Peer-Reviewed Articles

The Growing Availability of Wearable Devices: A Perspective on Current Applications in Clinical Trials

By Niklas Morton, David Blackman

Pilot study evaluates the feasibility of using wearable devices in clinical data collection, including the training requirements for appropriate use of the mHealth technologies and the impact of the model on data quality and patient engagement.

Engagement Shift: Informed Consent in the Digital Era

By Jeffrey Litwin, M.D.

The argument for electronic informed consent as a vital cog in supporting today’s patient-centric push in clinical trials.

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.

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.

Events

 

2016 CDISC Japan Interchange
May 30, 2016 - June 3, 2016 / Tokyo, Japan

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

DIA 2016 52nd Annual Meeting
June 26, 2016 - June 30, 2016 / Philadelphia, PA

Pharmacovigilance Final Rule Summit on IND Safety Reporting
August 16, 2016 - August 17, 2016 / Alexandria, VA

 

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Blogs

Four Tips on Writing an RBM Plan

By Moe Alsumidaie

Many have inquired about writing an RBM plan due to recent changes in industry execution and an increase in RBM experiences. Moe Alsumidaie responds with a brief methodology on developing a risk management process to create an RBM plan.

Low Success Rates Persist for Clinical Trials

By Jill Wechsler

Analysis from multiple reports shows that Phase I clinical trials typically have a low rate of success. The lowest success rate occurs during Phase II of research, while those who make it to Phase III do not fare much better.

Identity Trust is a Must in Clinical Development Collaborations

By Mollie Shields-Uehling

Identity trust platforms assure clinical investigators that their credentials are legitimate by allowing use of a single identity that can be recognized across multiple entities. These platforms support collaboration by allowing drug development participants to access data, sign and exchange documents.

Noteworthy

CAPA as a Tool to Prevent a Warning Letter

By Laurie Halloran

If an FDA investigation results in a Form 483 then it is important to prove that earlier issues have been resolved upon re-inspection. The following steps using your Corrective and Preventive Action (CAPA) program are crucial to appropriately handling and responding to an FDA Form 483 in helping avoid a Warning Letter.

Risk Identification for Centralized Monitoring

By Ashok Ghone

Identifying Key Risk Indicators (KRIs) is an important step in successfully applying risk-based monitoring initiatives to a clinical trial. These factors, within risk management, assist by defining risk areas in order to measure and monitor them centrally throughout the trial.

Adaptive Patient Recruitment for 21st Century Clinical Research

By Joan F. Bachenheimer

A key function in clinical trials, patient enrollment, has fallen behind during a time where technology has played a vital role in the industry. Adaptive patient recruitment allows for clinical data to be collected and reviewed in real-time as to improve enrollment outcomes as they are taking place.

E-Books

Oncology Clinical Trials

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

 

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.

 

 

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