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.
Transparency means different things to different segments of the healthcare industry and to consumers themselves. In this blog, a former R.N. and clinical trial participant shares her insights on why clinical trial transparency is so important.
Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.
Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.
CRO helps company overcome early patient screening failure rate of 70 percent as well as assisting with instituting new protocols and renegotiating contracts as the study experiences and major change of direction.
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