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This framework marks the agency’s first official recommendation on the use of AI in drug development.

In this video interview, Sujay Jadhav, CEO of Verana Health, discusses how the use of unstructured data can help improve clinical research in 2025.

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.

Intrathecal onasemnogene abeparvovec (OAV101 IT) demonstrated an increase from baseline in Hammersmith Functional Motor Scale – Expanded total score in children and young adults with SMA.

This year’s submissions highlight initiatives around accelerating enrollment, personalizing recruitment, increasing diversity, and more.

Study finds that existing patient-reported outcome (PRO) measures fail to fully capture health-related quality-of-life for some conditions, highlighting the need for a novel, disease-specific PRO to better assess treatment efficacy and improve patient care in clinical trials.

Phase III trial shows the combination of brexpiprazole plus sertraline significantly improved the symptoms of post-traumatic stress disorder compared to sertraline plus placebo, with a tolerable safety profile and low discontinuation rates.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses some of the key ways that different trial sponsors may need support in meeting diversity expectations.

The complexities behind these translations require specialized personnel who are nuanced in both medical cultures.

Check out our top five most engaged social media posts from the year 2024.

Applied Clinical Trials sat down on-site with many KOLs at some of industry's largest gatherings in 2024 including SCOPE, DIA, and DPHARM.

Support from these partners can aid drug and medical device developers in keeping up with the evolving regulatory landscape.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, highlights the use of real-world data in setting population goals.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses the importance of goal setting in the context of FDA’s latest Diversity Action Plan guidance.

How a deeper review of site budget and payment processes and technology is driving meaningful change in the industry.

Advancements in this field have the potential to transform cancer care and improve quality of life for patients.

Recent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.

Prasinezumab did not achieve statistical significance for its primary endpoint in the Phase IIb PADOVA trial for early-stage Parkinson's disease, but showed potential clinical efficacy with positive trends in motor progression and secondary outcomes.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), looks forward and shares her thoughts on future trends with clinical technology.

In patients with type 2 diabetic nephropathy, bremelanotide demonstrated efficacy in reducing urine protein to creatinine ratio and improving or stabilizing estimated glomerular filtration rate.

Depemokimab, an ultra-long-acting anti–IL-5 biologic therapy, significantly reduced annual asthma exacerbations in patients with severe eosinophilic asthma while maintaining a favorable safety profile, offering the potential for improved patient quality of life with reduced dosing frequency.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), highlights how DTRA is working with sites and sponsors to gauge the feasibility of site-validated technology use.

Duvakitug, a monoclonal antibody, demonstrated clinical remission and endoscopic response in the study, meeting its primary endpoints.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discusses several initiatives DTRA is working on to keep sites in-the-know on DCT elements included in study protocols.

Results from the EMBER-3 trial show imlunestrant, both as monotherapy and in combination with Verzenio (abemaciclib), significantly improved progression-free survival in ESR1-mutated ER-positive, HER2-negative advanced breast cancer.

Strategies for sponsors to utilize technology in reaching diverse patient populations.

Data from the OlympiA Phase III trial show Lynparza (olaparib) significantly improved the risk of death, invasive disease-free survival, and distant disease-free survival over six years in patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), highlights challenges with technology adoption including how sites may be asked to work with a variety of different providers.

Balancing these tools with operational efficiencies can aid CROs in meeting the evolving needs of sponsors.

Results from the DREAMM-7 Phase III trial demonstrated that Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone significantly improved overall survival, progression-free survival, and treatment response in relapsed or refractory multiple myeloma compared to a daratumumab-based regimen.