Christine Connolly

Christine Connolly

Associate Director, Data Standard Expert

EMD Serrono

This spotlight was featured in March 2018.

Christine leads the SDS team, which develops SDTM, as well as the Genomics and Biospecimens sub-teams. She also provides subject matter expertise to the CDASH and Controlled Terminology teams.

How long have you been volunteering at CDISC?

I have been volunteering at CDISC since around 2011. I started by working with CDASH teams.

What should someone new to CDISC know about the PGx standard and why was it important to you to lead this team?

Currently, I think it’s less about knowing the standard and more about understanding the data and knowing the landscape. Genetic analysis of clinical and non-clinical samples is becoming standard practice and evolving rapidly. It feels as if there is always something new around the corner. Given this, perhaps more so than for other use cases, collaboration between scientific, data standard, and regulatory staff is needed for standards development and implementation. The standards we develop and use must be robust and flexible enough to accommodate future changes in science and regulation. Whether you are working with the current provisional PGx standard or future iterations, be aware that you will always need both areas of expertise. Involve regulatory authorities early and often to make sure you understand their needs.

As for being a team lead, the potential role of genetics in personalized medicine motivates me. It is especially important for indications, like cancer, where starting with the right treatment can change a person’s life. I like the thought that this team could play even a small part in in this bigger picture. Being a team lead is a way to contribute to something that feels important and rewarding to me.

What are your goals for the PGx team for the next year?

In 2018, we would like to further refine how we use the Pharmacogenomics/Genetics Findings (PF) domain. We are working to develop documented controlled terminology rules for topic variables PFTESTCD (Short Name of Pharmacogenomics Lab Test) and PFTEST (Name of Pharmacogenomics Lab Test) and are focusing on use cases currently submitted to regulatory authorities. We are hoping to model use cases for new controlled terms and share examples with the user community. We are supporting the larger community through review of Therapeutic Area User Guide (TAUG) examples and examples provided by sponsor companies. In late 2018, we hope to begin refining guidance in the current Study Data Tabulation Model Implementation Guide for Pharmacogenomics and Pharmacogenetics (SDTMIG-PGx) v1.0 and will continue this work into 2019.

How did you get into working in clinical research?

Working in clinical research was a bit of a surprise opportunity that presented itself when I was an undergraduate. I didn’t expect it, but once I started working in this space, I loved it.

What is the craziest thing you have ever experienced volunteering with CDISC?

I am not sure I have had a crazy CDISC experience to-date. What have I missed?

What did you want to be when you grew up?

A lawyer, a veterinarian, an art teacher, and an owner of a dusty used book store…  I’m still not sure, but I enjoy what I’m doing now.

Please provide a tip that someone would find helpful in working with CDISC Standards.

Science and regulation dictate what data are needed and data standards facilitate the transfer and communication of data. I think my tip would be to not start with the CDISC Standards. Step back and make sure you truly understand the data you’re working with and where you are in the data life cycle (i.e., planning, collection, tabulation, analysis, reporting). This understanding will guide your use of CDISC Standards; from what standard should be used to how your data should be represented within that standard.