Around the world, medical device and pharmaceutical companies practice the hallowed rites and rituals of designing, executing, and submitting clinical trials for regulatory approval. The recipe is well known: perform a literature review to assess previously published trials, meet with key opinion leaders and payers to devise meaningful endpoints, negotiate those final endpoints with the U.S. Food and Drug Administration (FDA) or another national regulatory body, execute the trial, and submit the data for approval. If all goes well, a company achieves approval for their product, and it changes the lives of millions of consumers who are afflicted with a disease.
Wait a second. Did someone say consumer?
Yes, the end-user of the actual product — the consumer (some call them “patients”) — is absent from the design of most clinical trials. Healthcare systems around the world have historically been top down: what the physician (or sometimes, the payer) says, goes.
This void is beginning to be filled with a chorus of voices demanding to be heard. They are healthcare consumers who challenge the status quo by doing their own research, engaging their physicians in dialogue, and holding the scientific community to high standards. Some have even begun to impact the design of clinical trials while others have started to run their own trials, blazing the so-called “DIY Clinical Trial” path.
These “e-Patients” represent a sea change in our healthcare system. With the rise of high-deductible health insurance plans, more consumers are paying out of pocket for their care, and as a result, need to be convinced that they are getting the best bang for their buck.
The FDA has now launched a “Patient Preference Initiative” to bring consumers into the device development and testing fold. But the responsibility to involve consumers in the design of clinical trials rests with industry. In almost every other business, understanding consumer sentiment and earning consumer trust is a top priority.
Our own experience at Allurion Technologies tells us that healthcare should follow suit. When we designed the FDA trial for our weight loss product, we couldn’t come to a consensus on the best path forward. On a lark, we fielded an online survey that described three distinct potential trial designs in simple language and posed a question: Which of the following designs would you be most likely to trust?
- An unblinded study involving only one group of patients in which subjects would receive our product and have their weight measured on a monthly basis.
- An unblinded, randomized, controlled study in which subjects would either receive our product or be enrolled in a lifestyle modification program. Weight loss results would be compared between the two groups at the end of the study.
- A randomized study in which subjects would either receive a sham (fake) version of our product or the real thing. Weight loss would be compared between the two groups at the end of the study.
Going into the survey, our guess was that the first option would be the most appealing to someone interested in losing weight due to its simplicity. While it was the least scientifically rigorous, it was most emblematic of the real world. However, to everyone’s surprise, option three (the most complex and thorough) was the favorite.
The design and execution of clinical trials represents an ideal opportunity to engage the consumer and begin building a relationship that can last a lifetime. Sometimes, to get the conversation started, all we have to do is ask.
Shantanu Gaur, MD is the co-founder and CEO of Allurion Technologies, which makes a gastric balloon for weight loss.