Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

TORONTO (PRWEB) OCTOBER 27, 2021 — Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the clinical trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during initial planning, the focus is usually placed predominately on recruitment and not...

Clinical Research: Phase 1 - Phase 4

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

Introduction Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is important, and early, careful planning is critical. This white paper explores key considerations for...

Clinical Research: Phase 1 - Phase 4

Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study

Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy...

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Optimizing Study Execution for Advanced Therapies

Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight...

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...

Clinical Research: Phase 1 - Phase 4

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 Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

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...