Patient and Stakeholder Engagement

Patient and Stakeholder Engagement

Patient Engagement Lead to Address iCAN Summit July 12

DURHAM, N.C., July 2, 2018 — Premier Research’s head of patient engagement will talk about the role of natural history studies in clinical research at the International Children’s Advisory Network’s Research & Advocacy Summit on July 12 in Edinburgh, U.K. Juliet Moritz, the CRO’s Executive Director, Program Strategy, Rare Disease and Pediatrics/Patient Engagement, will discuss...

Medical and Regulatory Affairs

Operationalizing Gene Therapy Trials

To achieve operational excellence in gene therapy trials, sponsors must understand – and overcome – obstacles ranging from start-up regulations and site selection to patient recruitment and retention. Gene therapy holds promise for treating a wide range of diseases, from cancer and diabetes to rare genetic disorders. It has also sparked great interest because it...

Clinical Research: Phase 1 - Phase 4

Tackling Common Issues in Gene Therapy Trial Operationalization

Between navigating relatively uncharted territory and the practical limitations of most gene therapy delivery systems, ensuring successful clinical trials of these products is a serious challenge for even the most experienced researchers. Compounding this is the long-term nature of most gene therapy trials — it’s not unusual to have follow-up periods of a decade or more....

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

Regulatory Submission Filed a Full Year Ahead of Schedule This case is a story with no drama. No sudden crisis.  No last-minute rescues. It’s about a clinical trial that ran perfectly from start to finish. And that in itself is a story worth telling. The sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID)....

Medical and Regulatory Affairs

Learning to Listen: Voice of the Patient Grows Louder in Product Development

Days before Christmas 2017, a nationwide call went out requesting nominations of patients and caregivers to join a new public/private-sponsored Patient Engagement Collaborative. Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. Food...

Clinical Research: Phase 1 - Phase 4

Patient-Reported Outcomes in Fibromyalgia

Fibromyalgia is a chronic, complex pain condition characterized by widespread pain and a diverse range of symptomatic manifestations, including fatigue, sleep disturbance, dyscognition, diminished physical functioning, and mood disturbances. To date, patient-reported outcomes remain the best method for characterizing the many facets of fibromyalgia. Patient-reported outcomes are gaining traction as a highly effective option for...

Patient and Stakeholder Engagement

AD Trials: Three routes to increasing enrollment

Since the mid-1990s, researchers have struggled to enroll sufficient numbers of patients in their trials for Alzheimer’s disease (AD) therapies. As a result, few new therapies have actually come to market—which is tragic for the 47 million people currently living with the disease. Three key strategies, executed in concert, may help overcome recruitment issues in...

Consulting

5 Operational Considerations for Rare Disease Trials

From researchers to sponsors to patients to advocacy groups to clinicians, rare disease research is full of passionate, driven, and determined people. As the greatest asset to the field, all people involved must be utilized to their greatest potential for a study to be successful. That’s why significant attention must be paid to the operational challenges within...

Clinical Research: Phase 1 - Phase 4

Global Alzheimer’s Disease Trials: 10 Factors to Consider

Roughly 47 million people around the world are living with Alzheimer’s disease (AD) — a number that is expected to increase to 75 million by 2030 and 150 million by 2050. Researchers are pursuing a range of treatments: disease modifying, symptomatic treatment and therapy for behavioral issues. Yet no new therapy has been approved since...

Patient and Stakeholder Engagement

7 Ways to Engage Military Vets in PTSD Clinical Trials

Combat related trauma is significantly affecting U.S. military veterans compared to other military populations across the globe. As many as 20 percent of the U.S. military veterans who served in Iraq and Afghanistan and up to 30 percent of those who fought in the Vietnam War will suffer from Post-Traumatic Stress Disorder (PTSD) in a...