Heather Kopetskie
Associate Vice President, Global Biometrics
Heather Kopetskie
Associate Vice President, Global Biometrics
Heather Kopetskie, Associate Vice President, Global Biometrics has worked at Rho for more than 20 years. Ms. Kopetskie provides leadership and oversight for the biostatistics department and utilizes her experience to guide sponsors on the design and analysis of clinical trials. Her experience spans many therapeutic areas with an emphasis on solid organ and cell transplantation along with rare disease (orphan) products.
At Rho, she has supported both federally funded projects and biotech/pharmaceutical companies. During her tenure she has served as the biostatistical functional lead for the Immune Tolerance Network (ITN) Statistical and Data Coordinating Center and the Clinical Trials in Organ Transplantation (CTOT) Statistical and Clinical Coordinating Center overseeing more than 30 studies in the areas of allergy, immunology, and transplantation.
Ms. Kopetskie earned her master’s degree in Biostatistics from UNC-Chapel Hill.
This is what drives Heather:
“I love working with the team members to find solutions to the unique challenges in clinical trials. Our thinking is constantly being challenged and there is always more to learn. Nothing is more rewarding than seeing the work we do impact patient’s lives.”
Content by Heather Kopetskie
Blog Post
PRO Data in Cancer Clinical Trials
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Patient-Reported Outcome Data Cancer clinical Trials. The guidance illustrates the importance of choosing a PRO vendor that is capable of capturing the recommended content and framework as source data if possible. This will reduce the need for time-consuming and potentially error prone data manipulation in SDTM and ADaM.
Blog Post
CDISC Standards for COAs using Item Response Theory (IRT)
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. The guidance lays out technical specifications to consider when submitting clinical outcome assessment (COA) information that uses Item Response Theory (IRT) in a marketing application.
Blog Post
Use of RWD and RWE to Support Regulatory Decision Making
Real-World Data (RWD) is being increasingly utilized in clinical research to help support drug approvals. The U.S. Food and Drug Administration (FDA) guidance on Considerations for the Use of Real-World Data and Real-World Evidence (RWE) to Support Regulatory Decision-Making for Drug and Biological Products provides thoughtful recommendations on the use of RWE to support approval of a new indication for marketed drugs. This guidance is part of the FDAs Real-World Evidence Program which provides additional guidance for the use of RWE to support regulatory decisions.
Blog Post
4 Benefits of Combining Biometrics Services
Biometrics services (data management, biostatistics, data standards, and statistical programming) can be outsourced together as a unit or individually with different CRO partners. While splitting services up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the data management and biostatistical/programming components for your clinical trial project or program.
Blog Post
Estimands: An insight into the new framework
An estimand framework has been presented by the ICH in November 2019 and the FDA in May 2021 to provide clarity on defining the reported treatment effect. This blog post summarizes the key components to the estimand framework that are covered in the ICH E9 (Revision 1) addendum on estimands and sensitivity analyses in clinical trials, as well as the supporting FDA guidance and ICH training material.
Blog Post
Inspection & Audit Preparation in Decentralized Trials
To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.
Blog Post
Data Integrity Considerations in Decentralized Trials
Collected data from DCTs need to be integrated with other data captured during the course of a clinical trial, and data integrity must be ensured in the absence of source data verification. Two topics will be discussed: how to manage this integration and ensure confidence in the collected data.
Blog Post
Protocol Planning and Design for Quality Decentralized Clinical Trials
Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?
Blog Post
Introduction to Decentralized Clinical Trials
Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. We outline the different approaches to implementing DCTs.