Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Background: Patient registries are organized systems that use observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Data collected in registries often coincide with data that could support clinical trials. Integrating clinical trials within registries to create registry-embedded clinical trials offers opportunities to reduce duplicative data collection, identify and recruit patients more efficiently, decrease time to database lock, accelerate time to regulatory decision-making, and reduce clinical trial costs.

EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM.

Objective: Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days.

Methods: This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency).

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.

Importance: Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited.

Objectives: To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life.

Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products.

Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations.

Background: Computer-aided data validation enhanced by centralized monitoring algorithms is a more powerful tool for data cleaning compared to manual source document verification (SDV). This fact led to the growing popularity of risk-based monitoring (RBM) coupled with reduced SDV and centralized statistical surveillance. Since RBM models are new and immature, there is a lack of consensus on practical implementation.

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality.

Background: Data quality within the clinical research enterprise can be defined as the absence of errors that matter and whether the data are fit for purpose. This concept, proposed by the Clinical Trials Transformation Initiative, resulted from a culmination of collaboration with industry, academia, patient advocates, and regulators, and it emphasizes the presence of a hierarchy of error types, resulting in a more efficient and modern data-cleaning paradigm. While source document verification (SDV) is commonly used as a quality control method in clinical research, it is disproportionately expensive and often leads to questionable benefits.

Monitoring the quality of conduct of clinical trials: a survey of current practices.

Background: There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings.

Purpose: The purpose of this project was to describe current methods of monitoring clinical trials and to explore the rationale for the use of those methods.

Methods: An electronic survey of known monitoring practices was developed and sent to over 200 organizations involved in conducting clinical research.

Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database.

Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to access the impact of the changes. To accomblish the aim, Target e*CRF was used as the EDC tool for a multinational, dose-finding, multicenter, double-blind, randomized, parallel, placebo-controlled trial to investigate efficacy and safety of a new treatment in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.