Patient Recruitment and Engagement in Neuroscience Studies

Clinical research into neurological diseases is often hindered by a myriad of patient related problems. What can be done to overcome these issues and improve the efficacy of neuroscience trials? In the wake of the pandemic, new opportunities and challenges for neuroscience clinical trials are emerging. After years of slow progress, mental health is now...

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing | Registries and Natural History Studies in Rare Disease Drug Development

Increasing emphasis on rare diseases has led to a greater need to accurately define the profile, characteristics, and outcomes of patients living with those conditions. The development of safe and effective treatments of rare diseases requires a deep understanding of the disease of interest, including its frequency, clinical features, risk factors, outcomes, burden, and evolution....

Product Development

International Clinical Trials | Maximizing Strategic Development for Digital Medicines and Therapeutics

The realm of digital medicine is one that is always moving. As regulatory agencies try to keep up with the changing landscape, how can companies get the best out of new digital medicines and therapeutics? International Clinical Trials, May 2022, pages 18-21. © Samedan Ltd

Clinical Research: Phase 1 - Phase 4

PM360 | New Developments in Gynecological Cancer Research

Substantial unmet needs exist in the diagnosis and treatment of gynecologic cancers. Often, these tumors are detected in later stages when treatment options are limited, and prognosis is poor. However, the gynecologic cancer space is on the cusp of change. The recent introduction of novel medicines, namely targeted therapies, has improved patient care and outcome....

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Commerce: Empowering Patients in Oncology Trials

Patient engagement is critical to the success of oncology clinical trials, many of which have endpoints that require study participants to be followed for many years to evaluate side effects and long-term survival data. And yet, sponsors often postpone careful consideration of strategies for patient engagement and retention until after the treatment phase of their...

Clinical Research: Phase 1 - Phase 4

PharmaLive | Advancing Gene Therapy Development: Key Regulatory and Clinical Trial Considerations

Insights into the human genome have created myriad therapeutic opportunities for previously untreatable diseases. Gene therapy offers promise for addressing unmet medical needs across therapeutic areas and even the potential for curing certain genetically based conditions. As research tools and technology become more sophisticated, gene therapy development is accelerating at an unprecedented pace. According to...

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

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...