Author Angela Radcliffe
Advisor, Strategic Programs, Hu-manity.co
The other day I sent an article to one of my mentors for his advice. Considering myself to be an accomplished author and speaker, I was expecting him to maybe give me a few copy edits, refine a point or two and then heap some praise on me regarding my smart prose and compelling content. Instead, I got a rewrite and a dose of reality. He basically said, “This is full of words that only people in your space would really understand. Why are you writing for the echo chamber?”
After refuting his feedback point by point, picking apart the inaccuracies in his rewrite, and then stewing on it overnight I woke up the next morning, well- a bit more “woke”. It caused me to ask myself, “Why is it that we so often choose to write just for the echo chamber when we are hoping (to use his words) to infect the thinking of others with our insights and big ideas?”
Real World What?
The original article I wrote was on the recently released FDA framework on Real World Data and Real World Evidence. I filled it with my hopes and dreams about how having a more diverse and robust data ecosystem could transform clinical research. I shared my fears and warnings about how this was all at risk if we didn’t address the elephant in the room: our big data problem. I waxed philosophically on the relationship of big data to blood diamonds. I even threw in a Black Mirror episode reference for good measure. I was going for thoughtful, provocative and maybe even a bit witty – and in my echo chamber it probably would have worked.
But that is the problem. People in my echo chamber don’t need my opinion on the transformative power of RWE, they have been talking about it for years and now are faced with the realities of implementation. It is the people outside of my inner circle that need an approachable explanation of what modern medical research means and why it matters to their lives. They hear the term “big data” bandied about all the time but don’t really understand the “so what” unless we are raging hyperbolically about data breaches and privacy.
Unchain my heart? (Or at least my data…)
The key to leveraging RWE to create a cure for everything from cancer to heart disease could be locked away for good if we can’t find a way to stop talking only to ourselves. Here are two pragmatic tips for doing just that:
- Seek to educate the people “outside”. The people in your industry inner circle don’t need you to teach them what they already know. Ask yourself, would my Dad understand this? Would my best friend? My neighbor? If the answer is no, you might need to hit the delete key a few times. Continuing with the example of big data in medicine, we should ask ourselves: if the FDA has to define RWD and RWE for life science professionals, how can we expect the everyday healthcare consumer to know what it is? Have we taught others that big data in medicine is simply comprised of the details about our bodies, the impact of the drugs we take, and the information smart devices collect about our lifestyles? (In those words?!) Have we explained HOW this phenomenon of big data isn’t just a buzz word, but actually presents a promise to improve healthcare?
- Have the courage to ask the tough questions on the “inside”. Our networks are comprised of many smart people. We gain the most value when we have the courage to discuss the hard stuff. For example, While medical big data is promising, there is little agreement on who owns it and the question remains largely unanswered. There are many answers that have been given consideration, such as the doctor might own the data, the researcher owns the data, the hospitals own the data, or in some cases the healthcare insurance companies might own the data. However the answer that has not seen enough consideration as yet, is that the human might actually own the data. Moreover, the human might own the data as their personal property.
What is impactful about the FDA Framework around Real World Medical Data and Real World Drug Evidence isn’t the framework itself, rather the fact that it is a beacon of proof that this question has reached even the highest levels of the US Government. By attempting to clarify what RWD/RWE is, the FDA has joined the conversation.
Echo Chamber, meet my friend Fresh Perspective…
The implications of any answer to one of humanity’s biggest questions will likely shift markets, and in this case possibly what it means to be human. We owe it to ourselves to break out of the echo chamber that enslaves our limited thinking and link our virtual arms with all humans.
Big problems demand a partnership between the subject matter expertise that exists in our echo chambers and the new ideas a fresh perspective provokes. The ownership of human medical big data is now one of humanity’s biggest questions and it will take all voices to arrive at a sustainable solve. I invite you to add your perspective to this discussion.