Clinical Trials featured content on bio

1. Quantitative Measurements Of p95 Protein Expression In Tumors From Patients With Metastatic Breast Cancer Treated With Trastuzumab 1/2/2014

   Background: Expression of p95 in HER2-positive breast cancer is potentially a major determinant of trastuzumab resistance because p95 lacks the trastuzumab binding site while retaining kinase activity. Previously, an optimal clinical cutoff for a continuous measurement of p95 expression was defined in a training set of trastuzumabtreated MBC patients (Clin Cancer Res, 16:4226, 2010).

2. Clinical And Analytical Performance Of Non-Small Cell Lung Cancer Biomarkers 1/2/2014

   A variety of biomarkers are currently used to help guide treatment decisions for patients with non-small cell lung cancer (NSCLC). These include mutation analysis for the EGFR and KRAS genes, along with gene rearrangement analysis for the ALK and ROS1 loci. In this study we have evaluated the clinical and analytical performance features of these assays in a series of formalin-fixed paraffin-embedded (FFPE) tissue samples.

3. Flow Cytometry For The Pharmaceutical Industry In A Central Lab – Clinical Trials Setting: Specific Challenges And Solutions 1/2/2014

   With the exception of some simple generic assays (such as lymphocyte T/B/NK Immunophenotyping, CD4 counting or progenitor counting) the implementation of pharma-client tailored flow cytometry assays within a multisite, multiplatform environment (central lab / clinical trials setting) in global longitudinal studies involves specific challenges that necessitate special processes and quality control procedures. We already addressed these well before flow cytometric assays became generally adopted in the clinical trials field.

4. Analysis Of Gene Expression Profiling Of Formalin-Fixed And Paraffin-Embedded Tumor Tissues From Preclinical Models And Patient Samples In Early Phase Clinical Trials 1/2/2014

   The objective of this study was to identify gene expression biomarkers that are potentially predictive for birinapant response. Birinapant is a novel small molecule that mimics endogenous Smac (Second mitochondrial-derived activator of caspases), by activating the programmed cell death pathways that are dysregulated in cancer cells.

5. Acquisition Expands Phase I Capabilities 12/3/2013

   Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

   With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States. 

6. Collaboration Seeks To Simplify Investigator Engagement 11/6/2013

   Anyone involved in clinical work knows investigator engagement is not an easy task. Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.

   Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.

7. Global Trials Roundtable – Controlling Cost And Mitigating Risk 10/24/2013

   The current economy, patent expirations of multibillion dollar drugs, and the rising cost of clinical trials (and drug development in general) has many in the pharma industry placing an increased emphasis on controlling costs. Companies must do this while continuing to take more trials to a global market and seeking out more strategic relationships with clinical partners.

   To gain a better understanding of the current trends in clinical outsourcing, and what can be done to control the cost of trials, Clinical Leader conducted a roundtable discussion with executives from several CROs. The panel included: Paula Brown Stafford, president of clinical development at Quintiles; Wendel Barr, CEO of SynteractHCR, James D. Esinhart, CEO of Chiltern, Wanda Dobrzanski Nisiewicz, VP of Clinical Operations Latin America & North America at inVentive Health Clinical; Silvia Zieher, VP, Clinical Development, Latin America Operations at INC Research; and Ramita Tandon, SVP and general manager at inVentive Health Clinical.

8. What is the Current State of eTMF? 10/17/2013

   So much has been written and published about the use of electronic trial master files (eTMFs) that it is difficult to understand exactly where the industry stands on acceptance of the technology. At times it seems some firms are not even referring to the same thing when referencing eTMFs. Enterprise software company NextDocs has conducted a survey of 60 companies to gain both qualitative and quantitative insights into the use and perceptions of eTMFs by end users. The results have been released in a report titled The State of Trial Master Files. 

   “The biggest trend we see in the clinical space is a gap that exists between the great strides made by some of the industry leaders (especially ones where legacy document management is not as entrenched) and firms that seem to be laggards in regard to adopting the technology,” says Kevin Potts, VP of marketing for NextDocs. “The firms that are slow to adopt the technology seem to believe eTMF is nothing more than a system used to scan and archive documents after you are done using them. Many companies will tell you they are already using eTMF, but the bigger question is what are they really doing with it.”

9. The State of Electronic Trial Master Files (eTMF) And The Challenges Companies Face 10/15/2013

   NextDocs conducted the “State of TMF” survey in Q1-Q2 2013 to better understand how companies are managing trial master files. The survey also queried respondents on the major features, obstacles, and metrics surrounding the implementation of an electronic trial master file (eTMF) system.

10. Should Russia Be Your Choice For Clinical Trials? 8/27/2013

    Years ago, being a CRO in Russia was not an easy endeavor. Politics, as well as the state of medicine and healthcare in the country, made it a difficult place to perform trials. With improvements that have been made in both medicine and technology, and the changing political landscape, the country is now a very different place. This has significantly improved the job of the CRO, and has made the country a growing and successful area to conduct clinical trials.