Introduction There are currently more than a dozen categories of female birth control with proven efficacy on the market. For men, the only options available today are condoms and vasectomy. Despite decades of research and discussion about male contraception, no new products have entered the market since the condom was created in the 1800s. As...
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...
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...
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...
Recruitment for rare disease research has always been difficult due to myriad factors inherent to the low incidence and prevalence of these conditions. In recent years, however, recruiting for rare disease trials has become even more challenging due to increasing competition in the clinical research environment. In addition, as technologies advance and information becomes more...
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...
During the initial planning for clinical trial implementation, intense focus is placed on strategies for patient recruitment, while strategies for patient engagement and retention are often left until after the treatment phase. However, with many current protocol designs in oncology, trial endpoints require study participants to be followed for years to evaluate side effects and...
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...