Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.
IN 2018 there were many changes, trends, regulations and priorities that shaped the direction of the clinical research and drug development fields. In this paper, WCG experts share what they anticipate in 2019, and what everyone should be prepared for as we approach another year of change.
Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.
Adaptive design strategies have been especially useful for rare disease research in general and rare oncology in particular. Read more to see how the savvy application of adaptive trial design compares to conventional study designs.
For patients battling rare cancers, especiall those lacking standard treatments, they don’t have the time to wait for more concrete measures. In these cases, choosing the appropriate endpoint for a trial is crucial. Read on for a rundown of the five major types of clinical endpoints in rare oncology and the best way to use them.
According to experts, sponsors’ clinical trials websites should focus on three primary areas: patient-centric content and design, navigation and mobile friendliness.
See how a dedicated clinical trials website can provide important study information to patients, caregivers, healthcare providers and researchers — as well as boost recruitment.
Whether your organization lacks formal disclosure policies and procedures, or has longstanding SOPs in place, the best way to gauge the effectiveness of your clinical trial disclosure process is via a third-party assessment.
This webinar highlights how through better planning and early engagement with experienced IRT specialists, you can reduce the risk, time and resources spent on your clinical trial.
This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
This webinar highlights the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process.
This webinar reviews the current state of technology in gene therapeutics and examines trends in immuno-oncology and gene therapy for hematological malignancies.
Sharp has been a leader in blister packaging for pharmaceutical products for more than 50 years. We are renowned for our extensive experience, expertise and capabilities, as well as for having the largest assembly of cutting-edge form, fill and seal equipment in the industry.
With pressure to get products to market and meet corporate targets, it’s understandable that the returns and destruction elements of clinical trials are often something of an afterthought.
Our analytical and research services evaluate the performance of formulations using a whole range of advanced investigative testing procedures. They’re a hugely important part of our work, forming a valuable foundation for future developments and innovations.