Pediatrics

Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results.  As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

Rare Disease and Pediatrics Expert to Address WODC Europe November 7

DURHAM, N.C., October 30, 2018 — Angi Robinson, Executive Director for Rare Disease and Pediatrics at Premier Research, will discuss clinical development strategies for genetic rare disease research November 7 at the World Orphan Drug Congress in Barcelona. Ms. Robinson’s presentation, starting at 2:20 p.m., will examine management of confirmatory testing and specialty labs, the...

Consulting

The Placebo Problem, Part 13: The Pediatric Placebo Response

This is the thirteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. Until now, our Placebo Problem series has focused exclusively on the placebo response in adults. Today we turn to another population: kids....

Consulting

Designing Pediatric Analgesic Treatment Regimens and Assessing Their Outcomes

When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste” from adult trials. Likewise, extrapolation of efficacy and risks from adult studies is not always reliable due to developmental and physiological differences. Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group being...

Clinical Research: Phase 1 - Phase 4

The Top 5 Concerns for Pediatric Study Participants

Patient and parent engagement is crucial for successful pediatric drug trials. That’s why the best strategies are ones that encourage proactive involvement beginning at the early stages of protocol development through study conduct and eventual results-sharing. And that includes input. We partnered with iCAN in 2015 to ask pediatric patients, their family members, and even their friends...

Consulting

Experts to Discuss Pediatric Medicines, Wearables at EuroMeeting 2017

DURHAM, N.C., March 27, 2017 — Two Premier Research drug development experts will speak at the Drug Information Association’s EuroMeeting 2017, March 29-31 in Glasgow: Dr. Thomas Laage, Senior Medical Director, will take part in a session on optimizing development of pediatric medicines on Thursday, March 30, from 11 a.m. to 12:30 p.m. Dr. Laage...

Clinical Research: Phase 1 - Phase 4

The Top 7 Considerations to Take When Designing Pediatric Analgesia Trials

Children aren’t little adults: Pediatric populations have needs and physiological factors that set them apart from adults. However, it’s taken time for that philosophy to catch on within the clinical research community at large. When writing protocols for trials of acute pain in pediatric populations, researchers must take these unique needs of children into account to meet regulatory...

Consulting

Designed Especially For Kids

Children are not little adults, and protocols for pediatric pain studies must take into account the unique needs of children to meet regulatory and ethical standards and protect this vulnerable population from untreated pain. Sponsors of pediatric analgesia clinical trials are tasked with designing studies that are both realistic to execute and sufficiently rigorous to...

Consulting

Involving Children, Adolescents, and Parents in Pediatric Drug Development

Actively seeking the involvement of pediatric patients and their parents throughout the life cycle of a clinical trial can help drive recruitment, retention, patient satisfaction, and, ultimately, the success of the study. Involving children in clinical research has long been a sensitive topic associated with several ethical dilemmas and operational challenges. There is now a...

Clinical Research: Phase 1 - Phase 4

The Science and Art of Conducting Clinical Trial Feasibility in Rare Disease and Pediatric Studies

Rare disease and pediatric studies present significant challenges, including country selection, site selection, and patient recruitment. A thoughtfully-designed, well-executed feasibility study can help sponsors obtain a realistic assessment of the best path forward for developing and conducting successful global clinical trials. Performing a thorough assessment of clinical trial feasibility is an important early step in...