The draft bill from the House Energy and Commerce Committee, known as 21st Century Cures, calls for a $10bn boost to the NIH’s budget over five years and calls on the commissioner of the FDA and head of NIH to work together on a number of initiatives, including one to create a clinical trial data system “to make de-identified clinical trial data from qualified clinical trials available for purposes of conducting further research.”
The FDA would also be tasked with developing 15 new guidance documents around clinical trials and drug development, including guidance addressing the use of adaptive trial design, and another on the use of Bayesian methods in the development and regulatory review and approval of drugs and biologics.
Similar to an earlier draft, the bill, which has been in the works for over a year, calls on the FDA to incorporate more patient feedback into its evaluation of new drugs and to issue guidance on how it will evaluate a patient's response to drugs.
Additional years of exclusivity for drugmakers, however, were cut from the latest draft and many of the congressmen in a hearing on Thursday seemed pleased that the bill would be less political than previous iterations.
CRO Involvement
A number of the provisions in the bill would also be a boon to CROs (contract research organizations), especially the proposals around creating new trial networks, such as for pediatric trials.
John Lewis, ACRO SVP for Policy, told Outsourcing-Pharma.com the he hopes the NIH will reach out and work with CROs, which in many cases already have established trial networks, and that the NIH doesn’t have to start from scratch.
“Overall, this draft is clearly much more focused than the first discussion draft,” Lewis added, noting that ACRO is focused on three main areas: Modernizing the online database of trials, ClinicalTrials.gov, pushing industry to move to a single IRB (institutional review board) and making some changes to HIPAA to facilitate data sharing and database research.
“As new technologies and applications are developed to facilitate clinical trials, such as the recently introduced Apple ResearchKit, it is imperative that ClinicalTrials.gov be brought up to current standards of technology and usability,” ACRO said in letter to House legislators. “Without a standardized, compatible database, the power of these emerging technologies will never be fully realized and clinical trial recruitment will continue to be one of the major impediments to the faster development and delivery of new treatments and cures to patients.”