Clinical Research: Phase 1 - Phase 4

Drug Development & Delivery – Maximizing Immuno-Oncology Clinical Trial Success

Hailed by many as the future of cancer therapy, immuno-oncology leverages and unleashes the body’s immune system to recognize and eliminate cancer cells. Immune checkpoint inhibitors have already revolutionized the treatment of certain solid tumors and hematologic malignancies by acting on pathways that cancers co-opt to evade immune recognition. Now, emerging therapies, such as chimeric...

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....

Gene Therapy 101: From the 1960s to Today

Gene therapy is a hot topic in clinical research today — and for good reason! These technologies have the potential to treat — and in some cases even cure — a wide range of conditions, including rare genetic disorders that previously had no effective therapies. What Is Gene Therapy? Gene therapies are a diverse group of...

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)....

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...

Six Ways to Help Manage Staff Trauma Exposure in PTSD Trials

There are currently more than 300 ongoing clinical research studies, mostly in the academic arena, occurring around the world into post-traumatic stress disorder (PTSD) in various populations. But those with PTSD may not be the only ones’ suffering. The members of the research teams trying to help those with trauma illnesses, like PTSD, need to...

Boosting Immuno-Oncology’s Effectiveness Against Cancer

Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his article...

Applied Clinical Trials (Peer-Reviewed) – Maximizing Immuno-Oncology Clinical Trial Success

Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. Immuno-modulating agents such as interleukin-2 (IL-2) and interferon (IFN) have been used in the treatment of some solid malignancies for years, but their use has generally been limited to cancers that are immunogenic, such as melanoma and...

A Vast Unmet Need: Challenges in Alzheimer’s Disease Clinical Trials

Understanding the obstacles inherent in Alzheimer’s clinical trials, from high screen failure rates to lengthy trial durations that are demanding for both patients and caregivers, can help sponsors plan for – and overcome – these challenges. Despite intensive research, nearly 15 years have passed since the lastnew Alzheimer’s disease medication was approved. For those living...

Expert to Discuss Trial Cost Forecasting at Industry Financial Summit

DURHAM, N.C., March 30, 2018 — Predicting the cost of clinical trials is a complex task, and more CROs are providing grant forecasting as a service to produce more accurate projections and give customers greater visibility. A grant forecasting expert from Premier Research will discuss new approaches to predicting trial costs in April at the...