Peer-Reviewed Articles

This three-step process can help managers accurately assess how patient-centric their trials really are.

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.

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.

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.

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.

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.

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.

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.

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

Clinical trials today are more commonly assessing quality of life and other PRO measures as part of post-approval studies to present evidence on treatment effectiveness. It is crucial, therefore, that clinical teams have a strong plan for the capture and analysis of PROs data, and the resources required to draw clinically meaningful extrapolations.

A snapshot of one novel approach in RBM implementation and the data and site performance lessons learned.

Amid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.

A staggering number of clinical trials fail to meet recruitment goals, which leads to delays, early trial termination, or inability to draw conclusions at trial completion due to loss of statistical power.

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

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

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

A survey of Belgian clinical research professionals offers insights into the future of social media

Figure 1: The Problem 

Survey shows what keeps Ukrainians away from clinical trials

A comprehensive survey by Metrics Champion Consortium

Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.

An important criterion for a well-conducted clinical trial is minimization of bias in endpoint assessment.

How the use of eSource, eTMF, and other cloud-based solutions are changing clinical trials

A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.

Peer Review Article

Instinctively, when there are more investigators/sites being deployed for a trial with a defined number of patients needed, we should expect shortened enrollment cycle time. This sounds right, but is it really?