Patient and Stakeholder Engagement

Patient and Stakeholder Engagement

Premier Insight 254: Dealing with the Unexpected: Surprisingly Fast Enrollment

Normally we’re ready for anything at Premier Research. We anticipate every contingency. This time the patients caught us off guard, by rushing to enroll almost as soon as word of the study got out. That’s because we were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists,...

Consulting

Premier Insight 235: It’s About How the Social System Works, Not Just the Science

The assignment sounded simple enough: Recruit 24 patients for a Phase 1 proof-of-concept study of inflammatory bowel disease. The first CRO that received the assignment showed how difficult it really was: They were able to recruit only nine patients in a year and a half. At that point, the sponsor asked Premier Research to step...

Patient and Stakeholder Engagement

Premier Insight 269: Recruitment in Reverse: Motivating Patients to Find the Study

For a fertility study, we needed to recruit young women who had had at least three unexplained miscarriagesand who were currently trying to conceive. The field of prospective recruits was huge: all women 18 to 37 years old living in the United Kingdom. The challenge: cost-effectively reach, screen, and randomize 150 patients. The solution: motivate...

Consulting

Premier Insight 263: The Case of the Elusive Protocol

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...

Patient and Stakeholder Engagement

Premier Insight 242: How Ramping Up Communications Helped Overcome a Next-to- Impossible Recruitment Challenge

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 265: Complete Response: Lymphoma Trial A Surprising Success For Five Patients

A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma is still almost three years from completing patient follow-up, but already it has succeeded beyond expectations in the form of five patients declared disease-free a year and counting. The Phase 2 trial involved a CD19 antibody that was tested at 26 sites...

Patient and Stakeholder Engagement

When Rare Diseases Take Research Far Afield: Dec. 15 Webinar

PHILADELPHIA, December 15, 2015 — Researching rare and ultra-rare diseases sometimes means taking the study to the patients, setting up sites in countries unaccustomed to hosting clinical research. Premier Research will examine the challenges of conducting trials in such unconventional locales at a webinar on Tuesday, Dec. 15. Opening sites in countries where trials are...

Patient and Stakeholder Engagement

Premier Research’s New Pediatric Survey Reveals Challenge in Identifying Sufficient Clinical Patients

A new survey of clinical trial decision makers commissioned by Premier Research reports that identifying an adequate number of children suitable to be patients is far and away the single greatest challenge in conducting a pediatric clinical trial. The Premier Research survey also revealed a surprising lack of awareness among clinical trial sponsors that, as part of the Safety and Innovation Act (FDASIA), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet specific criteria.

Patient and Stakeholder Engagement

Premier Research’s New Survey of Rare Diseases, Orphan Drugs Highlights Regulatory Challenges

A new survey of clinical trial decision makers commissioned by Premier Research reports that nearly two-thirds (64%) of respondents said that among the most difficult factors in recruiting for a rare disease or orphan drug clinical trial was not only finding patients to join and remain in trials, but identifying and setting up investigative sites for studies.

Patient and Stakeholder Engagement

Premier Research Experts to Examine Pediatric Studies at DIA 2014

On Thursday, June 12, 2014, Premier Research announced that a panel of their experts will discuss the design of pediatric studies, recruiting for pediatric research, and the importance of corrective and preventive actions to a company’s quality system at the 2014 Drug Information Association conference, June 15–19 in San Diego.