of patient care,” says Donna Katz, a clinical nurse coordinator who has participated in numerous CoLAB simulations. “I really enjoy interacting with the Lilly folks during the CoLAB simulations. I was taken aback by how many Lilly personnel attended my first few simulations — people representing every department surrounding the topic from business, to design, to medical, to community liaisons — and they all came to listen. Their input was minimal — our input [the participants’] was the focus of the day.

“I have attended simulations where I was able to identify patient visit structures and/or procedures that would be burdensome on the research staff and patients themselves,” adds Katz. “As a CoLAB team, we were able to brainstorm various solutions that were ultimately implemented in the final protocol.”

CoLAB Simulations Help Us See Protocols From The Patient’s Perspective

Every study presents new and different opportunities to reduce patient burden. Lilly has changed clinical trial material packaging from blister packs to bottles for patients whose disease prevents them from getting pills out of childproof packs. We’ve also reduced the number of invasive procedures like biopsies and endoscopies, implemented simpler procedures, or eliminated them altogether.

Spending the day in a CoLAB simulation gives the opportunity to evaluate the length of certain clinical trial visits. Some planned clinical visits can be up to 12 hours long. To reduce the burden for patients, we’re now proactively planning overnight hospital or hotel stays for people traveling long distances to participate in our clinical trials.

Through programs such as CoLAB, Lilly researchers and physicians aim to better understand and embrace the patient’s point of view. We also realize other benefits like more communicative study teams; less rework, which results in lower costs; and shared learnings that can be applied to other trials.

What’s Next

In the future, Lilly is looking to apply the same CoLAB principles earlier in our clinical development process to influence study design and broaden external participation. We would like to engage a diverse set of experts on topics such as patient populations, objectives, and treatment, including combination and comparator therapies.

CoLAB challenges us to think outside of the box and make changes to clinical trials based on the real-life experiences of patients and research sites. And at the end of the day, the patient is at the center of everything we do.

About The Author:

Megan Laker is an advisor in the patient experience and design innovation group at Eli Lilly and Company. Megan started at Lilly 18 years ago as an analytical chemist. In 2005, she began applying her analytical and problem-solving skills to clinical trial management. Over the last 5 years, Megan helped develop the CoLAB program to support Lilly’s clinical portfolio across a variety of therapeutic areas and global regions by bringing the site and patient voice to clinical study teams.