When asked how these revisions will impact the NIH and the transparency of NIH-funded research, a spokeswoman told us that the agency does not comment on pending legislation. Currently, PIs (principal investigators) and funding recipient institutions are expected to make the results and accomplishments of their activities available to the research community and to the public at large.
The new bill would still increase NIH funding by about $8.75bn over the next five years, which compares with $10bn that the House Committee on Energy and Commerce unanimously passed in May.
And provisions that might impact CROs (contract research organizations) -- such as the establishment of a national pediatric research network, the standardization of inclusion and exclusion criteria across ClinicalTrials.Gov, or encouraging the use of master protocols to speed drug development – are still included in the bill.
Also included in the revised bill are new requirements for the FDA, particularly related to issuing new guidance that could eventually impact CROs, such as guidance assisting sponsors in incorporating adaptive designs and Bayesian statistical modeling into proposed clinical protocols and applications.
The revisions followed estimates from the Congressional Budget Office (CBO) last week that say implementing the bill would cost $106.4bn between 2016 and 2020, and would reduce direct spending, on net, by $11.9bn over the period of 2016 to 2025.
Advocates for the bill, however, say that entitlement changes will lead to billions in additional savings in Medicare and Medicaid in the second decade and beyond, which are not quantified by the CBO. House Energy and Commerce staff also calculated that the permanent entitlement reforms in 21st Century Cures will cut federal spending by an additional $7bn in the second decade following the act’s implementation.
Included in that cost of implementation would be $6m for the FDA to establish a pilot program to create a research sharing system, in coordination with NIH, which would give third parties direct access to data generated from government-funded clinical trials and would assist NIH with standardizing certain information related to eligibility for clinical trials.
House Majority Leader Kevin McCarthy (R-CA) said the House will consider the 21st Century Cures Act sometime later this week. The House Committee on Rules will meet to discuss the revised bill Wednesday while amendments to the legislation are expected to be filed by today.