Study Design

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Decentralized Clinical Trials

Patient centricity—also known as patient-centered care—has been a growing force across healthcare. Like the consumer-driven change in other industries, patient centricity upends established models. Whereas traditionally, healthcare professionals dictate care decisions with little consideration for the patient’s desires, patient-centric care puts the patient first. Its tenets include:  • Empowering patients through technology • Reducing inconvenience...

Clinical Research: Phase 1 - Phase 4

Clinical Researcher: Preparing for the Future

In July 2021, the Industry Standard Research (ISR) Report on Hybrid/Virtual/Decentralized Clinical Trials Market Outlook surveyed 109 industry leaders worldwide who had been involved in DCTs over the past year.{1} Respondents anticipated a 12% increase in hybrid trials over the next two years—and predicted that DCTs would outstrip traditional trial models within three years. They...

Clinical Research: Phase 1 - Phase 4

Premier Insight 278: A Decade-Long Partnership Culminates in FDA Approval

Background Psychiatric conditions are complex, chronic, often debilitating diseases, and there remains a persistent need for novel medications with proven efficacy and safety. Many of the established antipsychotic agents are highly effective but are associated with significant side effects that may negatively impact adherence and patients’ experiences with treatment. Thus, recent research has focused on...

Clinical Research: Phase 1 - Phase 4

Digital Disruption in Dermatology: The Role of mHealth Technologies in Clinical Care and Clinical Research

In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer the convenience of web- or app-based services to in-person assistance. Mobile health (or mHealth) solutions provide increased access to care, making it easier for patients to receive care and for healthcare professionals to deliver that care. Visual assessments...

Clinical Research: Phase 1 - Phase 4

Maximizing Oncology Study Outcomes: Protocol Development Considerations

Minimizing the burden that trial participants experience is essential for successful recruitment and retention, especially in oncology studies, where patients may need to be followed for years after the treatment phase of the trial. For sponsors, the process of optimizing study outcomes involves a deep understanding of the patient’s care journey and a deliberate effort...

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...