Peer-Reviewed Articles

An Ideal SOP System

By Gabriele B. Schmidt, PhD, Dieter Baier, PhD, Arthur Hecht, * Michael Herschel, MD

A "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.

Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?

By Pirkko Lepola, Susan Tansey, Pamela Dicks, Jennifer Preston, Martine Dehlinger-Kremer

Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.

Investigators’ Experiences in Cooperation with CROs in Clinical Trials in Finland

By Jaana Hynynen, Eija Metsälä, PhD

While several studies and surveys have examined the relationship between sponsors and CROs, there has been little analysis of CRO-investigative site relationships. This study uncovers useful learnings on the positive and negative experiences of investigators in their direct dealings with CROs.

6 Ways Clinical Supply Professionals Can Protect the Blind in Clinical Trials

By Leon Wyszkowski, Steven Yoder, Susan Diehl

This overview of clinical supply blinding methods addresses questions about this topic in the context of the current research environment. The recommendations for protecting the blind come at an important time for the industry and may help fill a gap left by the lack of training resources and published material about this subject.

Blogs

Data Privacy Concerns Between EU-US Intensifies

By Susan Shelby, PhD

Reactive, hastily enforced regulations can easily jeopardize the sound conduct of a clinical trial and its data flow, potentially threatening both subject safety and data quality.

Immunotherapy. It’s Working.

By Terry Murdoch

With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.

Paying for the Research Pay-off

By Peter O'Donnell

EU authorities have been keeping up a constant flow of reminders of just how valuable research programs are–not just in terms of scientific results, but in terms of what the funding can do for improving industry's capacity to innovate.

Events

Clinical Trial Budgeting and Forecasting
February 08, 2016 - February 09, 2016 Philadelphia, PA

Expanded Access Programs 2016
February 23, 2016 - February 24, 2016 Washington DC

SCOPE Summit for Clinical Ops Executives
February 23, 2016 - February 25, 2016 Miami, FL

Patient Centric Clinical Innovation Conference
March 03, 2016 - March 04, 2016 Philadelphia, PA

RBM Europe
March 14, 2016 - March 25, 2016 Barcelona, Spain

CBI’s Clinical Technology Congress
March 29, 2016 - March 30, 2016 Philadelphia, PA


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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 this data.

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.

Clinical Investigators Role in New Drug Adoption

IMS data show the importance of the role clinical investigators play in prescribing.

Noteworthy

Impact of Actigraphy in Clinical Research

By Mathini Ilancheran, Gary K. Zammit

With all the buzz around wearables, actigraphs—which monitor sleep and daytime activity levels—have been around for decades.

Patient-Centric Alzheimer’s Disease Trials

By Moe Alsumidaie

This case study describes how innovative structural design at a study site is leveraging innovative telehealth technologies and nursing home infrastructures to recruit and retain Alzheimer’s patients.

Trial Transparency: PR Hype or Added Value?

By Colin G. Miller

The disruptive influence of data transparency in the status quo of product development may have much longer implications to the healthcare process, and information for patients.

eBooks

 

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

 

eSource—Easier Than You Think

OmniComm Systems enlisted Applied Clinical Trials to conduct a survey on eSource and discovered our audience needed more tools to understand this growing technology area. Based on the results, they crafted a targeted webinar, a successful white paper and sponsored this eBook that features educational articles around eSource and links to OmniComm resources. SPONSORED

 

Patient and Clinician Reported Outcomes in Clinical Trials

As the use of PRO expands in clinical trials, ePRO vendors have expanded beyond this constrained definition. Increasingly, the use of eCOA is being used to encompass all data collected related to the patient, which includes PRO, clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO). This e-Book tackles the changing world of PRO collection in clinical trials.

 

 

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