Peer-Reviewed Articles

Human Gene Transfer Research: What Clinical Research Professionals Need to Know

By Chris Jenkins, PhD, Lindsay McNair, MD

This experimental technique is being studied to see whether it could treat certain health problems.

Death Waivers Draw an Incomplete Picture of Drug Safety

By Lisa Carlson, Margarita Mare, MD, Nickolai Usachev, MD, Maxim Belotserkovskiy, MD

Gaps in the current practice of reporting deaths due to main disease progression in clinical trials.

Quality Drivers In Clinical Trial Conduct

By Michael J Howley PA-C, PhD, Peter Malamis, MBA

Adopting scientific quality measurement that recognizes that clinical trials are a service will reap benefits.

Quality Metrics for Clinical Trials

By Jonathan Rowe, Denise Calaprice-Whitty

A case study by Pfizer & The Avoca Group on the development of an overarching strategy for Pfizer’s clinical trial quality metrics.

Blogs

Pharma Faces More Comparisons of Drug Costs & Effectiveness

By Jill Wechsler

Will emerging drug cost assessment initiatives provide useful, valid information on total drug value?

Genomes, Big Data and the Journey to Precision Medicine

By MaryAnne Rizk, PhD, Tom O’Leary

This month marks a landmark in the quest for personalized medicine and the growing role of big data in health sciences – from clinical development through tracking patient outcomes long after a therapy has reached the market.

Is “Sunshine” Curbing Clinical Research?

By Jill Wechsler

Doug Brown, director of the data sharing & partnership group in CMS’ Center for Program Integrity, acknowledges that the data on payments to PIs seem confusing.

Events

Life Sciences Collaboration and Transaction Accounting Congress

September 24 - 25, 2015
DoubleTree Suites, Boston, MA

Mergers & Acquisitions and Strategic Alliances in Life Sciences

October 14 - 15, 2015
The Ritz-Carlton, Philadelphia, PA

Prep Forum for the New EU Clinical Trials Regulation

October 19 - 20, 2015
Wyndham Historic District , Philadelphia, PA

Data Analysis

Enrolled Patient Numbers

Randomized Clinical Trials (RCTs) have constituted the foundation for new drug approvals for over fifty years.

Inclusion/Exclusion Criteria Show Minimal Rise

Few topics occasion the lamentations of clinical trial professionals more than the topic of patient inclusion/exclusion criteria in clinical protocols.

eCOA and ePRO Provide Accuracy in Data Capture

Accuracy in data capture methods has always been and will continue to be a foremost necessity in pharmaceutical clinical trials.

Noteworthy

How Technology Can Help ClinOps Leaders Build a Quality Culture

By Jud Gardner

Clinical trials are time sensitive, costly endeavors with high-risk and high-expectations at every juncture.

Redefining the Sciences of Drug Safety

By Dr. Magalie Emile-Backer

Innovative surveillance tools and technologies have transformed the field of drug safety into a more proactive, dynamic analytical process.

New EU Clinical Trial Regulation: Headway and Concerns

By Lisa Henderson

While approved last year, it does not apply earlier than May 2016—leaving interested parties only nine months to prepare for its arrival.

eBooks

 

Risk-Based Monitoring in Clinical Trials 

This latest, updated eBook on Risk-Based Monitoring from Applied Clinical Trials includes the latest information on the topic being discussed around clinical trials. Includes pitfalls to avoid when implementing an RBM strategy, and an update on Cancer Research UK's implementation.

 

 

Clinical Trials Project Management 

Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this eBook seeks to instruct others on best practices.

 

 

Real World Evidence in a Clinical Trials World

With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding.