Peer-Reviewed Articles

Overcoming Early Phase Oncology Challenges

By Karen Ivester

As cancer immunotherapies continue to emerge, the need for rigorous evaluation to assess the safety and efficacy of these products in clinical trials is critical. Doing so in the early phase setting requires a foundational focus in such areas as NME selection, protocol development, patient population, and investigator and site selection.

Investigator Characteristics and Participant Recruitment in ALLHAT

By Megan Souder, Linda B. Piller, MD, Charles E. Ford, PhD, Debra Egan, Therese S. Geraci, Leslie A. Holland-Klemme, Gail T. Louis, Robert A. Pospisil

Data on the relationship between investigator characteristics and cardiovascular clinical trial patient recruitment are extremely limited in scientific literature. An analysis of ALLHAT, the largest antihypertensive clinical study ever conducted, identifies key investigator and site characteristics that can strengthen subject enrollment.

How Integrated Value-Based Planning can Lead to a Leap in Development Productivity

By Frederic L. Sax, MD, Marla Curran, DrPH, Sarah Athey, Christoph Schnorr, MD, Martin Gouldstone

Integrating evidence-based planning and real-world evidence has the potential to reap big gains for development productivity. Achieving this through a "Three-Pillar" approach emphasizing knowledge sharing, evidence needs, and scenario risk-building is proposed.

A Centralized Monitoring Approach Using Excel for the Quality Management of Clinical Trials

By Adam Beauregard, Lyne Lavoie, Fernand Labrie

Pilot study evaluates the success of building quality into clinical trials using a plan-do-check-act (PDCA) approach to quality management.


Safety 360 – A Holistic Approach to Pharmacovigilance

By Bruce Palsulich

The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.

Califf Sidesteps Drug Pricing Complaints from Senate

By Jill Wechsler

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Pressure Mounts for Greater Clinical Trial Data Transparency

By Jill Wechsler

Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.


Clinical Trial Agreements
December 2, 2015 - December 3, 2015 | Philadelphia, PA

CBI's Clinical Data Disclosure and Transparency
January 26, 2016 - January 28, 2016 | Philadelphia, PA

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

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Data Analysis

Only 35% of Sponsors Have Met Their Outsourcing Match

We all need help sometimes. For pharmaceutical companies, this often comes in the form of a reliable and competent contract research organization.

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.


Cold Chain Logistics' Impact Clinical Trial Data Integrity

By Mark W. Sawicki

Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.

Business and People News

By Applied Clinical Trials Editors

Executive moves abound in the CRO world this month; plus a list of the 2015 RAPS Fellows.

Engaging Physicians, Staff and Patients for Oncology Trials

By Cathy White

Accruing patients depends greatly on engaged, enthusiastic PIs, as they are the gatekeepers in helping patients decide to participate in clinical trials. Building staff awareness and enthusiasm are also essential for retaining participants.



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.


Metrics and Analytics: How to Evaluate Clinical Operations

As the push to contain clinical trial costs and make informed business decisions continues, more pharma and CROs are looking at internal and external benchmarking and metrics to evaluate their performance—both successes and challenges. This e-Book includes articles that show how analytics uncover problem areas in clinical operations, as well as metrics and databases that are used to pinpoint internal or external performance issues.



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