Ryan Bailey, MA is a Senior Clinical Researcher at Rho.  He has over 10 years of experience conducting multicenter asthma research studies, including the Inner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project. Ryan also coordinates Rho’s Center for Applied Data Visualization, which develops novel data visualizations and statistical graphics for use in clinical trials.

Last week, PhUSE hosted its first ever US Connect conference in Raleigh, NC. Founded in Europe in 2004, the independent, non-profit Pharmaceutical Users Software Exchange has been a rapidly growing presence and influence in the field of clinical data science. While PhUSE routinely holds smaller events in the US, including their popular Computational Science Symposia and Single Day Events, this was the first time they had held a large multi-day conference with multiple work streams outside of Europe. The three-day event attracted over 580 data scientists, biostatisticians, statistical programmers, and IT professionals from across the US and around the world to focus on the theme of “Transformative Current and Emerging Best Practices.”

After three days immersed in data science, we wanted to provide a round-up of some of the main themes of the conference and trends for our industry.

Emerging Technologies are already Redefining our Industry

It can be hard to distinguish hype from reality when it comes to emerging technologies like big data, artificial intelligence, machine learning, and blockchain.  Those buzzwords made their way into many presentations throughout the conference, but there was more substance than I expected.  It is clear that many players in our industry (FDA included) are actively exploring ways to scale up their capabilities to wrangle massive data sets, rely on machines to automate long-standing data processing, formatting, and cleaning processes, and use distributed database technologies like blockchain to keep data secure, private, and personalized.  These technologies are not just reshaping other sectors like finance, retail, and transportation; they are well on their way to disrupting and radically changing aspects of clinical research.

The FDA is Leading the Way

Our industry has gotten a reputation for being slow to evolve, and we sometimes use the FDA as our scapegoat. Regulations take a long time to develop, formalize, and finalize, and we tend to be reluctant to move faster than regulations. However, for those that think the FDA is lagging behind in technological innovation and data science, US Connect was an eye opener. With 30 delegates at the conference and 16 presentations, the agency had a strong and highly visible presence.

Moreover, the presentations by the FDA were often the most innovative and forward-thinking. Agency presenters provided insight into how the offices of Computational Science and Biomedical Informatics are applying data science to aid in reviewing submissions for data integrity and quality, detecting data and analysis errors, and setting thresholds for technical rejection of study data. In one presentation, the FDA demonstrated its Real-time Application for Portable Interactive Devices (RAPID) to show how the agency is able to track key safety and outcomes data in real time amid the often chaotic and frantic environment of a viral outbreak. RAPID is an impressive feat of technical engineering, managing to acquire massive amounts of unstructured symptom data from multiple device types in real time, process them in the cloud, and perform powerful analytics for “rapid” decision making. It is the type of ambitious technically advanced project you expect to see coming out of Silicon Valley, not Silver Spring, MD.

It was clear that the FDA is striving to be at the forefront of bioinformatics and data science, and in turn, they are raising expectations for everyone else in the industry.

The Future of Development is “Multi-lingual”

A common theme through all the tracks is the need to evolve beyond narrowly focused specialization in our jobs. Whereas 10-15 years ago, developing deep expertise in one functional area or one tool was a good way to distinguish yourself as a leader and bring key value to your organization, a similar approach may hinder your career in the evolving clinical research space. Instead, many presenters advocated that the data scientist of the future specialize in a few different tools and have broad domain knowledge. As keynote speaker Ian Khan put it, we need to find a way to be both specialists and generalists at the same time. Nowhere was this more prevalent than in discussions around which programming languages will dominate our industry in the years to come.

While SAS remains the go-to tool for stats programming and biostatistics, the general consensus is that knowing SAS alone will not be adequate in years to come. The prevailing languages getting the most attention for data science are R and Python. While we heard plenty of debate about which one will emerge as the more prominent, it was agreed that the ideal scenario would be to know at least one, R or Python, in addition to SAS.

We Need to Break Down Silos and Improve our Teams

On a similar note, many presenters advocated for rethinking our traditional siloed approach to functional teams. As one vice president of a major Pharma company put it, “we have too much separation in our work – the knowledge is here, but there’s no crosstalk.” Rather than passing deliverables between distinct departments with minimal communication, clinical data science requires taking a collaborative multi-functional approach. The problems we face can no longer be parsed out and solved in isolation. As a multi-discipline field, data science necessarily requires getting diverse stakeholders in the room and working on problems together.

As for how to achieve this collaboration, Dr. Michael Rappa delivered an excellent plenary session on how to operate highly productive data science teams based on his experience directing the Institute for Advanced Analytics at North Carolina State University. His advice bucks the traditional notion that you solve a problem by selecting the most experienced subject matter experts and putting them in a room together. Instead, he demonstrated how artfully crafted teams that value leadership skills and motivation over expertise alone can achieve incredibly sophisticated and innovative output.

Change Management is an Essential Need

Finally, multiple sessions addressed the growing need for change management skills. As the aforementioned emerging technologies force us to acquire new knowledge and skills and adapt to a changing landscape, employees will need help to deftly navigate change. When asked what skills are most important for managers to develop, a VP from a large drug manufacturer put it succinctly, “our leaders need to get really good at change management.”

In summary, PhUSE US Connect is helping our industry look to the future, especially when it comes to clinical data science, but the future may be closer than we think. Data science is not merely an analytical discipline to be incorporated into our existing work; it is going to fundamentally alter how we operate and what we achieve in our trials. The question for industry is if we’re paying attention and pushing ourselves to evolve in step to meet those new demands.