Moving Beyond 10 Steps To Clinical Study Startup

Until recently, the study startup portion of clinical trials has not benefited from innovation, essentially remaining manual or heavily rooted in Excel spreadsheets, causing this complex process to seriously underperform. The 10 steps to clinical study startup eBook, based on the directives in ICH E6(R1), helped define the site-specific activities at the outset of a clinical trial and to this day remains a very popular download.

Today, study startup functions and job roles are more commonplace at sponsor and CRO organizations, but despite this, clinical operations teams are drowning in data but starving for information at a time of intense pressure to speed up clinical trials and restrain costs.

The average cost of drug R&D is now estimated to be $2.9B by Tufts CSDD — this is unsustainable. Globalization (multi-country studies), the changing regulatory landscape (ICH E6(R2)/(R3), EU 536/2014, etc.), matrix organizational changes and non-traditional trial designs (e.g., decentralized clinical trials) have forced the industry to rethink their approach to study startup. These traditional steps need to be expanded upon, collapsed and fit for purpose. But, how?

In this webinar, featured speakers will explore:

• Understanding the operationalization of ICH E6(R1)
• The limitations of only 10 steps in multi-site and multi-country trials
• Why the 10 steps will not solve the current $2.9B problem or align with ICH E6(R3) efficiency objectives
• The benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol
• How new techniques and technology (e.g., quality by design, parallelization, machine learning, etc.) can help improve the operational efficiencies of study startup