Conducting Clinical Trials in a Blizzard

For much of history, medical care and research have been conducted in a clinical setting with constant supervision from authority figures in white lab coats. The requirement of being physically present at a hospital or clinic to receive care was self-evident. Then came the concept of telemedicine. Until the advent of the Internet, the notion of telemedicine was simply science fiction and was impractical for the average person to use. So what exactly is telemedicine? Telemedicine is the idea that medical care could be accessed virtually by any patient with a connection to the outside world. This concept ranges from real surgeries that are done by surgeons in another state to remote psychiatric counseling. This implies that even in an historical blizzard which paralyzes much of the Northeast, medical care can still be provided to residents in the confines of their home — as long as there is still access to a connected computer.

In our current technological revolution, mobility is now the crucible of all innovation. Instead of being around a computer to receive virtual services, a person just needs to be around their smart phone. More than 2 billion people in the world have access to a smart phone, which has the far more computing power than a 1960’s guidance computer that was used by NASA on the Apollo missions. In 2020, more than 6.1 billion people will have a smart phone — that is a lot of data points! As many people already know, this revolution has created large markets that sell apps and virtual services just for smartphones. The utility for most of these apps and services can be debated. But one thing is for sure, technological capacity of the smartphone has now reached a point where it can do more than just send Instagram pictures.

As mentioned in my last week note, there is a huge potential to improve research through gathering information of a large network of people (i.e. Big Data). Researchers are already using social media to recruit patients and improve the diversity of research subjects in a clinical trial. Even more so, mobile technology has pushed the boundaries of connectivity to a new level. If you imagine how long an average person is around smart phones, you’ll realize that it is very possible for a person to be monitored consistently. With the immense capabilities of sensing and sending signals, it is possible for smartphones to become data collectors. Even in conventional studies where bloodwork needs to be completed, smartphones now have the ability to analyze blood samples. There have already been numerous studies that harness this tecnology. The medical community has started to embrace mobile health care and electronic data capture (EDC) technologies, especially in developing countries where resources are scrace. There is no doubt that this will be the trend for clinical research in the near future. Besides smartphones, there are now other commercial health trackers that range from the iWatch to Fitbit wristbands. Although these gadgets are simply used for exercise and basic health monitoring, their purpose can be extended to include clinical data capture. Specialization in commercial mobile health technology makes it possible for cheap solutions to become an alternative to traditionally expensive medical devices. This will also pave the way to developing comprehensive diagnostics to detect new biomarkers that facilitate precision medicine.

Now what do we do with all this data? Medidata, a company that offers cloud-based solutions for clinical research in life sciences, has already started to collaborate with Garmin, the same people that make Global Positioning Systems (GPS) for cars. Medidata has already built the infrastructure that supports this vast quantity of data. Furthermore, platforms and infrastructure to conduct these types of clinical trials are now being funded by NIH in order to support the vision of mobile clinical trials. As EHR infrastructure matures to a point where data interchange between different health systems become very fluid, it would enable mobile health care and telemedicine to become easier for practitioners and patients.

We are getting closer to conducting clinical trials in a blizzard. But there is still the issue of privacy and potential exploitations. The public currently has some trust issues with technology companies, and there is definitely some vagueness over the ownership of an individual’s data. People’s suspicions of technology company’s intentions and their ability to handle sensitive data are understandable, especially given the amount of malicious attacks on health care IT. So as we enter this brave new world of mobile clinical trials, there are many issues that still needs to be addressed. Using the system perspective, we must understand the shift of power and influence of the clinical trials system. Which stakeholder will be the one to take the lead on this vision? Will the Age of Data enable technology companies to have large influence over the pharmaceutical companies? We must also identify whether there are now new ethical quandaries related with the ownership of data. Does the clinical trials data belong to the technology companies now? And if so, do they have moral obligations to protect it? Guiding a dynamic system to adapt to these changes will require extraordinary insight from multiple perspectives.

Even though the technology has come a long way, the process of clinical research has not progressed at all. The vast majority of clinical trials are still carried out in physical research sites that require large amount of resources to operate. As with any advancement in history, policy and regulations must play catch-up to innovation. Resistance to change is an inherent feature of any industry, and finding the path with least-resistance is tricky. As we have seen so far, there exist whole industries (see CROs) that are simply arbitragers benefiting from these Luddite attitudes of the old clinical world. I am not disparaging these stakeholders since they are simply practicing the Art of Business. However, it is possible to reorient this system of capital gains to serve as an instrument for technological progress by highlighting the capabilities of common technological tools such as smart phones, much like Uber did. In a world where pharmaceutical pricing is governed by oligopolistic markets, democratizing medicine to a point where you can conduct clinical trials in a blizzard will be a disruptive solution.

Gary Lin