Heather Kopetskie
Senior Director, Biostatistics
Heather Kopetskie
Senior Director, Biostatistics
Heather Kopetskie, Senior Director of Biostatistics, has worked at Rho for over 14 years. Ms. Kopetskie has experience across Phase 1-4 and observational studies in a variety of therapeutic areas. Ms. Kopetskie is skilled in collaborating on protocol development, writing detailed statistical analysis plans, supporting DSMB meetings, analysis of clinical data, writing and reviewing statistical reports and statistical sections of clinical study reports, and collaborating in manuscript development. She also supervises and coordinates daily activities of other statisticians and programmers. Her primary research experience is in transplantation (over 10 years of experience), infectious disease (MRSA, VRE, and HIV), Hepatitis C, central nervous system (Multiple Sclerosis), and autoimmune diseases (Lupus and Type I Diabetes).
Content by Heather Kopetskie
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.
Blog Post
Statistical Guidance for COVID-19 Impacted Trials
Clinical trials conducted during the COVID-19 pandemic have been impacted by public health measures to control the virus. In June, the FDA released a guidance on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. We summarized the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.
Blog Post
Site Investigator vs. Sponsor SAE Causality: Are they different?
Causality assessments may differ between the site investigator and sponsor. It is important to understand the difference in assessments to ensure proper reporting and conduct through a trial. To better understand how to handle these situations it’s important to understand the differences.