Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
Journals - Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
News - Applied Clinical Trials
An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.
Spotlight on Open-Label Extension Studies - Applied Clinical Trials
Jul 1, 2006 · Open-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study …
Estimand Framework: What it is and Why You Need it
Feb 27, 2020 · According to section A.6 of the ICH guidance 1, the clinical trial protocol should very clearly specify a primary estimand that addresses the primary study objective.Estimands for secondary trial objectives that support regulatory approval …
CTMS: What You Should Know - Applied Clinical Trials
Mar 18, 2016 · ** : Bespoke Solutions based on extending CRM solutions OR Platform (PaaS) Summary. The myriad scientific, regulatory, and marketplace changes taking place in clinical trial management are creating a pressing need for innovative solutions that can span and integrate multiple, geographically dispersed trial partners and sites.
Applied Clinical Trials Online
January 16th 2025. An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.
WCG Announces the Formation of WCG IRB and Launch of WCG …
Oct 12, 2020 · WCG has announced the unification of its five IRBs—Western IRB (WIRB), Copernicus Group IRB (CGIRB), Midlands IRB (MLIRB), New England IRB (NEIRB), and Aspire IRB—into the single WCG IRB brand.
Don Tracy, Associate Editor - Applied Clinical Trials
In an interview with Applied Clinical Trials Associate Editor Don Tracy, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial.
Four-Steps to Accelerate Study Start-up Cycles - Applied Clinical …
Mar 5, 2024 · Completing study start-up in clinical trials takes determination, coordination, and continuous process improvement. The average time from site identification to study start-up completion is nearly eight months. 1 This reflects challenges as teams continue to work in silos, follow complex workflows, and manage international regulations. A top 20 biopharma found that applying a four-step ...