Applied Clinical Trials
Industry Standards Research
For years ISR has tracked the dynamics that surround patient and investigator recruitment. Not surprisingly, the industry has challenges associated with recruiting patients into many of its clinical trials. These difficulties aren't confined to just recruiting the patients. The industry has struggled—and continues to struggle—with predicting the recruitment of patients; the process known as feasibility in our industry. For years the industry has relied on poor quality databases, rudimentary questionnaires, and fading technologies to estimate trial recruitment. Even today 36% of the industry relies on fax-based questionnaires to prospective sites to generate recruitment estimates.
But there is reason to be hopeful. In 2009, as part of its Patient and Investigator Recruitment Success research, ISR asked industry representatives how often they rely on various information sources, processes, and technologies as part of their feasibility and trial planning process. Only 14% of respondents indicated they used electronic medical records data to estimate recruitment and 49% indicated an intention to increase this use. It turns out their predictions were correct. In its 2012 update of this research ISR found that 21% of respondents are using EMR data for feasibility estimates. And just as important, 52% indicate that their use of EMR will continue to increase over the next three years.
—Industry Standard Research, www.ISRreports.com.
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.