Expertise: Clinical Development 64 results

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…

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…

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…

“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring…

Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight…

Over the last decade, there has been increasing interest in mobile health (mHealth) and wearables. The general population has been tracking their steps, checking their heart rates, and monitoring their sleep patterns. Meanwhile, the clinical trial industry has been exploring decentralized trials and remote monitoring options as a way of alleviating the travel burden that…