Related Experiment Video

Updated: Aug 19, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

10.7K

The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial

Evelynne S Fulda1, Carl J Fichtenbaum2, Emma M Kileel1

  • 1Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.

Contemporary Clinical Trials
|December 3, 2022
PubMed

Insights

A comprehensive approach to evaluating clinical research site performance in the REPRIEVE HIV trial ensured steady participant retention and data quality. This methodology enhances operational success for large-scale clinical trials.

Area of Science:

  • Cardiology
  • Infectious Diseases
  • Clinical Trial Management

Background:

  • The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a global multicenter trial assessing statin efficacy for cardiovascular event prevention in people with HIV.
  • Ensuring trial integrity and data quality necessitates novel methods for evaluating clinical research site (CRS) performance.

Purpose of the Study:

  • To describe and evaluate a comprehensive, multidimensional methodology for assessing CRS performance within the REPRIEVE trial.
  • To assess the impact of this methodology on participant retention, data management, and specimen management.

Main Methods:

  • A robust system for CRS evaluation and communication was developed by the REPRIEVE Data and Clinical Coordinating Centers.
  • The system focused on identifying performance issues, providing real-time support, and recommending process improvements.
  • Evaluation metrics included participant retention, data, and specimen management from 2019 to 2022, based on pre-defined metrics, regular reviews, and bidirectional communication.

Main Results:

  • Participant retention, data management, and specimen management metrics remained stable throughout the three-year evaluation period.
  • Performance metrics showed variations by country of enrollment.
  • Targeted communication strategies effectively improved specific performance metrics.

Conclusions:

  • A comprehensive approach to evaluating CRS performance is vital for maintaining trial integrity and achieving key trial objectives.
  • This methodology effectively supports data and specimen management while enhancing participant retention.
  • The demonstrated approach can serve as a model for optimizing the operational success and scientific rigor of future large-scale clinical trials.
Abstract

Keywords:
Clinical trial managementData managementParticipant retentionSite performance

More Related Videos

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time06:05

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

1.3K
A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development07:02

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Published on: February 11, 2019

9.9K

Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
6.9K
Longitudinal Research02:20

Longitudinal Research

Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
12.1K
Longitudinal Studies01:26

Longitudinal Studies

Longitudinal studies are also widely used in other medical and social science fields. For instance, in cardiovascular research, they can monitor patients' health over decades to identify risk factors for heart disease, such as high cholesterol or smoking, and evaluate the long-term effectiveness of preventive measures. Similarly, in mental health studies, researchers might follow individuals from adolescence into adulthood to understand the development and progression of conditions like...
205
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
157
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.1K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
345