Study Design

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...

Clinical Research: Phase 1 - Phase 4

Premier Insight 282 | Leveraging the Power of Communication: Supporting Enrollment of a Phase 2 Cervical Cancer Study During a Pandemic

Background Cervical cancer is the fourth most common cancer in women. Despite being highly preventable, over 600,000 women were diagnosed and more than 340,000 died from the disease worldwide in 2020. The majority of cervical cancers are caused by infection with human papillomavirus (HPV) and the implementation of HPV vaccines has been shown to reduce...

Clinical Research: Phase 1 - Phase 4

Patient Enrollment and Retention: Overcoming Challenges in Observational Research

The challenge of enrollment for observational research Patient enrollment and retention for investigational trials are notoriously difficult. How is enrollment affected when there is no direct benefit to the patient: no breakthrough study drug with the potential to cure, no added caregiver time, no meaningful compensation for participating? Observational studies, by design, demand a continuation...

Clinical Research: Phase 1 - Phase 4

Designing and Conducting Decentralized Dermatology Trials

August 25th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT Conducting rigorous assessments and obtaining the highest-quality data are essential to dermatology clinical research. Traditional clinical trial designs can pose obstacles for patients with busy work and personal lives, especially if they live far from a study site. Decentralized trials open opportunities...

Clinical Research: Phase 1 - Phase 4

Addressing the Top 7 Challenges in Decentralized Dermatology Trials

Each year, nearly 85 million Americans see a physician for at least one skin disease, with $75 billion in direct costs to the U.S. healthcare system.[i] While the FDA has approved more than 110 dermatology drugs, these treatments address only about 30 indications, leaving the vast majority of known skin conditions unaddressed. In recent years,...

Clinical Research: Phase 1 - Phase 4

Full Service or FSP? How to Choose the Right Model for Your Study

Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for...

Clinical Research: Phase 1 - Phase 4

7 Tips for Designing and Operationalizing Rare Disease Natural History Studies

Natural history studies play a crucial role in rare disease drug development, providing insights that advance discovery and shape clinical trial design. The benefits of these studies also extend to understanding patient journeys, clarifying the standard of care, identifying disease-specific centers of excellence, and surfacing opportunities to improve patient care. In this blog post, we...

Clinical Research: Phase 1 - Phase 4

How to Use Patient Registries and Natural History Studies in Rare Disease Development

Successful drug development requires a deep understanding of the disease of interest—its etiology, epidemiology, presentation, manifestations, and progression. In rare diseases, however, much of this information may be unknown. Patient populations are small and historical data are collected inconsistently and dispersed across treating physicians practicing in diverse geographies. Patient registries and natural history studies are...

Clinical Research: Phase 1 - Phase 4

5 Tips for Operationalizing Gene Therapy Studies

Gene therapy clinical trials are logistically complex studies that require highly qualified sites and engaged patients for success. The ability to select the right sites and patients can be the difference between product failure and market approval. In this final part of a three-part blog series on gene therapy development, we provide tips on operationalizing...

Clinical Research: Phase 1 - Phase 4

Designing Robust Gene Therapy Studies

To develop a successful gene therapy, sponsors must conduct research studies that balance the need for safety oversight and robust clinical evidence with the challenges of finding the right patients, pairing them with qualified sites, providing informed consent, and confirming they are capable of — and committed to — fulfilling all protocol requirements.    In...