The Litmus Papers
Published in

The Litmus Papers

Trial by Data Podcast: Creating the Manhattan Project for Clinical Research

Featuring Dr. Becky Kush of CDISC and Catalysis Research and Dr. Sam Volchenboum

This week we welcome Dr. Becky Kush to Trial by Data to discuss clinical collaboration and data management in the age of COVID, global approaches to standards, and lessons from founding CDISC.

Dr. Kush is President of Catalysis Research, as well as the founder of the Clinical Data Interchange Standards Consortium (CDISC).

At CDISC, Dr. Kush spent 20 years leading the development of global clinical research data standards to streamline clinical research. While there, she served as the president and CEO and had an integral role in the development of methods and processes to link research and health care.

In her current role at Catalysis Research, Becky catalyzes initiatives to streamline clinical research and accelerate learning from research to inform health decisions.

She is currently working with Elligo Health Research, the International Academic Research Organization Council (through the Translational Research Center for Innovation in Japan) and the Learning Health Community.

Throughout her career, Kush has also worked for the U.S. National Institutes of Health, academia, a global contract research organization and pharmaceutical companies in the United States and Japan.

You can find her on LinkedIn here.

You can listen to the full episode, and others, on iTunes, SoundCloud, and Stitcher. We appreciate your tuning in.

Listen and subscribe here: Trial by Data, presented by Litmus Health.

Each episode, we pull out some of the key themes of the conversation for our listeners.

Here are the highlights from our conversation with Dr. Kush:

Clinical research needs its Manhattan project. There are several moonshoots of real consequence going on right now in the clinical trial space that feel ripe for a Manhattan project moment. This idea was first proposed by Seth Berkley of Gavi, and it’s an opinion Dr. Kush shares. However, Dr. Kush points out that the Manhattan project was run by the US Government, and it was top secret. And what we really need in clinical trials is a global effort where we’re sharing data. For a project like this to work today, it would need to be collaborative across countries and truly transparent. Fortunately, COVID may have helped shift the culture this way.


We need a systems approach to data management for COVID. Especially with COVID, we can’t work off of point solutions and point data collections. Instead, we need data standards that can support a systems approach. CDISC is heading up this effort by leveraging all of the work that’s been done on Ebola standards, vaccine standards, and virology. Through this approach, they have been able to successfully develop and share a COVD-19 data standard in six weeks, which was previously unheard of.


We are finally realizing the vision of the 21st Century Cures Act. The FDA has been pushing decentralized clinical trials since this legislation. However, until COVID, we haven’t seen widespread adoption. Both Dr. Kush and Dr. Volchenboum validated that there is now a greater acceptance for and from companies to allow remote enrollment, or to not require the same frequency of in-person clinician visits. This is going to have a lot of benefits, including potentially enabling a greater diversity in clinical trials, as well as encouraging the continued adoption of wearables in trials.


The FDA is seriously looking at FIHR. FIHR (Fast Healthcare Interoperability Resources) has come out of the healthcare industry as a potential alternative to the current system in which every EHR collects data differently. However, while FIHR looks promising in this regard, it still doesn’t accommodate tables and analysis datasets. Until it can accommodate these other data requirements, it shouldn’t be considered a silver bullet.

The PMDA and the FDA have learned a lot from each other. The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has very similar requirements around data for clinical research as the FDA. However, PMDA has a system called SS-MIX (Standard Structured Medical Information eXchange), which enables the organization to take data from EHRs in a common standard format. Given that EHRs are still an incredible headache for the FDA when it comes to standardization, it might be worthwhile to take a page out of Japan’s book.

In regulated industries, people are afraid of the regulators — and they shouldn’t be. While many companies are nervous about incorporating new technologies because of concern over how the FDA will react, the FDA has long encouraged decentralized clinical trials and the usage of real world data. Personally, Dr. Kush spoke to the fact that, since the founding of CDISC, the FDA served as a liaison on the organization’s committees.

Part of what is motivating the FDA here is that they have been pushed by PDUFA to do faster reviews. However, in order to be able to achieve this, the FDA needs the data to come in in a standard format.


Trial by Data, presented by Litmus Health, is a podcast exploring the data-driven technologies and strategies shaping the future of clinical trials. We cover the most pressing issues and questions facing researchers and clinicians today, in an ever-changing landscape. Listen in as we interview leaders and innovators in the field who are at the forefront of developing and using these data-driven approaches.



Get the Medium app

A button that says 'Download on the App Store', and if clicked it will lead you to the iOS App store
A button that says 'Get it on, Google Play', and if clicked it will lead you to the Google Play store
Litmus Health

Litmus Health

Litmus is a clinical data science platform focused on health-related quality of life.