INSIDER INSIGHT
Today's Special in Clinical Trials: Risk-Based Monitoring. Have Investigators Been Served?
Eduardo F. Motti, MD Trials & Training Consult
Motti EF. Today’s special in clinical trials: risk-based monitoring. Have investigators been served? Pharm Outsourcing. 2015;16(2): 46-47.
Many readers may agree that Brazil is the country of soccer (until its recent loss to Germany by 7 to 1 in the 2014 World Cup). Brazil's famous association with soccer galvanized after it won the 1958 World Cup in Sweden and introduced 2 phenomenal players: Pelé and Garrincha. The latter did not become as internationally famous as Pelé, but he was a soccer genius, too, in spite of several significant physical and intellectual limitations. True or not, the story says that just before the match between Brazil and Russia in 1958, the coach gave Garrincha some complicated instructions on how he wanted the player to dribble several adversaries, go deep, then turn to the middle, and shoot on goal. Garrincha listened with concern and asked naively, "Have you set this up with the Russians already?"
I think we are acting like the Brazilian coach as far as the risk-based monitoring (RBM) of clinical trials is concerned. The industry is deciding the moves and plays, but has not set them up with the investigators yet.
RBM is a perfect fit to the current scenario of clinical research for a number of reasons. First, costs of clinical research have risen dramatically in the last years, and the industry is doing whatever is possible to curb them. Second, the study monitoring process, although absolutely necessary, is considered highly inefficient, labor-intensive, and tedious. Third, technology has matured to the point that any clinical information collected from a study participant may be entered into the study database in almost real time, be checked for consistency and protocol adequacy, and statistically analyzed, allowing a protocol manager sitting in headquarters to detect failures and trends before everyone else. Fourth, investigators and research sites are currently treated as service providers, and quality services are mandatory.
The cost of developing a new pharmaceutical product has risen to 2.5 billion dollars, according to the last calculations published by the Tufts Center for the Study of Drug Development (available at
http://www.csdd.tufts.edu/). Fifty-six percent are spent in clinical development. In a report from the same group published in 2002, the number was 800 million.1
So, since RBM Eduardo F. Motti is the managing partner of Trials & Training Consult
(
http://www.trialsntraning.com). He has over 25 years of experience in big pharma and CROs, working in clinical development and clinical operations roles in Brazil and Latin America.
was proposed, R&D finance saw the chance for big savings in monitoring labor, travels, cycle time reduction, etc. As a matter of fact, initial analysis of projects using RBM have found reductions in monitoring expenses around 25%,2
although further confirmation is pending. Pharmaceutical Outsourcing | 46 | March/April 2015
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