2006 –Near Term Expectations for Clinical Research

By: Brian S. Robinson
 i3, Vice-President, Global Marketing
 www.i3global.com

There is little mystery about what the next few years hold for the clinical research industry –it comes down to one word: speed. It is all about speed. The gauntlet has been thrown down and the companies that are able to demonstrate an effective and consistent approach to truncating the timeline of clinical trials will be very successful.

Speed is not a capability, though it has been stated by some as such. Speed in clinical trials is the result of four competencies that are shared by all involved with the project: quality, scientific expertise, operational expertise and technology.

Quality comes first in the list as it is the tie that binds. Technology, scientific and operational expertise are also critically important but without quality, timelines will suffer, regardless of the investment in the other areas. Looking ahead it is safe to predict that more sponsors and CROs will place a greater emphasis on and make more significant investments in quality. The organizations that embody quality as something more than a  “program” and are willing to make the investment, will realize with their partners, the positive impact in the form of timely recruitment, fewer queries and faster database locks to name just a few key metrics that can demonstrate speed.

Scientific and operational expertise have long been sought as key drivers of a successful trial. The challenge has been that many companies have simply been too diversified and lack true depth of category and situational expertise. The CROs that provide a strong balance of sizeable global resources and therapeutic expertise will continue to make the best partners.

So much has been written about technology –virtually each month an industry publication has a cover story on EDC. To this end I will not re-state what is known; EDC, along with other advances in technology, holds incredible promise to increase the speed and efficiency of clinical trials. The key will be for new advances to effectively plug into the existing system and not look to dynamically change processes.  As we’ve seen with EDC, adoption of new technology in clinical research is a long road.