Advanced Clinical attended the DIA conference June 13-17th, 2010 in downtown DC at the Washington Convention Center. It was an awesome week. We were able to meet so many people, while networking, brainstorming, and discussing numerous topics surrounding the clinical and pharmaceutical industry.
Our team was able to sit in on and discuss many interesting presentations. The one presentation that really hit it for us was the session “Fiscally Responsible Protocol Development: Minimizing Potholes and Avoiding Sinkholes” hosted by Anna Hindle, Anne Cropp and Ken Getz. The session outlined:
a) The financial impact of protocol amendments including the hidden costs
b) Protocol amendments correlation with therapeutic areas and functional areas, e.g., data management, clinical operations, etc.
c) Triggers/causes of protocol amendments
d) Characteristics of protocols that generate lots of amendments, e.g., the more Investigator sites, the more amendments
e) Amendments that are avoidable and amendments that are not avoidable
f) Lessons learned and tips / techniques for circumventing / preventing the avoidable amendments
Some interesting facts about amendments we learned: 40% of amendments occur before the first patient is in, 631 hours/amendment approval, 484 hours/amendment to implement, and a minimum of $60K per amendment - $400K per amendment. We also learned that the key triggers of amendments were due to: standard of care changes, safety issues, and the need to deal with sub-populations.
Advanced Clinical had some additional thoughts on the amendment front upon reflecting on this presentation:
a) Would be good to determine the characteristics of a good amendment and a “bad amendment”
b) It’s important to perform the analysis of doing the amendment vs. not doing the amendment
c) Perhaps consider the following items to deal with amendments more efficiently:
- Think about doing amendments in “release” schedules like people do in software development
- Use tools that allow standard language document components – there are some good document management tools that have this functionality
- Create guidelines for the organization to evaluate whether or not an amendment should be performed
- Understand the causes of amendments in your organization. Gather data around amendments for therapeutic area; cause; sub-population; hours to design/gain approval for amendment; hours to implement amendment
- Create an ecosystem of experts to review the protocol before finalizing it to avoid amendments. Put more time into the protocol up front to ensure completeness and consideration of key areas where changes could occur
- Make the language more flexible in the protocol to avoid the amendment, e.g., put in “5-9 sites” instead of “7 sites”
On top of the presentations, the exhibitions were excellent. Our favorite was Oracle’s demonstration of their new Oracle Clinical product. We were able to talk with Oracle and their product roadmap as it relates to their EDC product, “RDC”. Also we were able to discuss Oracle Clinical’s “big picture architecture including IVRS, IWRS, EDC, Business intelligence as well as the anchor Oracle Clinical Product.
Were there any presentations or exhibitions you particularly enjoyed or thought was informational? What are some of your thoughts on the presentations given? Hanging questions? Comments? Please let us know! Come join our discussion and comment or write on our wall in our Blog or on our Facebook page. We’d love to hear your ideas and takeaways from the DIA Conference.
AC also had the opportunity to host OYA for a networking happy hour. It was a huge success! We were able to gather so many great people from the DIA Conference. There was a lot of relaxing, socializing and brainstorming for advancing discoveries. If you weren’t able to make it, please join our discussion for Advancing Discoveries on our Facebook page at www.facebook.com/AdvClinical
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