A Review of ICH E8 (R1) General Considerations for Clinical Trials

The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.

Achieving Global Health Equity Through More Diverse and Inclusive Trials

Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.

Ensuring Quality in Fast Enrolling Trials

Are new trials coming at you with break-neck speed? This webinar reviews a case study from a fast-enrolling trial and offers strategies for maintaining high quality standards and recognizing and mitigating the risks of accelerated enrollment.