“A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.
Can patient recruitment for clinical trials be more efficient with more involvement by patient relations and market access directors?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs have historically been required for good manufacturing practice (GMP) activities, inferring limits at which significant actions must be taken to ensure the manufactured product achieves quality and usability limits.
In 2014, an important dialogue was initiated between big pharma and big academia. The Janssen Pharmaceuticals Companies of J&J, Office of the Chief Medical Officer and the Division of Medical Ethics at NYU School of Medicine partnered to implement an innovative model to support their most important stakeholder — patients.
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.
According to experts, sponsors’ clinical trials websites should focus on three primary areas: patient-centric content and design, navigation and mobile friendliness.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
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This article will provide helpful pointers from Paul Terrill, Director of Strategic Consulting at Cytel to ensure smooth communication between statistical and clinical stakeholders.
Insights into the impact that the shutdown will have on the FDA and on the review of investigational products, including those reviews which were already in process at the time of the shutdown.
IRT professionals can bring together supply chain and clinical team staff for discussions on actual trial needs. Learn how including IRT professionals earlier in the planning phase of clinical trials may result in a better understanding of supply chain needs. This can increase the efficiency of inventory management and lead to unforeseen cost savings over the course of the trial.
Take these steps to create a trusted partnership with your CRO and achieving a much more accurate and financially workable CRO agreement.
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.