Current Edition

FDA Expands Eligibility for Cancer Trials in Five Guidance Documents
Volume 11 Issue 4

FDA Expands Eligibility for Cancer Trials in Five Guidance Documents

To broaden patient participation in cancer clinical trials, the US Food and Drug Administration (FDA) in March released four draft guidance documents on cancer clini...
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Successful Studies Start At Feasibility
Volume 11 Issue 4

Successful Studies Start At Feasibility

Study failure is every sponsor’s biggest nightmare, and there are multiple reasons why it could happen. These may include a failure to properly recruit the correct s...
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The Power of Mobile Technology to Optimise Patient Engagement and Study Success
Volume 11 Issue 4

The Power of Mobile Technology to Optimise Patient Engagement and Study Success

In post-industrial countries, the average person spends five hours a day on their smartphone – and cancer patients are no exception. As such, it is a powerful tool t...
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The Changing Face of Site Feasibility
Volume 11 Issue 4

The Changing Face of Site Feasibility

Why a new clinical trial landscape demands greater collaboration and flexibility Travis Caudill of Worldwide writes that clinical research professionals have witn...
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Improving Medicines for Children with Advancements in Paediatric Clinical Research
Volume 11 Issue 4

Improving Medicines for Children with Advancements in Paediatric Clinical Research

Much progress has been made in paediatric medication development since the implementation of paediatric legislation in the US and EU. Marketing authorisation for new...
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Regulatory Convergence and Harmonisation Activities in Latin America
Volume 11 Issue 4

Regulatory Convergence and Harmonisation Activities in Latin America

As demonstrated by numerous initiatives globally, cooperation and convergence activities among national regulatory authorities (NRAs) accelerate the drug development...
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An Insight into Conducting Clinical Trials in Lithuania and Latvia
Volume 11 Issue 4

An Insight into Conducting Clinical Trials in Lithuania and Latvia

Christene Leiper of Onorach examines clinical trials in Latvia and Lithuania, which have been conducted since the early 1990s. The number of studies has increased ev...
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Designing Clinical Trials to Support Pharmaceutical Reimbursement
Volume 11 Issue 4

Designing Clinical Trials to Support Pharmaceutical Reimbursement

The use of health technology assessments (HTAs) to determine whether a healthcare technology should be paid for and at what price is well established in most countri...
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Haemovigilance System in EU and Japan: An Overview
Volume 11 Issue 4

Haemovigilance System in EU and Japan: An Overview

Sridhar S et al. of JSS College of Pharmacy consider the haemovigilance system, which must include all appropriate stakeholders and coordinate between blood transfus...
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Combination Approaches in Immuno-oncology Trials: New Horizons for Multiple Tumour Indications
Volume 11 Issue 4

Combination Approaches in Immuno-oncology Trials: New Horizons for Multiple Tumour Indications

With an ever-increasing amount of clinical trials reporting significant benefits in long-term overall survival of patients with specific cancers following mono-immun...
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