Approaches to Address the Impact of Increasingly Complex Clinical Trials

Pam Atwell, Director, Operational Strategy & Planning, Clinical Development Services, COVANCE INC .
William D. O’Riordan, MD, Medical Director, eSTUDYSITE

Ensure patients safety is the most important part of the trial. The current state of affairs in clinical trials is that an overwhelming 92% behind enrollment timelines. Trial delays have impact on the registrations of the products. What have we seen over the past few years? We’re looking for patients in nontraditional countries, we’re chasing patients where they haven’t been tapped into in the past. Even though they exist, we’re waiting for investigators to catch up to the demand to give us access to the patients. With out and investigator site, we can’t get patients enrolled in our clinical trials. In India, 2% of the global investigator pool in 2007. China didn’t approach 1% of the pool. Investigators are small percentage at the moment, top 20 growth rates are all in emerging markets: China, Estonia, Russia, Peru. We have not only more complex studies, but we also have more of them, with few investigators for find patients.

What does this mean for the emerging markets? Investigator sites aren’t in place and the protocols are very complex. Will we see the same churn rate as we see in the western countries? Research for a year and then dropping off?

FMEA – Processes Failure Mode & Effects Analysis (FMEA) Systemized group of activities to identify the mission failures and their impacts. It was developed by the US government. Covance has applied this to clinical trial management. The steps that have been identified for potential failures or places that failures could occur on a clinical trial. We can identify possible places to identify failure at a site. Pick up on the places for protocol deviation and violations that occur. You can then rank your failures. Risk score for all potential failures.

What are the barriers to success? Lack of fundamental understanding of the nature of risk management, Up-front planning requires initially more time and cost, ongoing review processes also require additional resources, appears to add complexity, and cultural change in how many clinical trials are currently conducted.

William – Proactive method of addressing as far as the concerns of the research sides. Average increase of CRF pages went from 55 in 1999 to 180 in 2006. Compensation per procedure has decrease 7.9%. Pharma must plan ahead better and better to proactively manage trials.

Covance has two committees:
Protocol review committee to examine proposed protocol, each member of panel has specific task to overlook. The committee reconvenes in one week and reports on the areas they were designed. They then decide whether or not to take the protocol. This must be done very early on.

Fast Start Committee is in charge of coordinating and implementing and protocol and addressing and solving complex issues contained in the new protocol.

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