Study Design

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

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

5 Key Takeaways: Drug and Device Development Secrets in the World of Medical Aesthetics

New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. By 2025, the global aesthetic medicine market is projected to be $22.8 billion, nearly one-third of which is expected to be dermal fillers. Premier...

Medical and Regulatory Affairs

PharmaLive: Overcoming the Placebo Roadblock on the Path to Novel Analgesic Drug Development

Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage.1 Research has also shown that up to 60...

Study Design

Compensating for the Unknown: 3 Keys to Implementing a Successful Decentralized Clinical Trial

In a survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences, 76 percent of respondents indicated that the pandemic hastened their adoption of decentralized clinical trial (DCT) approaches. While the shift to DCTs is well underway, concerns remain around patient monitoring and engagement and data reliability and quality. In particular, nearly half...

Medical and Regulatory Affairs

Dermatology Webinar Series: Looking Ahead to the Future of Dermatology Research

New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research? In this three-part series,...

Medical and Regulatory Affairs

Applied Clinical Trials: The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment Considerations

Gene therapy development is gaining momentum. In 2020 alone, gene therapy attracted $12 billion in global financing through just the first three quarters with more than 370 gene therapy clinical trials underway worldwide.1 The U.S. Food and Drug Administration (FDA) itself predicted it may be approving 10 to 20 gene therapies per year by the...

Patient and Stakeholder Engagement

Applied Clinical Trials: Navigating the New World of Dermatology Trials

Dermatology clinical research is evolving rapidly in response to a regulatory landscape that favors clinical trials that are safer, more justifiable, and less burdensome to study participants. Putting the patient at the center of every phase of the research process — from discovery and preclinical testing to clinical trials and post-marketing studies — can help...

Clinical Research: Phase 1 - Phase 4

Pathways to Expedited Drug Development in the U.S. and Europe

Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient. This webinar will show you where to start and how to envision...

Clinical Research: Phase 1 - Phase 4

Product Development On‑Demand Webinar Series

Planning a product development program? Learn how to set the stage for success with our on-demand webinar series. The steps you take in the earliest stages can profoundly influence your product’s path through development and marketing approval. When is the right time to engage regulators? Which paths to expedited development make sense for your product?...