For patients battling rare cancers, especially 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.
How to employ processes that take an upfront approach to preventing or mitigating problems associated with document completion.
In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).
Gene editing technology is a rapidly evolving area of clinical and translational research that combines the potential of great advances with profound ethical challenges. Join Medpace medical and regulatory experts to discuss the unique opportunity of this evolving technology as it applies to human diseases.
Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.
A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS) after an incumbent CRO was not meeting enrollment expectations. Read how Biorasi’s project management-first approach allowed rapid feasibility and site startup to meet critical deadlines.
As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
Along with a fear of a low ROI, pharmaceutical companies have been hesitant to take on rare disease drug development because the indications can be challenging to study. Although each rare disease is unique, some elements of the clinical operations of rare disease trials are consistent across indications. Here are some common challenges experienced during the course of researching rare diseases.
Health Decisions is a full-service CRO specializing in clinical studies of therapeutics for women’s health indications and studies of diagnostics for all therapeutic areas.
Cytel is committed to improving the quality, analysis and interpretation of data for clinical development. Founded by world-renowned biostatisticians and Fellows of the American Statistical Association, Cytel maintains a tradition of leadership in statistical innovation. Our team is dedicated to improving the probability of clinical trial success and helping to deliver new medicines to the patients who need them.
Oracle Health Sciences Trial Management and Monitoring Cloud Service is an integrated, purpose-built trial planning and management solution for today’s complex trial environment.
Bringing the patient’s perspective into all phases of development.
Trial design, site selection and recruitment, all tailored to the specific oncology indication. It’s what we do. Best.