Data trends: A year in review and what will happen next

Here are some trends I perceive:

Research waste​

You are going to be hearing a lot more about research waste.

In May 2017, the World Health Organization’s (WHO) published a joint statement of 21 global funding organizations on public disclosure of results from clinical trials​ affirming, “The prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health​.”

These organizations went on to share their unified plans of action, including developing policies and systems to monitor results, sharing challenges and progress, and making outcomes available to the public.

Clinical trial data bring a wealth of information to facilitate that decision-making … that is, when it’s easy to decipher the results. That’s why I believe in standards and lead an organization that is committed to the global adoption of standards.

Standards reduce research waste by providing common formats for data collection, data sharing, and data analyses, so that data speak the same language to make the most of this valuable information.

Data sharing ​

Data sharing is not a new concept, but it will remain an industry trend... and challenge. There is no doubt that the sharing of data benefits clinical research. Data sharing reduces silos, lets colleagues, competitors and peers learn from hard work and leverage it to find breakthroughs, discover new treatments, and unlock cures.

But what good is data sharing if it cannot be understood? Standardizing data facilitates sharing and comparing of data from different studies and research teams to learn what’s working and what’s not.

At the end of 2016, United States Congress passed the 21 Century Cures Act​, which is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

Specifically, the Act establishes an NIH Innovation Account, allocating your tax dollars to further cutting-edge projects such as the Precision Medicine Initiative, Brain Research through Advancing Innovative Neurotechnologies Initiative, cancer research, and to advance the field of regenerative medicine.

The NIH is starting to require data sharing, but not mandating that it be collected in a standard format. Regulated research in the United States and Japan have made the requirement of CDISC standard data mandatory for submission.

Standards have to be at the center of this transformation for the NIH and all academic research for data sharing to be effective. Data Standards are a multiplier in their effectiveness. If the data being shared is not in a standard format, we are losing time and money, and patients cannot wait.

Personal device-derived data​

Devices (smartphones, wearables, etc.) are quite capable of collecting data about your health: diagnostics as well as real-world data about your physical activity, sleep, and diet. 2018 will see a rise in the quantity—though not necessarily quality—of personal-device-derived data.

Sam Volchenboum, MD, PhD, the director of the Center for Research Informatics at the University of Chicago, a board-certified pediatric hematologist and oncologist and a co-founder of Litmus Health​ was quoted in an article in Tech Crunch​ on the next steps that need to happen for devices.

He stated, “If we want better devices, we must do a better job of telling manufacturers what kinds of measurements and outputs we need. It is critical that the research community develop, promote and use standards for data collection, storage and reporting that can be easily understood and adopted by everyone, including non-experts​.”  

CDISC is charged to support new research and so is preparing the organization for changes in technologies and the expanding sources of data that can potentially flow into the clinical data universe. We need to take a new look at how variables and data elements among standards harmonize so that we can be fully integrated into enterprise-level automations. 

We also need to provide our users with standardized solutions and better equip vendors and technology companies to build solutions based on the CDISC standards. Additionally, our development on a modernized CDISC SHARE metadata repository will give us the ability to update standards at the content level, and we have begun planning for this updated set of tools.

Dr. Volchenboum spoke at CDISC’s 2017 International Interchange conference on personal-device derived data, the opportunities, and the pitfalls. I believe we need more open dialogue among researchers and personal-device developers. My guess is that the general public would be quite open and supportive of their personal health data from these devices informing research. We need to honor this commitment of data with commensurate systems and structures to support its effective utilization in research.

As trends come and go, each time you advocate, fund or conduct research, you should ensure that the data are collected, tabulated, and analyzed in CDISC format so that the data can be shared and compared, eliminating the silos of research. CDISC remains steadfast in our mission of developing global standards that foster smarter research to unlock cures.