On Tuesday, August 9, I had the great pleasure of meeting with some of the folks who make up the Clinical Innovation Team at Lilly. I definitely got more than I had expected to out of the day and have struggled with how to appropriately summarize and share what I learned and am still ruminating on – there will definitely be more blog posts on these topics!
I think it’s important to start with the strategic objectives of clinical innovation at Lilly, as I understood them:
- To go faster – right person, right drug, right time, every time (I like this! This feels right!)
- To deploy resources that create value (Who defines “value”? Is there an opportunity to personalize this definition?)
- To create a new mindset, methods and motivation (What’s wrong with the current mindset, methods and motivation? How will we know a change will be an improvement? What could be tested on a small scale so as to not upset an entire system by implementation of a solution that’s actually not an improvement?)
- And to sustain the flow of innovation (Why not strive to improve the flow of innovation?)
These would emerge as pillars for the day as I learned how different members of the team focus on different parts of these strategic objectives to avoid complacency and show agility in their effort for continuous improvement.
Lilly has a clinical innovation team larger than any other in the industry. Learning about their dedication to “engage with patients” rather than simply “engaging patients” should be commended. So much time is wasted in healthcare trying to get patients to “engage in”__________(fill in the blank). It's stuff others may think is important but is not relevant or a priority in my life. I think great strides can be made by meeting the patient where they are rather than where you want them to be and engaging in their lives and interests. A person who feels understood and appreciated will always do more than what is expected.
Understanding the structure of the clinical innovation team with members dedicated not only to patients and researchers before, during and after the clinical trial process, but to people before they ever become patients is definitely impressive. I wish I had more time to learn about the personal stories of the folks I met with, to understand how many of them bring their focus from experience in either being a patient or caring for “patients,” and encourage them to channel those experiences in their work. I think people forget that we’re all patients, really.
I recently wrote on my personal blog about some of the frustrations with participation in clinical research, highlighting issues with awareness, accommodation, participation, and feedback. It felt hopeful to hear about efforts underway to educate the community about the importance of clinical trials and clinical trial participation, and support through the process (Lilly TrialGuide), and the growing program to provide Plain Language Summaries to let study participants know when the trial has ended and what happens next. Signing up for studies through their eConsent and Tiered eConsent is something that I hope will spread to be embraced by all researchers requiring informed consent for their research. These are fascinating tools for a wide variety of health literacy levels focused primarily on the risk-benefit considerations. Best of all? They let patients decide the level of information that they want, a simple yet powerful offering. That’s all we really want – some autonomy and authority to make decisions according to our own priorities.
Returning individual research data back to patients is something the Clinical Innovation team is exploring to better understand what it would take to do this, given the complexities involved. As a parent, I would want the following information at the end of any study my son has participated in: What treatment he actually got, how he did on it, any labs and vitals that were taken that could be of value to me in managing his care, a summary of what was learned and any other study related data organized in a way that is both useful and actionable. I would also like to understand the plan for going forward. I can appreciate that not everyone will want this, but believe that it should be available for those of us that do.
In addition to their focus on the people who participate in clinical trials (or “participants” or “subjects” as they’re often referred to) the Clinical Innovation Team is focused on research professionals, helping them to grow professionally in their reach and influence. There appears to be much effort toward engaging all audiences, and telling the story of clinical research in an authentic voice from all perspectives.
I have spent some time thinking about this, appreciating the effort toward creating a comprehensive voice, but left wondering about the story that will emerge by simply collecting the voice of folks that fall into the different areas of focus: people before research, participants in a clinical trial, researchers, patients who’ve participated in a study. How will we weave together a story of clinical research that’s not simply chapters from the varying perspectives, but rather a comprehensive chapter written together used ultimately to identify our collective strengths, the benefits we all share, and the areas that are painful and unnecessary that we should find a way to get rid of? Maybe the efforts of this group could be on connecting patients and researchers rather than helping them individually. Clinical research wouldn’t be possible without us, the people who participate in and often rely on research as a treatment option, but it also wouldn’t exist without the dedication of research professionals valiantly striving to learn something new to help people who are sick. I think research is collectively “ours,” as one can’t exist without the other. If these stories of the intersections between these groups are better understood, perhaps design could be enhanced and we could learn more, faster, and turn research into practice ultimately helping more people to be well.
One overarching theme of the day was that the best solutions in clinical trials are personalized solutions for the entire health care community. This is my passion, and one of the four strategic objectives that we discussed early in the day. The breadth and depth of the conversations that I had last week went beyond clinical innovation in drug development to the shared humanity that we all have as people in the world trying to do good. I am eager to return to continue many of these conversations and join in the efforts to improve.
I’ll end with a few parting thoughts:
- How might we get medications to patients faster without compromising the integrity of the development of that medication?
- How might we reduce the logistical burden of clinical trial participation to enable participation as a part of daily life?
- How might we embrace the value of learning from failure instead of only celebrating success?
- How might we enhance learning by sitting at the intersections of the different stakeholders in clinical research?
I’d love to hear your thoughts on these ideas! What do you think? And what would you like to hear more about?