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Volume 16 Issue 3
 
 
Recent FDA Approvals Target Zaire ebolavirus
Volume 13 Issue 2

Recent FDA Approvals Target Zaire ebolavirus

Two drugs recently approved by the US Food and Drug Administration (FDA) treat disease caused by the Zaire ebolavirus, one of the three viral species responsible for...
26 April 2021 Volume 13 Issue 2
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Could COVID-19 be the Catalyst for Change in Future Rare Disease Research?
Volume 13 Issue 2

Could COVID-19 be the Catalyst for Change in Future Rare Disease Research?

Around 300 million people suffer from a rare disease. Figures published in Tufts CSDD Impact Reports (2019) highlight the passion within the rare disease population ...
26 April 2021 Volume 13 Issue 2
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Challenges to Clinical Trials During a Pandemic
Volume 13 Issue 2

Challenges to Clinical Trials During a Pandemic

There has been a difficulty with patient recruitment if patients are homebound or reluctant to go to clinics, or if clinics allow only essential or critical visits o...
26 April 2021 Volume 13 Issue 2
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Digital Health and a New Drug Discovery
Volume 13 Issue 2

Digital Health and a New Drug Discovery

We are currently facing an industrial revolution in the era of big data and artificial intelligence (AI) which affects all fields, including biomedicine. This indust...
26 April 2021 Volume 13 Issue 2
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Bayesian Methods: Transforming the Future of Clinical Research
Volume 13 Issue 2

Bayesian Methods: Transforming the Future of Clinical Research

Today, a range of Bayesian methods or techniques are being used to drive some of the most important scientific advancements of our age, from novel oncology drugs and...
26 April 2021 Volume 13 Issue 2
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FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling
Volume 13 Issue 2

FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling

In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current Medical Device Directive (MDD) for all medical devices distr...
26 April 2021 Volume 13 Issue 2
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How to Develop a Statistical Analysis Plan for Clinical Trials
Volume 13 Issue 2

How to Develop a Statistical Analysis Plan for Clinical Trials

A statistical analysis plan (SAP) is a defined outline of the planned statistical analyses for a clinical trial, including basic and advanced methods. An SAP is cruc...
26 April 2021 Volume 13 Issue 2
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Paving the Way for a Robust Research Ethics Review Structure in Malaysia
Volume 13 Issue 2

Paving the Way for a Robust Research Ethics Review Structure in Malaysia

The foundation of good research is built on sound ethical principles, which require a good rationale, a solid methodology and proper consideration of the important e...
26 April 2021 Volume 13 Issue 2
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Decentralised Clinical Trials in Europe: Lessons from a Pandemic
Volume 13 Issue 2

Decentralised Clinical Trials in Europe: Lessons from a Pandemic

Many elements of decentralised clinical trials (DCTs) have long been available – including mobile devices, remote monitoring, telemedicine, and home health providers...
26 April 2021 Volume 13 Issue 2
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Perspectives of Clinical Trials in Inflammatory Bowel Disease
Volume 13 Issue 2

Perspectives of Clinical Trials in Inflammatory Bowel Disease

Inflammatory bowel disease (IBD), an umbrella term for chronic intestinal disorders with two subtypes: Ulcerative colitis (UC) and Crohn’s disease (CD), the result o...
26 April 2021 Volume 13 Issue 2
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