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| home > ict > Spring 2018 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
ICT's Editor Dr Graham Hughes introduces the key focus topics in these editions of ICT and EPC, highlighting a number of articles.
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Clinical Trial Oversight Management
Perfecting Performance
When dealing with new revisions in the ICH E6 (R2) guidelines, Gabriele Faist and Heike Schön at LUMIS International discuss how the implementation of keyperformance indicators could be beneficial.
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Regulation Changes
Clinical Navigation
With new developments in pharmacovigilance being continually implemented, Nick Barker and Katharine Colbert at Medpace express that sponsors andmarketing authorisation holders worldwide must ensure they are prepared
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Obstacles in Cancer Research
Essential Steps
Through a Q&A, Peter Langecker, Brian Travers, and Barb Geiger at Clinipace explain to ICT the intricacies that must be considered within oncological studies.
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Alzheimer’s Research
Improving Success Rates
Significant progress within clinical trials for Alzheimer’s is being made. Dr Michael F Murphy at Worldwide Clinical Trials says new trial designsare now addressing previous research challenges.
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Spotlight
York Health Economics Consortium
York Health Economics Consortium is a health economics consulting company owned by the University of York. It provides a range of services,including economic modelling, literature searching, systematic reviews,
network meta-analyses, outcomes research, and applied research and training to the NHS and the pharmaceutical and healthcare industries |
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Oncology Trial Validity
Imaging Innovations
Working alongside effective site training, today's imaging analysis technology could bring improvements to the quality, timeline, and cost of oncology trials. Sophie Winandy at ERT explores how.
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eClinical Improvements
A New Pathway
Jeff Lee at Bracket details the ways in which technological approaches alongside unified thinking can enhance patient engagement, becominga key asset within clinical research.
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EMA First-in-Human Guidance
Exponential Developments
As regulations for first-in-human trials progress, Bradley Joblin at Q-Pharm examines the new considerationsthat must be made within early phase development.
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The Sponsor/Vendor Relationship
Key Relations
Shanelle Mehta at The Clinigen Group explores how outsourcing is becoming common practice within the pharmaceutical and biotechnology industries, thereby creating a good sponsor/vendor relationship and a reliable process.
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End Point
Public Perception
ICT Editor Dr Graham Hughes considers the role of clinical trials and how they are
publicly perceived
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Oncology Clinical Trials
Optimising Outcomes
Routine cancer care can be enhanced by integrating electronic patient-reported outcomes and clinical outcome assessments. Katie Garner at CRF Health examines how.
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The Patient Experience
The Engagement Equation
Modern clinical trials rely on patient engagement. Aaron Fleishman and Sarah Mandracchia at BBK Worldwide analyse the new tools and techniques that must be utilised to ensure all trial stages are successful.
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Digital and Cloud Developments
Revolution or Evolution?
As the industry begins to embrace new clinical methods, David Goldston at Veracity Logic considers how it disrupts conventional, long-standing trial management.
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News and Press Releases |
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3P Biopharmaceuticals receives FDA approval
[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >> |
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events |
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SCOPE Summit for Clinical Ops Executives
18-21 February 2020, Hyatt Regency, Orlando, Florida, US
Celebrating its 11th successful year,
SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of
four stimulating days of in-depth discussions in 20 different conferences, 3
plenary keynote sessions, the annual Participant Engagement Awards, and the
ever-popular interactive breakout discussions, the programming focuses on advances
and innovative solutions in all aspects of clinical trial planning, management
and operations
More info >> |
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