Patients are confused and afraid of clinical trials:
Every revolution has officers and foot soldiers. When you get too many officers and not enough foot soldiers your revolution will likely stall. This is the situation we face in the biotech world. We have more capital, more entrepreneurs and more professional scientists with greater insights than ever before. However, the Wall Street Journal reports our industry’s ability to recruit patients is at an all-time low. A recent study conducted for Memorial Sloan Kettering indicate the majority of Americans have an unfavorable opinion of clinical trials and other studies show only 4% of patients sign up for trials of new cancer therapies. Jose Baselga, MD, PhD and Chief Medical Officer of MSK says, “If this trend of low enrollment continues, we will face a crisis in cancer research and discovery. Further education is the key to participation and progress.”
What to do?
We can help transform patients from “powerless to participation”.
Benjamin Franklin was the original citizen scientist. He embodied the definition of a scientist as someone who thinks about the nature of the world in order to devise ways to better the lives of others. In this, he was incredibly successful. American Scientist’s Shawn Carlson suggests, “Franklin was the first person to prove that pure science could benefit ordinary people.”
Could we “Be like Ben” was, “glad of an opportunity to serve others”?
Franklin invented the lightning rod, bifocal glasses, and the flexible urinary catheter. He patented none of them, saying, “…as we enjoy great advantages from the inventions of others, we should be glad of an opportunity to serve others by any invention of ours; and this we should do freely and generously.” We now understand the economic value of patents to reward innovation. The generosity we desperately need now from citizen scientists is for doctors, caregivers and patients to engage in trials to evaluate the incredible breakthrough therapies that are now entering the clinic.
We live in a Golden Age. Our body can serve as our laboratory.
In Kevin Kelly’s terrific new book, “The Inevitable-The 12 Technological Forces that Will Shape our Future”, one of the forces is: “The global technology revolution is being advanced by users and not by corporations or governments.” He further states that “The funny thing about a whole class of technology that enhances experience and personalization is that it puts great pressure on us to know who we are.”
The Quantified Self is addictive:
The power of modern technology like wearable or remote health devices has magnified the power of citizen scientists to move humankind forward. You don’t need to have advanced degrees or be published in peer-reviewed journals; you just have to be curious, willing to take risk, be engaged and share. Today there are 200 Quantified Self Meetup groups around the world with over 50,000 members. They are the vanguard.
Get people in the habit of sharing their personal data for the greater good.
Tom Steen, CEO of Adjuvant Research Services, a clinical research service provider, believes trust in a physician is a main reason patients decide to participate in a trial. Unfortunately, primary care physicians rarely recommend participation in clinical trials. He wonders whether our industry should take the long-term view and devote resources to engage primary care physicians in educating patients and enrolling healthy subjects in citizen science projects. Once someone has experienced a low risk trial as a healthy volunteer, they might be less risk averse and have more awareness to seek out participation in a trial when they are sick. The MSK survey confirms this. It showed education makes a “measurable and immediate difference”. After reading a brief statement defining clinical trials, the number of respondents who had a positive impression of clinical trials jumped significantly, from 40 to 60 percent. A small investment in education could make a dramatic effect on patient enrollment.
Do you care enough to challenge the status quo?
Greg Ambra, VP of Clinical Operations at DZS, a full service CRO, says, “We, the professionals in the Biopharm industry are also citizen scientists. We need to do more to challenge the status quo. With the ability to capture data directly from patients advancing so rapidly, we need to find a way to incorporate patient friendly technology in our clinical trials.”
Could it be fun, cool or life-saving to be a citizen scientist?
I have made my first baby step towards adding citizen scientist to my credentials. I participated in the American Gut Project the world’s largest crowdfunded citizen science project in existence. I joined more than 6500 participants and we raised over $1 million to map the American biome. I learned a lot. It turns out that the microbes within us are much more than quiet residents; they are an inherent part of our physiology and critical to the development and maintenance of our immune system. Once this data is collected and digitized it can be used to compare to other nations populations and provide valuable data for sub-populations like vegans and omnivores. I am now thinking about my diet in context of improving my microbiome. Kelly tells a more dramatic story where computer scientist Larry Smarr tracks “…about a hundred health parameters on a daily basis. Every month he sequences the microbial makeup of his excrement. Smarr self-diagnosed the onset of Crohn’s disease, before he or his doctors noticed any symptoms.”
Patient Advocacy Groups to the rescue?
The pace of drug innovation is being slowed by the difficulty in recruiting and retaining patients. Bob Albanese, Senior Vice President of CSM, a pioneer in Direct to Patient drugs for clinical trials believes advocacy groups like Michael J. Fox Foundation and their Trial Finder hold the key to greater awareness and participation. I am eager to learn more. Please email me if you have ideas on how the pharma industry can increase awareness and engage Americans to help us deliver faster cures.