Learning by Doing: How I got a wake-up call by joining clinical trials

I’ve been designing and executing clinical trials for a long time - well over 25 years.  I’ve learned a lot over that time and refined many aspects of both the design and execution process. And yet for most of my career, I’d never been in a trial myself. Being in a trial as a participant allowed me to shift out of theory into reality, and I gained some insights I’ll never lose as a result of the experience.

A little more than a decade ago I was working in a global biopharmaceutical giant. It was, and is, an amazing organization, truly committed to changing how medicine is practiced. What surprised me most was the willingness and curiosity to change how employees did their jobs and related to each other. The organization started talking about and exploring growth versus fixed mindsets, using the concepts and research of Dr. Carol Dweck, to encourage employees to get out of their comfort zones.  The basic concept (apologies to Dr. Dweck) is that effort and challenge leads to learning. “Failing’ can lead to breakthrough thinking and learning if the conditions are created so that learning itself is the objective. That’s very different from how most of us were measured at school; a poor grade might lead a student to believe that they couldn’t master that subject and therefore they would no longer try. Of course, these concepts were not applied to determining safety and efficacy of new medicines. It was purely about how we collaborated and made decisions.

Here’s a simple graphic from Dr. Dweck’s website to explain growth mindset: 

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While we were exploring growth mindset, we were also exploring how to innovate trials to be more patient centric. And I was very lucky to be working on a global initiative to search out and test new technologies to change the way trials were designed and run. The goal was to ease patient burden and radically change access to trials. The secret sauce: our leader (who is still one of my mentors) set the framework that we would learn by doing, using principles established by John Dewey. Try - and fail at times - but always learn and apply the learning. It was like going back to Grade 1 or 2, but with the skills and knowledge of an adult, and trying to learn from a whole different perspective. So we designed experiments, set them up to de-risk while using Minimal Viable Product (MVP) principles, and aimed to fail fast or get a signal to go forward.  And we learned so much together about what seemed easy, what was actually hard, and what wasn’t ready to move forward…

Advance ahead a bit in time: patient centricity is a buzzword, wearables are ‘hot’, and I’m still experimenting with project teams, learning by doing. And then I heard about a bold tech driven study, which was just getting started at a new venture backed by big tech. This is a really ambitious 5 year trial that’s collecting vast amounts of data from participants, including digital data from wearables, and biospecimen data. The study tagline:  

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"We've mapped the world, now let's map human health."   

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Wow - that was a hairpin turn moment for me.  As in, instead of being theoretically curious, I signed up to be a participant. I actually registered to pre-screen and completed an electronic informed consent while I was in the conference session, listening to the project leader from the stage.  And as I read the consent form, I was thinking, No way can this mean 2 eight hour days at a clinic for the first visit. That has to be an exaggeration…It wasn’t. 

It took a while, and I actually stalked the study coordinator at Stanford to find out where I was on the waitlist, but I eventually got into the study.  And I’m so grateful to be in the study, partly for what I’ve learned about my health, but mostly for what I’ve learned about being a trial participant, rather than a trial designer and operator. 

It’s completely different on the other side of the research desk. I’ve learned to truly appreciate the compassion and care that the coordinators put into their daily work, and I’ve had the opportunity to ask lots of questions about what makes trials hard, what would make them better, and what they would wish for if they had a magic wand. I’ve had the opportunity to ask the sub-investigators why they are involved in the trial, what has surprised them, what they wish could be different. And I’ve had the opportunity to contribute, and see, a ton of data. Imagine having a wearable collecting your data over the course of 4 years. Annual site visits, quarterly wellness surveys, daily ECG collection, sleep data collection - you get the idea.  And, as a result of COVID, those annual visits are now a blend of telemedicine and in person visits. Then there are the tech support calls I’ve made when things stop working, I get a new phone, a new firmware update happens. All of these aspects of being a participant have informed my thinking about clinical trials. 

And speaking of COVID, I’ve been a participant in the Pfizer vaccine trial since August 2020. In fact, I started looking for a trial site the day that Pfizer announced their Phase III trial, so I got to learn (again) how to navigate the clinicaltrials.gov website and triangulate the data to find potential sites near me  - and I mean within 120 miles of me. Being in the vaccine trial has been equally informative and fulfilling, partly because of the relationships I’ve developed with the site staff. The trial isn’t using a lot of the technology and DCT solutions that I work on every day.  No criticism here - I understand why not (speed, globalization, constant study amendments). And things would be different if that trial was designed today, just two years later, because of all the learning-by-doing we collectively achieved about the use of technology in trials during pandemic conditions. I’ve had those conversations with both the study staff and other participants in the trials. We’ve shared our thoughts and experiences with the consent process, the sample collection process, the eDiary, and even the follow up schedule. The last time I signed the consent form it was the 19th amendment of the trial. We all agree that things would be different now.

So what’s the point? This is not about my participation. It’s about learning by doing as a participant, so that I can use those insights to advise teams on how to design and implement their trial strategies. I’m a healthy adult, and that is front and center in my mind every time I think about what we expect in trials. The ask of participants is much clearer to me now that I’ve had the opportunity to fill out those surveys, upload the data, take samples from home and have them shipped, and return to the clinic for study visits. We can design better trials and support strategies by putting ourselves in the patient’s shoes, and sometimes by becoming participants ourselves. We are all patients - some of us are participants. I invite you to learn by doing! 

Learn more about the role DCTs play in clinical studies: The Call to Action on DCTs: No Going Back