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International Clinical Trials

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Spring 2013

   
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Regulatory & Business Practice
Data Transparency

Going Public?

Should all clinical trial data be made publicly available, or would this be an alarmist move that could cause mistaken safety concerns? Rupert Gilbey from Samedan Ltd heard both sides of the argument at a recent industry debate.
 
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Innovation in R&D

Box Clever

The UK government’s new Patent Box preferential tax regime recognises the strategic and economic importance of the life sciences industry. Nick Beckett at CMS Cameron McKenna fills us in.
 
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Clinical Trial Management
Home Trial Services

Inside Story

A new and powerful tool for improving recruitment and retention, home trial support can speed up trials and reduce patient burden. Graham Wylie at Medical Research Network outlines the nuts and bolts of this service.
 
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Project Management

Leading Edge

Eric Morfin at Critical Skills Inc examines the importance of nurturing future project managers and leaders in clinical trials, outlining the appropriate behaviour-based skills and styles.
 
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Patient Engagement

Get Connected

Mobile and digital technology can be used to capture clinical outcomes at the point of experience, helping pharma companies to engage with patients globally, in any language at any time. Tim Davis at Exco InTouch explains.
 
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Professional Standards

Live and Learn

A lack of competency-based qualifications for clinical research points to the need for internationally recognised accreditation. Martin Robinson at the International Academy of Clinical Research proposes a new framework.
 
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Patient Adherence

Missing Link

The lack of patient adherence recorded in many clinical trials leads Dorothy Smith at Consumer Health Information to ask: how safe is the prescribed dose of some drugs on the market?
 
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Investigator Grants

Forward Thinking

Linda Drumright at IMS Health considers the tricky issue of estimating investigator grants, emphasising the value of using historical performance benchmarks to more accurately forecast the costs.
 
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Progression-Free Survival

Under Review

An independent review committee can add value to the use of progression-free survival endpoints in oncology trials. A potential new approach is explored by Kristin Borradaile, Kevin Duffy and J Michael O’Neal at BioClinica.
 
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Phase 1 and 2a Trials

Early Action

International perspectives on a host of hot topics were shared at the recent Phase 1 and 2a Clinical Trials Conference, attended by Graham Hughes.
 
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eCLINICAL
Electronic Patient Data

ePRO Update

Electronic platforms could give a new lease of life to patient-reported outcomes for clinical trial endpoints. J Jason Lundy at the Critical Path Institute looks at the adaptation of paper-based instruments and what the future might have in store.
 
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Regional trials
Infectious Diseases: China

Eastern Time

Its large pool of treatment-naïve patients makes China a potentially strong market for clinical studies, although protracted approval timelines, cultural barriers and competition for resources are among the challenges. Steven Lobel, Carol Olson and Beth Tulip at PPD report.
 
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Asian Markets

Culture Trip

Amid the advantages of the Asian region, trial sponsors should ensure that results are not compromised by linguistic, cultural and behavioural differences, says Gary Muddyman at Conversis.
 
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data management & statistical analysis
ECG Measurements

Use and Principles of Automated Measurements

Tim Callahan at Biomedical Systems makes the case for the use of automated algorithms from electrocardiogram machine manufacturers and third-party vendors to ensure consistent, high-quality readings in early phase trials.
 
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Central Labs
Lab Selection

Balance of Evidence

Central lab partners are often selected based on company policy or previous work, rather than project-specific considerations. A Karelin, M Belotserkovsky, V Khokhlova and A Kumar at PSI set out a process for making the optimal choice.
 
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Interview
Industry Interview

Thinking Allowed

ICT quizzes Rory O’Hare at Greenphire about his concerns over global payments and realising its strategic potential.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Kieran Coulton named new Chairman at ChargePoint Technology

ChargePoint Technology, specialists in contained and sterile powder transfer solutions has announced the appointment of Kieran Coulton as Chairman. Coulton is an accomplished leader in automation and manufacturing with a track record of 36 years in the industry. Having previously served as President Global Industry for GE Power Conversion, Kieran brings with him a wealth of experience and an ability to achieve excellent levels of business growth.
More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

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