Peer-Reviewed Articles

Interexpert Agreement on Adverse Events’ Evaluation

By Maxim Kosov, MD, PhD, Alexey Maximovich, John Riefler, MD, Eric Batson, Maria Cecilia Dignani, MD, Maxim Belotserkovskiy, MD

Drug safety surveillance, a core focus of clinical trials, can be influenced by subjective judgement, as this analysis of differing expert assessments of adverse drug reactions—and the reasons why—shows.

Imagining the Impossible: Immunity to Cancer

By Chris Smyth, PhD

The smaller biopharmaceutical company perspective on mastering oncology immunotherapy clinical trials.

Learning from Failure, Leveraging Biosimulation for Pediatric Drug Development Success

By JF Marier, Trevor N. Johnson, Suzanne Minton

Pediatric trials now feature increased modeling and analytics for safer drug dosing and response.

Operational Challenges for Biosimilar Studies

By Hazel Gorham, PhD, Rodeina Challand

How careful strategic planning and understanding from the outset can help biosimilar manufacturers address the unique challenges of demonstarting similarity in quality, safety, and efficacy to the innovator product.


CROs & Sponsors Address Global Compliance Challenges

By Jill Wechsler

Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.

Will Another Recession Bash the Biopharmaceutical Industry?

By Moe Alsumidaie

Some in the financial industry have argued that we may be in the midst of another economic recession. The biopharmaceutical industry has shown resiliency during such times and industry trends point to that being the case again.

Patching Up Europe's Data Deficiencies

By Philip Ward

The Innovative Medicines Initiative, a drug research program run by the European Commission and the EFPIA, is inviting bids to run a pilot program regarding preclinical research and development.


CDISC Europe Interchange
April 25, 2016 - April 29, 2016 / Vienna, Austria

Managed Access Programs
April 26, 2016 - April 27, 2016 / Munich, Germany

eSource Data in Clinical Investigations
May 02, 2016 - May 03, 2016 / Philadelphia, PA

Clinical Trial Innovation Summit
May 09, 2016 - May 10, 2016 / Boston, MA

Publication & Clinical Trial Disclosure
June 22, 2016 - June 23, 2016 / Barcelona, Spain

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Data Analysis

A Different Look at Protocol Procedure Complexity

A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from these data.

Competitive Pressure for First-in-Class Drugs is Intensifying

Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.

Number of Countries in Phase III Studies

The number of countries used in commercially sponsored Phase III clinical trials has not changed in recent years.


Tips to Get to (and through) FDA Approvals Faster

By Siva Reddy

While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.

Leverage Site-Owned Tech to Improve Trial Retention

By Moe Alsumidaie, Michele Garibbo

Major Depressive Disorder patients display a reduced ability to feel pleasant experiences known as Anhedonia. Such a feature provides difficulties when treating depression and engaging patients during clinical trials.

Feasibility In the Age of International Clinical Trials

By Vlad Bogin, MD, FACP

When considering countries for basing clinical trials, local input should be solicited for issues that could impact the study.


Cardiac Safety Assessment Update

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.


Clinical Trial Management

Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.


Risk-Based Monitoring in Clinical Trials, 4th Edition

Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.


Planning Successful Clinical Trials in the APAC Region

Catalent Clinical Supply Services enlisted Applied Clinical Trials to develop an eBook that includes the best articles on conducting clinical trials in the Asia-Pacific region. Those articles include: the growing data management services market in China; navigating clinical supply challenges in Asia-Pac regional studies; trends in clinical trials placement, including South Korea as a destination for early phase trials and a look at the future of biosimilars development and steps to develop a logical sourcing strategy. SPONSORED



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