COMMENTARY

Can Real-World Experience Become Real World-Evidence (RWE2)?

Hello and welcome. I am Dr George Lundberg and this is At Large at Medscape.

Back in the mid to late 1990s, many of us were busy inventing the medical Internet to take advantage of the newly available World Wide Web. To do it right, some of us insisted that we quickly develop the ethics that would underpin the medical Internet. To do that, we drew from the established principles of the ethics of medicine, journalism, medical journals, and, believe it or not, business. Various codes were developed, widely applied, and generally have been successful.

Moving from the rigid, fixed medium of paper with unidirectional capability to a potentially interactive, conversational, multidimensional, multimodal, and multidirectional medium—the Internet—was an experience that jarred, even stunned, the new user with so many possibilities that we are, even now, 20 years later, still trying to figure out the best ways to use it.

A vast number of people and organizations entered the fray. Most efforts failed and disappeared. Many morphed into new efforts and some survived. A few became spectacularly successful and not only created huge wealth for the entrepreneurs but also changed the course of human civilization. The single most important determinant of success or failure of Internet products was and is user experience.

I have the same feeling now in 2018 that I had in 1998 about the promise of the Internet. An everlasting principle has newly surfaced to be of paramount research and clinical importance. It is patient experience, now called Real-World Experience (RWE). Correctly managed, it can become Real-World Evidence (RWE). I call them RWE2. Most patients see a physician only occasionally; for many, as rarely as possible. But patients live with their own health, be it good or ill, 24/7. As many as 90% of medical decisions are made outside the purview of the physician or the physician's records. Twenty years ago, I used to exhort people to "take charge of your health; after all, it is your health." The Internet facilitated that opportunity more than any preceding technology. With biosensors and mobile apps becoming ubiquitous, an even fuller development of that dream is becoming reality. No one in medicine has done more to bring about this transformation than Medscape Editor-in-Chief Eric Topol, especially through his books such as The Creative Destruction of Medicine and The Patient Will See You Now .

The clinical research community, the payers, the pharmas, and the regulators are also acknowledging that 24/7 recognition and reporting of symptoms, observations, and findings will become the key to true personalized or precision medicine. RWE, unfiltered by clinicians, preferably transmitted in real time, will likely increasingly inform clinical research innovation, protocol definition, clinical trials—be they large-scale or with an N of 1—and commercialization of resulting products.

But we must be cautious about excess zeal in pursuing this goal. Humphrey Taylor, chairman of the Harris Poll, once warned about the risk of our creating a nation of cyberchondriacs. Dr Nortin Hadler has spent a career writing books about the "worried well." Nevertheless, we will persist in applying these marvelous new technologies in pursuit of the sweet spots of credible data, information, even truth, to improve life, maximize health, and perhaps even enable more human happiness.

That's my opinion. I am Dr George Lundberg and this is At Large at Medscape.

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