Patient and Stakeholder Engagement

Clinical Research: Phase 1 - Phase 4

Premier Insight 265: Exceeding Expectations: Durable Remission in Diffuse Large B-Cell Lymphoma

When a developer of a CD19-directed cytolytic antibody for B-cell Lymphoma engaged Premier Research to assist with screening and enrollment in a global Phase 2 study, the Premier project team devised an operational strategy with a goal to exceed expectations. Despite several challenges, the enrollment was completed three months ahead of schedule thanks to consistent...

Premier Insight 258: Glioblastoma Drug Study Yields ‘Unexpectedly Huge’ Advance

A three-nation study of a treatment for recurring glioblastoma showed the therapy more than five times as effective as the typical protocol, an unexpectedly large advance in fighting these aggressive brain tumors. But it was a long road, and the drug’s efficacy was a big factor in extending the trial to five years — nearly...

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...

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...

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...

When Rare Diseases Take Research Far Afield

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 examines the challenges of conducting trials in such unconventional locales in this webinar. Opening sites in countries where trials are uncommon and not thoroughly regulated requires that sponsors really...

Premier Research’s New Rare Disease and Orphan Drug Survey Accentuates Difficulty of Recruiting Patients and Motivating Patients to Take Part in Study

A new survey of clinical trial decision makers commissioned by Premier Research and involving 50 biotech and pharmaceutical firms in North America and Europe reveals that more than two-thirds (69%) of respondents said that among the most difficult factors in recruiting patients into a rare disease clinical trial was not only finding and motivating patients to join and remain in trials, but identifying and setting up investigative sites for studies.

New Survey Reveals Companies’ Concerns About Too Few Pediatric Patients for Clinical Trials Premier Research’s Survey Also Reveals Confusion About PREA and Its EU Counterpart

A new biopharma survey of 55 biotech and pharmaceutical firms in both the North America and European markets by Premier Research reveals that the biggest problem those companies are facing in complying with pediatric regulations is that there may not be enough children who are both accessible and can meet often stringent study criteria to participate in the required clinical trials.

Patient and Stakeholder Engagement

Clinical Research: Phase 1 - Phase 4

Premier Insight 265: Exceeding Expectations: Durable Remission in Diffuse Large B-Cell Lymphoma

Clinical Research: Phase 1 - Phase 4

Premier Insight 258: Glioblastoma Drug Study Yields ‘Unexpectedly Huge’ Advance

Consulting

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