Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Reimagining the Patient Experience in an Evolving Clinical Trial Regulatory Landscape

“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring...

Health Decisions, A Division of Premier Research, Presents at Women’s Health Innovation Summit

Morrisville, N.C., September 13, 2021 — Health Decisions, A Division of Premier Research, will support the Women’s Health Innovation Summit as an Associate Partner for the third year. On Tuesday, September 14 from 12:10 p.m. to 12: 45 p.m. EDT, Health Decisions, an organization that provides clinical research specific to women’s health, will present a...

Clinical Researcher: Real-World Late-Phase Trials – How They’re Helping Sponsors Bridge the Gap from Drug Efficacy to Effectiveness

In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are...

International Clinical Trials: How Contingency Plans Became the New Normal

Over the last decade, there has been increasing interest in mobile health (mHealth) and wearables. The general population has been tracking their steps, checking their heart rates, and monitoring their sleep patterns. Meanwhile, the clinical trial industry has been exploring decentralized trials and remote monitoring options as a way of alleviating the travel burden that...

Premier Research Deepens Support for Oncology Sponsors By Expanding Oncology Leadership Team

A Primer on Cancer Immunotherapy Part 2: The Cancer Immune Response & Mechanisms of Resistance

Immunotherapy has led to substantial advances in cancer therapy in recent years. Still, unpredictable response rates and immune-related adverse events have hampered the widespread use of immune checkpoint therapy to treat cancers. To tackle these challenges, sponsors are increasingly looking to combination therapies as a strategy for improving response and overcoming resistance. In our previous...

A Primer on Cancer Immunotherapy Part 1: Goals & Major Approaches

In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. The U.S. Food and Drug Administration (FDA) has approved six immunotherapies across 19 cancer types and two tissue-agnostic conditions. But widespread...

The Medicine Maker: The Winding Road to the Frontline for Advanced Therapies

According to the Alliance for Regenerative Medicine, there were 1,085 active advanced therapy medicinal product (ATMP) developers and more than 150 phase III trials underway at the end of 2020. These numbers are not small, and they make it clear that ATMPs have much to offer in helping us overcome as-yet undefeated diseases.ATMPs are different...

Medical Design & Outsourcing: Software as a Medical Device: Here’s How the Regulatory Landscape is Changing

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the...

Introduction to CAR T-Cell Therapy Part 2: Additional Considerations & Future Opportunities

Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. Since those initial approvals, three other CAR T-cell therapies have been approved for various hematologic malignancies, but many challenges still limit the therapeutic efficacy of...