Applied Clinical Trials Digital Edition - June 2011

CRO/SPONSORS : Integrated Drug Safety Archiving in the United Kingdom Language and Culture in Global Trials INFORMATION TECHNOLOGY : Cloud Computing - Pharmacovigilance TRIAL DESIGN : Placebo Effect of Transdermal NSAIDs SITES : IRB Registration SUBJECT RECRUITMENT : Formula for Recruitment Success Also in this issue : e-Submissions Gain Support, Personalized Medicine, iPad Apps for Clinical Trials, R&D Productivity

Articles in this issue

---

Applied Clinical Trials Digital Edition - June 2011

Patient Recruitment Feasibility

Archiving Approach in the UK

Taking Clinical Computing in Hand

Business and News Update June 2011

Getting Personal Over Personalized Medicine

Early Use of Antiretrovirals May Reduce HIV Transmission

Moffitt Cancer Center Chooses Oracle

Current Challenges of Poor R&D

Placebo Effect of Transdermal NSAIDS

Language & Culture in Global Clinical Trials

EMA Seeks to Fine-Tune Official Register

Integrated Drug Safety

Strong Growth in Biopharmaceutical Approvals

FDA Gains Support for e-Submissions Standards

Related Videos

Related Content

Advertisement

August 2nd 2025

Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial

Andy Studna, Senior Editor

In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control tool amid rising insecticide resistance.

August 2nd 2025

ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials

Applied Clinical Trials Editorial Staff

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

August 2nd 2025

Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial

Andy Studna, Senior Editor

In a pre-specified sub-study of the BROADWAY trial, obicetrapib 10 mg significantly reduced plasma p-tau217 levels in patients with ASCVD, including ApoE4 carriers, suggesting dual potential to lower LDL-C and impact Alzheimer’s disease progression.

August 2nd 2025

Unifying Industry to Better Understand GCP Guidance

Andy Studna, Senior Editor

In 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.

August 2nd 2025

Kisunla Slows Cognitive and Functional Decline Over Three Years in Phase III Alzheimer Long-Term Extension Trial

Don Tracy, Associate Editor

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.

August 2nd 2025

Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer

Andy Studna, Senior Editor

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable safety profile and dose-dependent efficacy across endpoints.

Related Content

Advertisement

August 2nd 2025

Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial

Andy Studna, Senior Editor

In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control tool amid rising insecticide resistance.

August 2nd 2025

ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials

Applied Clinical Trials Editorial Staff

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

August 2nd 2025

Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial

Andy Studna, Senior Editor

In a pre-specified sub-study of the BROADWAY trial, obicetrapib 10 mg significantly reduced plasma p-tau217 levels in patients with ASCVD, including ApoE4 carriers, suggesting dual potential to lower LDL-C and impact Alzheimer’s disease progression.

August 2nd 2025

Unifying Industry to Better Understand GCP Guidance

Andy Studna, Senior Editor

In 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.

August 2nd 2025

Kisunla Slows Cognitive and Functional Decline Over Three Years in Phase III Alzheimer Long-Term Extension Trial

Don Tracy, Associate Editor

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.

August 2nd 2025

Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer

Andy Studna, Senior Editor

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable safety profile and dose-dependent efficacy across endpoints.