Enhancing Patient Experience in Clinical Trials: Six Key Insights from Global Patient Surveys

The clinical trial industry is undergoing significant transformation, particularly in the realm of patient experience. As trials become more patient-centric, understanding the diverse perspectives and needs of participants has never been more critical. …

Native Hawaiians/Pacific Islanders Found to be Underrepresented in Clinical Trials

Native Hawaiian and Pacific Islanders had limited, if any, recorded documentation of their participation in clinical trials for 10 drugs with top sales forecasts, according to a recent study published in JAMA Oncology. The study examined 139,062 patients …

Understanding Elafibranor (Iqirvo) for PBC: Insight From New Clinical Trials

In June, elafibranor (Iqirvo) earned accelerated approval from the US Food and Drug Administration (FDA) for the second-line treatment of primary biliary cholangitis (PBC) based on findings from the phase 3 ELATIVE trial evaluating the efficacy and safety …

Brief Overview of PERSEUS, IsKia, and CASSIOPEIA Clinical Trials

Just the Beginning of Improving Diversity Initiatives in Clinical Trials

In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, “Diversity Action Plans in Clinical Trials.” In addition to key takeaways from the article, …

Eligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer.

Trimodality therapy (TMT) is a viable option for muscle-invasive localized bladder cancer, providing an alternative to radical cystectomy in properly selected patients. The approval of novel therapeutics in different stages of bladder cancer treatment has …

Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics

Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while minimizing the impact on non- …

Site QMS-Based Site Monitoring: The New Frontier for Clinical Research Excellence

Twenty years ago, the practice of clinical research at sites was, shall we say, largely artisanal. Study coordinators used black pens to enter data on multi-part paper forms. One-hundred-percent source data verification (SDV) was standard. CROs boasted of …

NextCure Reports Preclinical Data for LNCB74 and Additional Clinical Biomarker Data for NC410 Combo at Society for ...

Preclinical data for LNCB74 highlights its potential as therapeutic for treating multiple solid tumor indications; Investigational New Drug (IND) application filing expected by year-end Additional biomarker data support proposed mechanism of action of …

Black Participation in Food Allergy Trials Can Be Life-Saving

There’s promising new research for food allergies called Food Oral Immunotherapy (FOIT). This treatment allows people to gradually eat foods they’re allergic to, desensitizing them and reducing their reactions. However, a new study shows a major problem: …