EDITOR'S DESK

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  Three Critical Steps To Rescuing Your Clinical Trial

  You did all of the required due diligence. You took the time to select what you felt was the right CRO. You verified its track record, qualifications, and expertise. You even took the time to personally visit the site, to ensure the two companies would share a common culture and commitment to quality. Still, despite all of your efforts, the trial was not going as planned. The last thing anyone wants to do is switch CROs in the middle of a trial. But if you get to the point where making a change is your only option, how do you best accomplish this difficult task?

  Alicia McNeil and Elizabeth Kelchner, clinical data scientists for Rho, a full-service CRO, know personally how difficult this task can be. The company has years of experience working on dozens of federal and commercial rescue studies for clients. In their positions at Rho, McNeil and Kelchner are often called upon to resolve issues that arise whenever a clinical study does not go as planned with the CRO originally selected by the sponsor. This experience has taught them how to properly identify the red flags that indicate a study may not be going as planned, and is in need of remediation.

• Destructive Automation: Coming Soon To A Clinic Near You!
• Where Are Salaries In The Global CRO Industry Headed?
• The Future Of Clinical Trials
• Data Support Clinical Validity Of Pharmacogenomic Testing

CLINICAL PERSPECTIVES

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  FDA Safety Labeling Requirements

  Prior to 2007, the U.S. Food and Drug Administration’s labeling authority was limited; the agency could only request changes to the labeling of approved drug products. That changed, however, with the enactment of the Food and Drug Administration Amendments Act of 2007, in particular, section 505(o)(4). In that section, the FDA was given new authority to require safety labeling changes for approved drugs.

  This means the FDA can now order labeling changes if it becomes aware of new safety information that it believes should be included in the labeling of a drug. This article summarizes the FDA’s thinking in this regard, as indicated by its guidance released in recent weeks.

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  Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

  Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

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  ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development

  Emeritus Professor of Clinical Pharmacology, University of Sheffield, UK; Vice President of Translational Sciences (Certara); Head of Consultancy (Simcyp (Certara)); and Chair of the Board of Pharmaceutical Sciences, International Pharmaceutical Federation. By Geoff Tucker

FROM THE INDUSTRY EXPERTS

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  Sites Unseen

  Clinical trials sponsors are moving from 100 per cent site monitoring of research data, thereby reducing costs and saving time, and resulting in a more efficient and successful outcome. However, there are crucial strategies that should be adhered to in order to ensure a streamlined process. By Rick Morrison, CEO, Comprehend Systems

• The Power Of The Cloud
• Pulling The Trigger On Risk-Based Monitoring
• Top 10 eClinical Trends Report

WHITE PAPERS AND CASE STUDIES

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  Comprehend Used For Clinical Operations And Medical Review Across The Entire Versartis Organization

  Versartis engaged Comprehend to facilitate streamlined data review and remote monitoring of clinical trial progress. The primary interest in the use of Comprehend is to provide easy to view and consolidated data that is drawn from multiple electronic sources in real time. The target user of the application is the Clinical Operations team and Medical Affairs.

• Elderly Representation In Clinical Trials: Not A Gray Area
• Integrating Disparate Data For Better Treatment Decisions In Oncology
• Conducting Clinical Trials For Novel Treatments In Psychiatry: A Global Perspective
• Adaptive Trial Designs To Advance Oncology Research

INDUSTRY NEWS

• Report Predicts ‘Push’ Trend In Sponsor, CRO Patient Recruitment

  The recently released ISR report “The Expanding Web of Clinical Trial Patient Recruitment” predicts that sponsors and contract research organizations (CROs) will ‘push’ rather than ‘pull’ patients into clinical trials over the next two years.

   

• FDA And EMA Grant Orphan Drug Status To BI’s AML Drug Volasertib
• Collagen Matrix Receives FDA Clearance For Nerve Injury Conduit
• Baxter’s Rare Disease Drug Meets Phase 3 Endpoint
• AbbVie Advances Lung Cancer Drug To Phase III Trial

FEATURED SERVICES AND PRODUCTS

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  eClinical OS Trial Connect Mobile App

  Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

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  Institutional Review Board (IRB) Solutions

  Whether you are a central IRB in North America or an IRB or Ethics Committee affiliated with a hospital, Trial Interactive has the ideal solution to streamline your processes.  

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  Marketing Intelligence and Strategic Thinking

  Nice Insight offers products and services focused on a variety of marketing intelligence needs. Whether you need a macro understanding of the contract manufacturing industry, or a micro understanding of particular providers and capabilities, Nice Insight can help with your market research needs.

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  CoSign Digital Signatures

  Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records.

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  Polar Pack Gel Packs & Foam Bricks

  Polar Pack® gel packs and foam brick refrigerants are designed to provide reliable temperature protection for a vast array of products and packages.

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  Central Safety Testing

  Routine testing services include standard safety profiles, such as general chemistry, hematology, toxicology/drug screening, urinalysis and allergy – while our innovative esoteric testing covers both nongenetic and genetic testing in such areas as infectious diseases, oncology, pharmacogenomics, and molecular and biochemical genetics.

ARCHIVE NEWSLETTER

• 04.16.14 -- Merck Reports Positive Trial Results For Hepatitis C Treatments
• 04.09.14 -- Bayer Begins Two New Phase 3 Trials For Rivaroxaban
• 04.02.14 -- FDA Approves Pierre Fabre's Hemangeol For Infantile Hemangioma
• 03.26.14 -- Janssen Halts Phase 3 Trial Early For Schizophrenia Drug
• 03.19.14 -- BMS' Cancer Drug Nivolumab Shows Promising Results In Trial