March 23, 2022 | 10:00 AM EST / 7:00 AM PST / 3:00 PM GMT With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As...
Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to success. Fortunately, many of those barriers can easily be avoided. In more than 30 years...
March 3, 2022 | 2:00pm AEDT Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...
Heavy menstrual bleeding (HMB) is one of the most common gynecologic disorders among women of reproductive age, accounting for up to one-third of all gynecologic office visits.1 HMB refers to bleeding associated with regular ovulatory cycles and involves blood loss greater than 80 ml per month. It is a subcategory of abnormal uterine bleeding (AUB),...
Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Topics in this...
Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many Phase 2 trials fail to...
Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually placed predominately on recruitment and not on patient...
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...
February 24, 2022 | 10:00am EST Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...
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...