Study Design

Study Design

Premier Insight 279: Executing a Dual-Submission Study

Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires...

Study Design

Premier Insight 280: Engineering a PMA Study

Background Colorectal cancer (CRC) is the second most deadly form of cancer – although it is among the most curable and the easiest to detect in its early stages. The reason: patients notoriously avoid colonoscopy, placing themselves at unnecessary risk. Our client developed a unique solution – a multi-target, noninvasive screening test that could be...

Clinical Research: Phase 1 - Phase 4

PharmaTimes: Parkinson’s Disease and Gene Therapy – Strategic and Operational Considerations

The gene therapy era can be said to have begun in 1990, when the first gene therapy clinical trial took place. Some 3,000 clinical trials have followed that first study, a resounding affirmation of innovators’ increasing recognition of gene therapy’s breakthrough possibilities for treating a diverse range of disorders — especially afflictions with limited or...

Clinical Research: Phase 1 - Phase 4

Drug Development & Delivery: Navigating the Evolving Landscape of Rare Cancer Trials

Rare cancers account for 27% of all new cancer diagnoses in the US and 22% of all new cancer diagnoses in the EU. With the shift toward grouping cancer based on molecular subtypes rather than by location and tissue type, some common cancers are now categorized as groups of rare cancers. For example, melanoma as...

Clinical Research: Phase 1 - Phase 4

Clinical Researcher: Advanced Therapies – Strategies for Success in Clinical Development

Advanced therapy medicinal product (ATMP) development is on the rise. According to the American Society of Gene + Cell Therapy, there were 1,745 gene therapies in development in May 2021, 70% of which were in preclinical studies, and more than 1,300 of these candidates were in development for oncology, the most active therapeutic area. Given...

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...