There is growing recognition, among both industry and regulators, that patients are experts in their own illnesses, that they are increasingly well-educated about treatments, and that they want to have a say in how investigative therapies are studied. The concept of patient centricity is very much at the forefront in autologous CAR T-cell therapies because...
Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process. Regularly engaging women, their physicians, and health advocates helps...
According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the study enrollment period, mainly due to difficulties in recruiting...
Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...
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,...
Premier Research · Premier Voices #15: Bringing the Trial to the Patient In recent years, we have seen a shift toward decentralized and hybrid clinical studies that help bring clinical trials to patients and reduce the burden of study participation. COVID-19 accelerated this shift, increasing emphasis on patient access, safety, and engagement. Now, proactively incorporating...
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...
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...
“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...