House Energy & Commerce chairman Fred Upton (R-MI) and Rep. Diana Degette (D-CO) earlier this week unveiled broad goals of what they’re calling a 21st Century Cures draft bill they’re working to introduce later this month.
Upton and Degette are calling to modernize clinical trials to streamline the approval of drugs and devices, which will include speeding up the processing of paperwork related to conducting trials, as well as making it easier to recruit patients or adapt trials as new information comes to light.
“Technologies like genetic screening can help us target the right treatments to the right group of patients, creating opportunities for smaller, more targeted and effective trials,” Upton and Degette write.
John Lewis, EVP of ACRO (Association of Clinical Research Organizations), told Outsourcing-Pharma.com: “We have certainly spent time with E&C [Energy and Commerce] staff to work on this to provide our perspective and in some cases some technical advice.” He added that identifying some of the problems and roadblocks in research is “relatively easy but actually working through legislative proposals to fix them is difficult because there are limitations on what Congress can actually do.”
A lot of the conversations have been around issues like improving the IRB process, which NIH has been upfront about its desire to reform, and improve the US clinical trials database -- clinicaltrials.gov – to make it more standardized and easier to search, as well as more useful for patients and physicians.
“With NIH essentially mandating the use of a single IRB that may really open the doors for other research entities on the commercial side to follow the same practice,” Lewis said. “The other area that’s more technical was around the idea of data sharing and roadblocks for sharing data – some of that involves modifications to HIPAA [Health Insurance Portability and Accountability Act] that would really help facilitate research on the outcomes side.”
HIPAA changes are gaining ground with the patient community, as well, Lewis added, noting that “survey after survey shows patients are willing to share data for research purposes and we shouldn’t stand in the way of that.”
Other Initiatives
The congressmen are also looking to better integrate the patient perspective into the regulatory process.
“New public-private partnerships that can help build the science around biomarkers and patient-reported outcomes are one way to produce more collaboration, move toward faster cures and better involve patients,” they write. “We also will create a predictable process for the qualification of biomarkers and patient-reported outcomes so we can utilize these tools in the development process.”
A recently released study found that CROs are increasingly adopting electronic means by which patients can report their outcomes.
The congressmen are also looking to share more genomic and other clinical data to help “foster more collaboration among researchers,” they said. In addition, they’re hoping to further “invest in the future of science” by helping young, emerging scientists with expanded access to resources and federal dollars.
“Many of our most promising investigators -- many with great ideas and cutting edge training -- are hamstrung by the challenges of securing much-needed support. We will encourage them to conduct research here in the United States, creating jobs and ensuring that patients here at home have access to the most innovative, new treatments,” they added.
The congressmen also may dabble into how the FDA brings innovative drugs to market as they’re also calling to further incentivize new drugs and devices for unmet medical needs.
“This includes streamlining the premarket process while establishing mechanisms to better capture real world evidence post-market. We can also examine incentives, such as exclusivity or simplifying the reimbursement process, to produce drugs and devices for diseases with unmet needs,” they write.