Peer-Reviewed Articles

With the inherent limitations of traditional data sources, this overview explores the definitions and strategic fundamentals that inform machine learning and modeling techniques.

Homecare access to patients participating in clinical trials can prove beneficial for patients, sites and sponsors by incorporating the trial into their everyday lives.

A how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.

How the adoption of electronic clinical outcome assessment in trials can drive increased communication and patient reporting of events.

Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.

The time is now for sites and sponsors to put away fears associated with data acquisition and monitoring technologies-and better support the regulatory push in recent years for standardized adoption of paperless trials.

Conducting a clinical trial is a difficult process no matter the factors involved, but become especially challenging when ran from sites that have no prior experience and limited resources. A little preparation and forward thinking can go a long way in reducing data loss and executing a successful study.

Comparing mean vs. median to uncover the full data picture of site-level performance.

In a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.

In 2014, EU Regulation n.536/2014 represented a significant step toward transparency of clinical trials in Europe. However, despite the EMA’s policy 0070, which reinforced this concept, several aspects remain to be determined or evaluated, leaving room for additional requirements and local interpretation.

Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs. To meet greater demand, the role and profile of Project Managers needs to continuously adapt to an ever changing clinical trial environment.

A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.

The Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.

Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance.

Study finds that despite the use of new approaches to streamline and accelerate study start and improve site selection and activation, the impact on start-up cycle times has been limited. The reasons why are explored.

A proposed operational framework to support digital- and mHealth-based clinical trials in Africa.

Exploring the benefits from cross-company data sharing for study planning and investigator selection.

An examination of recent failures in Phase III studies and innovative approaches to reduce risk.

The largest antihypertensive trial ever conducted throughout North America, ALLHAT, was organized using a coordinating center model for oversight. Regional coordinators played a key role in carrying this trial out.

With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.

Outlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.

Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.

Outlining those technologies best able to raise the data and process quality of risk-based monitoring.

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.

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

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.

Pediatric trials now feature increased modeling and analytics for safer drug dosing and response.

The smaller biopharmaceutical company perspective on mastering oncology immunotherapy clinical trials.

A number of top-selling biological products in key therapeutic areas such as cancer, diabetes, and rheumatoid arthritis have recently lost, or will soon lose, patent protection.

Two of the most important elements to the integrity of a controlled clinical trial are the patient randomization and the treatment blinding. With a focus on block pattern distribution, four methods of randomization list creation are analyzed.