Addressing the Most Common Causes of Late-Stage Clinical Trial Failures and Preventive Measures which Greatly Increase Trial Success Rate

This clinical compliance training will focus on the most common causes of late-stage clinical trial failures along with measures that can be taken during trial development to greatly reduce the risk of these failures. Attendees will learn the best practices for increasing trial success rates.

Why Should You Attend:

While only 10 in 10,000 investigational drugs make it out of the laboratory and into human trials, only three to four of those 10 make it out of Phase 1 trials, and only one in four late-stage clinical trials end with a successful result and a marketed product. With the cost of development so high, there are procedures that can be used to minimize the rate of late-stage trial failure. Only a third of late-stage clinical trial failures throughout the industry can be attributed to the investigational product itself not working as expected. However, two-thirds of the failures can be attributed to other causes.

Many investigational products are discontinued and smaller companies close simply because these common causes of trial failures are not addressed upfront and issues detected and resolved early on in the clinical trial process. Late-stage clinical trial success rates of approximately 75% can be achieved by applying various development, operational, quality and biostatistical procedures which have proven to work for many dozens of late-stage clinical trials in a variety of therapeutic areas.

During this webinar the instructor will present a list of the most common crucial issues to address prior to study start to help ensure success of your late-stage clinical trial.

Areas Covered in the Webinar:

• The most commonly overlooked items that drive late-stage clinical trial success or failure.
• Methods to address each of the critically overlooked items prior to and during study conduct.
• Risk of late-stage trial failure using various preventive and correction action methods.
• Cost of implementation or not implementing various preventive and correction action methods.
• Technologies and processes available to minimize trial risk.
• Actual examples in a variety of therapeutic areas before and after these processes are employed.
• Methods to rescue studies using the processes discussed.

Who will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Clinical Operations within the pharmaceutical, medical device or diagnostics clinical
• Business Development
• All personnel within the company with an interest of having successful clinical trial outcomes

Instructor Profile:

Dr. Adam Ruskin, PhD, DVM, MPH is the founder of LabCRO, Inc., one of California's largest Clinical Research Organizations. Dr. Ruskin was a researcher at the Centers for Disease Control (CDC), an FDA Advisor, and two-time TEDMED award nominee for innovation. He is the creator of LabTracker, the industry's first system for tracking clinical trial samples from the time of patient sampling until result posting. He has lead all clinical, data management and biostatistics activities at 4 successful start-up pharmaceutical, biotech, and medical device and diagnostics companies, and now leads successful clinical and data management teams for his clients through LabCRO. As a leading industry speaker for over 20 years, he knows the details of what it takes to get investigational products approved, especially under required budgets and timelines of most companies.