Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products.

Background: Significant advancements have been made in the field of cellular therapy as anti-cancer treatments, with the approval of chimeric antigen receptor (CAR)-T cell therapies and the development of other genetically engineered cellular therapies. CAR-T cell therapies have demonstrated remarkable clinical outcomes in various hematological malignancies, establishing their potential to change the current cancer treatment paradigm. Due to the increasing importance of genetically engineered cellular therapies in the oncology treatment landscape, implementing strategies to expedite development and evidence generation for the next generation of cellular therapy products can have a positive impact on patients.

Weight change and mental health status in a behavioral weight loss trial.

Background: Obesity, depression, and anxiety often co-occur, but research on weight change and mental health status is limited. This analysis examined how the mental component score (MCS-12) from the Short Form health survey changed over 24 months in weight loss trial participants with vs. without treatment seeking for affective symptoms (TxASx) and by weight change quintiles.

A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study.

Objective: To evaluate the effectiveness of two technology-enhanced interventions for diabetes prevention among adults at risk for developing diabetes in a primary care setting.

Methods: The DiaBEAT-it study employed a hybrid 2-group preference (Choice) and 3-group randomized controlled (RCT) design. This paper presents weight related primary outcomes of the RCT arm.

Human papillomavirus vaccine beliefs and practice characteristics in rural and urban adolescent care providers.

Background: The human papillomavirus (HPV) vaccine is recommended for all adolescents age 11-12 years. HPV vaccine coverage remains suboptimal in the United States though, particularly in rural areas. We surveyed adolescent immunization providers in two Midwestern states to assess rural vs.

Effects of a Digital Diabetes Prevention Program: An RCT.

Introduction: In light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control.

Study Design: This was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up.

Setting/participants: A total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices.