Assessing the net financial benefits of employing digital endpoints in clinical trials.

In the last few decades, developers of new drugs, biologics, and devices have increasingly leveraged digital health technologies (DHTs) to assess clinical trial digital endpoints. To our knowledge, a comprehensive assessment of the financial net benefits of digital endpoints in clinical trials has not been conducted. We obtained data from the Digital Medicine Society (DiMe) Library of Digital Endpoints and the US clinical trials registry, ClinicalTrials.

Benchmarking Site Activation and Patient Enrollment.

Clinical trial conduct poses numerous challenges, many pertaining to patient recruitment. The primary objectives of this study were to update benchmarks on site activation and patient enrollment gathered in previous Tufts CSDD studies and examine current usage of recruitment and retention tactics. The data collection focused on site activation and patient enrollment metrics used for studies.

Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials.

Background: Risk-based monitoring (RBM) and risk-based quality management (RBQM) offer a compelling approach to increase efficiency, speed and quality in clinical trials by prioritizing and mitigating risks related to essential safety and efficacy data. Since 2013, the FDA and EMA have encouraged the use of RBM/RBQM, however adoption has been slow with limited understanding of the barriers to adoption.

Methods: The Tufts Center for the Study of Drug Development conducted an online survey among pharmaceutical, biotechnology, and contract research organizations and gathered 206 responses on 32 distinct RBQM practices.

Is Your Organization's Remote Work Strategy "Working"? Exploring the Impact of Employees' Attitudes Toward Flexible Work Arrangements on Inclusion and Turnover Intention.

The Covid-19 pandemic drastically changed the way people work. This was no exception in the drug development industry, which like other industries has been grappling with the challenge of how to manage the transition back to the office while ensuring that people feel included. To understand what strategies organizations in the drug development industry are adopting and examine their impact on the employee experience, Tufts Center for the Study of Drug Development launched a survey that quantified the different strategies and their effect on work outcomes, including burnout, inclusion, and turnover.