The UK's Academy of Medical Sciences says that in order for stratified medicine to achieve its potential as a method for personalizing drug and diagnostic research, trials and treatment, several challenges posed by the regulatory environment, health economics, and the capabilities of clinical and research infrastructure need to be addressed.
AMS says in a new report, "Realizing the Potential of Stratified Medicine," that because of these challenges these types of stratified and personalized medicine and research are not being implemented quickly enough.
The academy calls for more genomics research, better biomarker resources, and better data handling and analysis tools, among other proposals.
Rather than focusing on the obstructions, the report offers several recommendations that AMS believes could help ease along the arrival and uptake of the stratified medicine.
Pricing is one issue the academy flags. There has to be better flexibility in pricing for stratified medicine products p both for the diagnostics and the associated therapy, to ensure cost-effectiveness while encouraging innovation, AMS says.
There also is too much variation in regulations, according to AMS, and it wants to see better coordination and cooperation between therapeutic and diagnostic regulators that "balance the need for robust proof of safety and evidence to support clinical value."
AMS says there should be a continued emphasis on research to understand the genetic and molecular bases of diseases; more development and use of new informatics technologies; improvements and standardization of clinical data collection and the linkage of that data with genomic databases; more tissue collection for biomarker research, and the organization of those tissues into large-scale biobanks; and it sees a need for more efficiency and productivity in the development of therapeutics and diagnostics.