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...
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...
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...
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...
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...
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...
This week’s Tales from the Road is from Angi Robison, Executive Director, Strategic Development Department, Rare Disease & Pediatrics, who gives us a bit about what she took away from the World Congress Patient Advocacy Summit back in October. Greetings from the road! I just had an excellent two days at the World Congress Patient Advocacy...
Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was...
A customer asked us to do a chart review of patients with hypophosphatasia, an extremely rare metabolic bone disease with a live birth incidence of about one in 100,000. The perinatal variant is rapidly fatal. A proliferation of protocols Initially informed consent was required if local regulatory authorities and/or IRBs required it. Then the Premier...
We knew going in that it could be the perfect recruiting nightmare. We were looking for children ages 2 to 12 for a dermatology study that involved long visits and extensive blood draws. We had extremely complex inclusion/exclusion criteria. And most parents wanted nothing to do with it. “Hello, it’s me again.” We sent feasibility...