International Clinical Trials |
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Editor's Comment
Graham Hughes introduces this issue by outlining the two sides of clinical trial data – transparency on the one hand, and protection on the other hand – among other topics.
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Site Activation
Head Start
First and foremost, each clinical trial needs to undergo site activation – which can be a lengthy and tiresome process, says Melissa Easy at DrugDev. There are, however, three models at hand using the most recent technology to help facilitate trial start-up.
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Paediatric Trials
On Your Doorstep
With paediatric trials becoming more common, Dr Graham Wylie at MRN states that home visits in particular are part of an increasingly patient-centric healthcare movement.
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End Point
Activity Surge
Graham Hughes reports on the increasing activity in M&A over the past few decades, and outlines reasons for merging and the implications for consumers and stakeholders.
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Marketing Applications
The Final Step
Representing the last hurdle in bringing a drug to market, marketing applications can be costly and time consuming to develop. Rho’s David Shoemaker presents different application models to facilitate this procedure.
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Regional Trials
Across the Globe
ICT takes a closer look at the clinical trial landscape in different markets – namely Latin America, the MENA region, Indonesia and finally, in the EU.
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Latin America
Susana Bule and Cláudia Carvalho at Eurotrials reveal that the Latin American market has been demonstrating great potential for clinical research and pharmaceutical development for some years now. The spending in healthcare has also been increasing, which shows the governments’ prioritisation of this matter.
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The Middle East and North Africa
Cellia Habita at ARIANNE explores clinical trials in the Middle East and North Africa, and explains why these areas should not be neglected in favour of more familiar countries.
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Indonesia
Rutger Oudejans at UBM EMEA highlights the importance of local expertise in Indonesian clinical trials, and describes why this region has gained significant value in pharma as a whole.
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European Union
Srikanth Venkataraman at Frost & Sullivan explores patient recruitment for global clinical trials – with a focus on the EU – which he believes are going to be transformed by digital platforms and mobile technologies.
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Data Protection
Under Wraps
8MAN’s Jens Puhle believes that keeping data safe from rival organisations and potential theft is paramount in pharma – with threats being closer to home than one might think.
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Clinical Trial Data
Access Denied
Graham Donaldson at TRAC Services looks at the transparency of data versus the protection of commercially confident information in light of the latest regulations introduced to Europe.
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Data Analytics
The More, The Merrier
There is no doubt that data plays an important role in pharma – and with a growing focus on the patient in the form of personalised medicine and services, this role is set to further expand, states Wipro Ltd’s Nitin Raizada.
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Data Formatting
Preparing for SEND
Roman Radelicki at SGS believes that implementing the standardised electronic format SEND can help streamline the process of submitting electronic data in non-clinical studies, and can further save time and money.
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Rare Disease Treatment
Making a Difference
World Courier’s Sue Lee discusses the growing importance of orphan drugs, which must be produced in small quantities for a limited patient population, and questions the fact that only 5% of rare diseases have treatments available.
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Clinical Supply Chains
On Demand
Adaptive trial design is becoming increasingly popular, observes Catalent’s Dr Paul Ingram, before investigating its implications on supply chain efficiency.
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Logistics and Handling
Touch Point
Essangui Mbaitjongue at Thermo King is convinced that with the help of tighter temperature guidelines, the shipment of pharmaceuticals can be facilitated – thus enabling them to reach their destination unharmed.
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Microbiological Labs
Driven by Results: Part 2
Olga Sazonova, Veronika Khokhlova, Maxim Belotserkovsky and Andrey Karelin at PSI CRO continue examining quantitative urine culture studies, and consider country-specific differences.
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Pharmacogenomics and Oncology
Special Treatment
United BioSource Corporation’s Dr Don Gabriel outlines the implications of the use of pharmacogenomics – the study of individuals’ genetic variations – on oncology, and how that impacts the way patients respond to medication.
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Oncology Research
Relationships Matter
Dr Martin Lachs at ICON examines the connection between sites and CROs when enrolling patients in oncology studies, and considers how to further improve this relationship.
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