Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View.

For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et al. in Learn Health Syst 3:e10076, 2019). eSource may provide efficiencies and value; however, eSource adoption is fragmented and slow. Acceleration of eSource adoption is a critical step in modernizing the conduct of clinical trials. The desired future state is one in which all source data, acquired through any context (e.g., healthcare delivery, chronic disease management) and actor (e.g., healthcare professional, patient, caregiver), are completely electronic, adequate in quality, and fully acceptable in clinical trial submissions by regulators worldwide. Achieving this desired future state requires transformative change management to foster adoption and minimize the burden of implementing eSource. Realizing this vision requires collaborative and dedicated efforts from multiple stakeholders, including patients, clinical trial participants, sites, technology vendors, standards organizations, regulators, payers, and sponsors. Stakeholders should align upon guidance to promote data integrity, data privacy, data security, and interoperability. The eSource revolution requires open dialogue, inclusive of shared learnings among stakeholders, to collectively and rapidly advance adoption. Adoption of eSource will optimize clinical research by enabling faster access to research data and more rapid decision-making, increasing clinical trial efficiency. Furthermore, adoption of eSource will improve data integrity by allowing direct data flow from the source to the sponsor's system, with minimal or no human intervention. This paper provides the TransCelerate point of view (POV) and recommendations to achieve the future state vision of complete utilization of eSource data in clinical trials and builds on previous TransCelerate eSource publications.

Responding to a Community's Concern: A Comparison of Breast Cancer Characteristics and Initial Treatment in Three Selected North Carolina Counties.

BACKGROUND A 2007 national report identified North Carolina's Edgecombe County as having among the highest breast cancer incidence and mortality rates nationally, motivating the initiation of a task force and other local efforts to address the problem. The goal of this study is to examine county breast cancer characteristics before and after the report, including whether geographic variation may mask racial disparities in this majority African American community.METHOD With guidance from community partners, breast cancer cases from 2000 to 2012 in Edgecombe, Nash, and Orange Counties (N = 2,641) were obtained from the North Carolina Central Cancer Registry. Bivariate and trend analyses of tumor and treatment characteristics were examined by county and race.RESULTS Women in Edgecombe and Nash Counties were diagnosed with more advanced stage, higher grade tumors. African Americans in Edgecombe and Nash Counties were diagnosed with advanced disease more often than African Americans in Orange County. Average time-to-treatment was well within guideline recommendations. Incidence and mortality rates appear to have declined, with variation in measures of racial differences over time.LIMITATIONS Changes in coding standards across the observation period required reliance on coarse measures that may partially mute useful findings.CONCLUSIONS Racial disparities remain a concern in North Carolina; however, they appear to be less profound than in the 2007 national report. The portentous statistics in the report represent an all-time high, after which some, but not all, measures reflect positive change amidst ongoing local efforts to improve breast cancer knowledge and care.

Peer Connect for African American breast cancer survivors and caregivers: a train-the-trainer approach for peer support.

Racial disparities in breast cancer survivorship are a major concern nationally. How survivors cope with cancer and re-frame their lives is a critical part of survivorship. Community-academic research partnerships may facilitate access to much-needed psychosocial support for African American survivors and caregivers in rural areas, but drivers of successful intervention implementation are not well understood. The purpose of this study was to describe the training and evaluation of Community Coaches and Guides (i.e., peer supporters) using the Peer Connect program for African American breast cancer survivors and caregivers. Community engagement strategies were used to implement the training component of Peer Connect, an evidence-based program grounded in the Diffusion of Innovation Theory utilizing motivational interviewing techniques (MI) and a "train-the-trainer" model. Quantitative and qualitative methods examined implementation outcomes of feasibility, MI fidelity, and acceptability-precursor outcomes that must be achieved before examining intervention impact vis-à-vis changes in support care. Training was feasible to implement and replicable by the trained Community Coaches. Beyond feasibility and replicability, success was modest regarding MI fidelity. Benefits (e.g., serving as role models and having safe sources of support) and lessons learned (e.g., need for additional quality control) were identified as both facilitators and barriers to implementation and as factors that could impact the effectiveness of community-engaged programs to improve survivorship outcomes. Peer Connect, like other programs that employ community-engagement strategies, holds promise to meet the psychosocial support needs of diverse rural cancer survivor populations.