MouseHouseApp Blog

The Future of Clinical Trials: Rising Costs

Posted by Jawad Arshad

           The costs of clinical research are increasing due to multiple troubling trends. One of the most prevalent is the expanding cost of research and development for new drugs before they even hit the market. For example, a 2012 article in Nature reported that for every billion dollars spent, the number of new drugs brought to market has decreased by half every nine years for the past fifty years [1]. A major component of this rising cost is the fact that 95% of the experimental medicines are either ineffective or unsafe for general usage. Despite the high failure rate, there is no good way to rule out drugs expect through expensive studies involving animal and human subjects. Even if a drug passes this rigorous testing, its use may not provide greater economic benefits to the companies that produce them or even to the patients themselves. “Most new drugs are only incremental advances,” says Dr. Joel Lexchin, a professor at York University's School of Health Policy and Management, in Toronto, Ontario [2].

Health-Insurance1

 

            A second factor that contributes to the rising costs is the increasing need to collect more clinical data. Newer well-meaning regulations stipulate more through and more prolonged saftey testing during clinical trials. As a result, the clinical trials--especially for drugs attempting to alleviate chronic diseases--tend to be  complex and sometimes prohibitively expensive. There are also increased costs from a greater emphasis on data and site monitoring and the use of expensive technologies such as MRI [3]. It is simply more expensive to meet the necessary data demand. 

           The rising costs have sparked national conversations to find a solution. The National Academy of Sciences has held several meetings to discuss various aspects of the drug research and development pipeline. A recent panel focused on research at the university level and actually suggested that research institutions reimburse federally funded research directly from the money used to support the actual research. The intention was to incentivize the development of technologies that can be commercialized and used to reimburse grant money. The policy, however, would have had the unintended effect of directly lowering the funds available for faculty at any given time which would have made conducting clinical trials even more difficult [4]. Although such a recommendation was made in an attempt to curtail overall research spending which is a priority, there could be multiple other options that would perhaps not be as punitive to researchers.

            Other approaches have succeeded in taming the costs. Progress has been made to attempt to “harmonize” clinical trial standards, which involves collaboration of research teams even in different countries as well as a focus on weeding out drugs that could fail even before they make it to the expensive phase III clinical trials. Furthermore, the actual subjects who are tested in these clinical trials will potentially be screened more thoroughly with a job in their genetic markers to make sure that they can be eligible for the clinical trial. This spending on the back end will allow a more efficient and economical system for drug research in the future.

            At MouseHouse, our goal is to decrease research and development and clinical trials costs by reducing mouse colony size by up to 15%.  The software application eliminates the hassle of using Microsoft Excel as well as paper. Instead the iPad and web application provide labs with the ability to visually and efficiently manage their mice and move forward on major clinical trials. Given that nearly every major drug advance has been predicated on success in trials conducted on laboratory mice, reducing costs of these little mice could help realize large savings. 

 

[1] http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

[2] http://news.sciencemag.org/funding/2012/06/real-cost-research%E2%80%93and-who-pays

[3] http://news.sciencemag.org/funding/2012/06/real-cost-research%E2%80%93and-who-pays

[4] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2630333/

 

 

 

 

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