ACT

May 08/2018


news roundup

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Applied Clinical Trials and SCORR want to know more about your innovations in clinical trial design. Please take this brief, 25-question survey to give us insight on your design process, resources needed to make changes, benchmarks used to measure performance of changes, and the impact new clinical trial designs have had on your work.


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The Future of ECOA
Tuesday, June 12, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ClinicalStudyDataRequest.com Announces Partnerships with Global Academic Research Funders

ClinicalStudyDataRequest.com announced new collaborations with four major non-profit partners: The Bill & Melinda Gates Foundation, Cancer Research UK, Medical Research Council, and Wellcome Trust. These new consortium partners will expand researchers' access to patient-level clinical trial data.


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Functional Service Models Reimagined: Integrating services and innovation for accelerated clinical development
Wednesday, June 6, 2018 at 11am EDT
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Novartis Launches FocalView app

Novartis announced the launch of its FocalView app, an ophthalmic digital research platform created with ResearchKit. This app is designed to collect data directly from patients in order to track disease protection and allow them to particpiate in ophthalmology clinical trials from home.


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Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC-MS: Latest Trends and Recommendations
Live Webcast: Tuesday, May 15 at 11:00am EDT
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Clinical Trials Xpress, Named as a PAREXEL Strategic Site Alliance Network Member

Clinical Trials Xpress (CTX), an initiative of the University of Texas System, has been named by PAREXEL as a member of its Global Site Alliance Network. Within this network, CTX will work side-by-side with PAREXEL to promote more clinical development of drug therapies through research.

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Considerations when Addressing the Challenges of Time, Cost, and Data Standardization in Clinical Trials
Live Webcast: Thursday, May 10, 2018 at 11am EDT/ 8am PDT/ 4pm BST/ 5pm CEST
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In this edition

Take Our Survey!
Barriers and Solutions to Smart Clinical Program Designs
FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development
Oncology Therapy-Focused RACT Emerges

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Operationalizing Gene Therapy Trials
Live Webcast: Tuesday, May 8, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST
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Events

Managed Access Programmes and Accelerated Pathways
BIO International Convention
American Biomanufacturing Summit 2018
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Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022
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Articles

Barriers and Solutions to Smart Clinical Program Designs

How the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."


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Six Strategies for More Accurate Clinical Trial Forecasting & Budgeting
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The Impetus for Natural History Studies in Rare Disease R&D

The use of natural history (NH) studies early in clinical research can help facilitate development programs for orphan drugs.

Blog Posts

Dubious UK Promises on Post-Brexit Clinical Trials

The British government continues to offer guarantees and reassurances about the post-Brexit future of its life-sciences sector despite the obvious failure so far to get even close to negotiating a withdrawal agreement with the EU.


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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
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FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development

Recent legislation authorizes further assessment of FDA eligibility policies and of NIH research standards.


Oncology

Oncology Therapy-Focused RACT Emerges

Newest revelations suggest Risk Assessment Categorization Tools are now becoming therapeutic area-specific, as an oncology-based risk library is now surfacing.

 

Maximizing Immuno-Oncology Clinical Trial Success

Cancer immunotherapies require different standards for evaluating their safety and effectiveness. Understanding these standards—and the other major challenges of immuno-oncology studies—is critical to drug development success.


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Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Todd Baker
Group Publisher
todd.baker@ubm.com