The 21st Century Cures Act was recently passed, which aims to assist in the modernization of clinical trials to help bring new treatments to patients in need. The legislation calls for enhancements to clinicaltrials.gov that will make the site more useful for patients and their physicians, streamlined institutional review board processes, promotion of data sharing and incorporation of real-world data into the research process, greater focus on patient-centered drug development, and increased funding for the FDA.
 
John J. Lewis, Senior Vice President, Policy & Public Affairs at the Association of Clinical Research Organizations (ACRO) discusses the key takeaways from the passage of the 21st Century Cures Act. –KB
 
Contract Pharma: What are the key takeaways from the passage of the 21st Century Cures Act?
 
John Lewis: One key takeaway is that Congress actually can work together in a bipartisan fashion toward a common objective, like Cures. In this case, it required some tradeoffs such as eliminating many incentives and patent extensions for pharma companies, which were in the early versions of the legislation, while increasing NIH funding. Also, many of the ideas promoted in Cures are already being pursued by the CRO and the biopharma industries.
 
More specifically, ACRO was very pleased to see the broad recognition of the importance of clinical trials with an emphasis on how the process can be improved through the regulatory regime at FDA, increased use of data sharing and “real world” data, and the incorporation of scientific advances like biomarkers and other surrogate endpoints into the clinical trials process. We were also pleased to see the acknowledgment that the FDA will need additional resources to implement many of these provisions. And clearly patient-centered drug development is the new paradigm. 
 
CP: How will it impact drug development and Pharma/Biopharma and CROs?
 
JL: We’re not sure there is anything revolutionary in this legislation – or necessarily that there should be – but rather a series of incremental changes that, taken together, can have a significant impact on the time and cost of drug development. ACRO focused on three areas that we believe will lead to greater efficiency in the development process. First, clinicaltrials.gov needs to be upgraded to be more usable for patients and investigators with the longer-term vision of having the database integrated with EHRs to generate awareness of clinical trials that might be appropriate for the patient and to facilitate patient recruitment.
 
Second, we believe moving to a central IRB system for multicenter clinical trials can slice a significant amount of time from the development process. Finally, survey after survey shows that patients are willing to share their data for research purposes and the bill contains necessary changes to HIPAA that would enable this while maintaining appropriate privacy protections.
 
CP: How will the Cures Act impact review processes and data sharing?
 
JL: There are several provisions in the bill that would encourage the FDA to look at “real world” data in the review process. ACRO supports this as long as the FDA is provided the autonomy to determine the appropriate uses of the data. For instance, we do not think, at this point, an approved drug could be approved for an additional indication on the basis of real world data alone, but this evidence could certainly be incorporated into the review process. In terms of data sharing, entities can currently share data for treatment, payment or operations and the Cures bill simply extends this allowable data sharing for research purposes as well. It makes no sense to silo data off from research.
 
CP: In what other areas is ACRO working with the Government on?
 
JL: We will be working with the Senate on its version of Cures as they ramp up their discussions with a target of having a bill by Thanksgiving. Other than Cures, ACRO’s primary legislative focus in the U.S. is a campaign to extend the benefits of the R&D tax credit to CROs. CROs benefit from the R&D credit in the UK, France, Canada and elsewhere but not in the U.S. under current law. With the CRO industry accounting for more than half of clinical research globally, we believe this places the U.S. at a competitive disadvantage and jeopardizes innovation here.