Applied Clinical Trials Digital Edition - February 2011

INFORMATION TECHNOLOGY : A Risk-Based Approach for Computer Systems Validation SITES : Trial Monitoring - Source Document Verification REGULATORY : FDA's Guidance on Patient-Reported Outcomes ALSO IN THIS ISSUE : FDA's Oversight Capabilities Increased, Influenza Warning Issued, Cloud Computing: A Reality?, Guidance Says Focus on the Patient

Articles in this issue

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Applied Clinical Trials Digital Edition - February 2011

Applied Clinical Trials Digital Edition - February 2011, Supplement

Rates Increase Abroad Due to High Demand

Hispanics Remain Minority in Clinical Trials

State Cash Fuels Growth in England

Act Cover

Biosimilars in the US & EU Regulatory Pathways

The FDA's Guidance on PRO

H1N1 Influenza: Not to be Sneezed at

Cardiovascular Drug Trial Discontinued

New Approach to System Validation

act cover

The Patient Matters: Thanks FDA

Business and News Update February 2011

Targeting Source Document Verification

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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.

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

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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.

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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.

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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.

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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.

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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.

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August 3rd 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 3rd 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 3rd 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 3rd 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 3rd 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 3rd 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.