Continuing efforts to increase visibility into the clinical trial process have resulted in a number of proposed and final regulations, guidance documents, and principles for the sharing of both study-level and patient-level clinical data. In this webinar, industry leaders will review the current content and status of the different requirements and recommendations for data-sharing from the EMEA, FDA and PhRMA. This review will assist attendees in determining the necessary steps to navigate through the complicated field of data transparency and to assure compliance.
Other content in this Stream
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
The impact of participant payments on clinical trial recruitment.
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research.” Explore the history and motivation that led to Dr. Beecher’s ground-breaking paper.
Learn about the regulatory framework that governs the use of investigational drugs outside clinical trials (formerly called “compassionate use”), and the ethical challenges surrounding it.