When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory requirements of a totally female population. Having spent more than 20 years in this space,...
Introduction For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology. It wasn’t until 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. This has resulted in...
WebinarDecember 1511 AM EST Despite the impact on women’s health worldwide, significant unmet needs exist in the diagnosis and treatment of gynecologic cancers. Located in the female reproductive system, many have a reputation for being “silent,” as they are often detected in later stages when treatment options are limited. However, the recent introduction of novel...
TORONTO (PRWEB) OCTOBER 27, 2021 — Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the clinical trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during initial planning, the focus is usually placed predominately on recruitment and not...
Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy...
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...
“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...
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...
The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...
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...