News

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.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), touches on the adoption of DCT elements and how it can affect study team members.

With the increasing use of artificial intelligence and machine learning in medicine development, what role will they play in the clinical trial space moving forward?

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), shares her most important takeaways from the event including how industry is becoming more and more ready to adopt decentralized elements.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discusses how some stakeholders view DCTs only as fully remote trials.

Phase III CARTITUDE-4 trial shows Carvykti significantly improves minimal residual disease negativity rates, progression-free survival, and overall survival compared to standard therapies for patients with relapsed or refractory multiple myeloma, especially when used earlier in treatment.

In this video interview, Mark Melton, vice president of biospecimen data and operations, Slope, talks secure data transfer and risk mitigation.

Interim results from the lead-in cohort showed some patients who received LP-300 alongside chemotherapy experienced an average tumor size reduction of 51%.

The Phase III AALL1731 trial demonstrated that adding Blincyto (blinatumomab) to chemotherapy significantly improved three-year disease-free survival in pediatric patients with standard-risk B-cell acute lymphoblastic leukemia.

In this video interview, Mark Melton, vice president of biospecimen data and operations, Slope, touches on the challenges with hand-written data collection and how they can be addressed with AI.

Palmese, executive director, site relationships and DCT solutions, discusses the practice of incorporating decentralized elements in a study rather than planning a decentralized trial from the start.