First up is S:3506, a Bill introduced in the US Senate last week that seeks to eliminate duplicate clinical trials if such testing is inconsistent with "ethical norms."
Full details have not yet been published, however the brief outline that is available suggests sponsor, Senator Bernard Sanders, wants to change the rules requiring multiple assessments for drugs, vaccines, biological products and medical devices.
The Bill was introduced on August 2 and referred to Senate committee, which in turn sent it to the Committee on Health, Education, Labor, and Pensions.
Outsourcing-pharma.com will track the progress – or otherwise – of Bill 3506 and keep you informed.
Clinical trial registration
Meanwhile, in the US House of Representatives another Bill potentially impacting the contract research sector - HR 6272 – has been introduced.
The Bill – named the Test Act and introduced by Congressman Edward Markey (D-Mass.) on August 2 – seeks to update the Clinicaltrials.gov registry to ensure that all human studies are recorded and that results are reported.
Specifically, the Bill calls for:
• All interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial.
• Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial.
• Provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use
• Instruct the Secretary of HHS to undergo a rulemaking to require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database
• Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements.
In a press statement Markey said: “If we were issuing a grade on the clinical trials report card, it would be Incomplete” adding that “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.
“Significant strides have been made since we established this registry in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials.
“Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk. I look forward to working with my colleagues on this legislation.”
Similar comments were made by Henry Waxman, ranking Member of the Energy and Commerce Committee, who said that while the introduction of the database in 2007 was a significant step, there is still work left to do.
“Companies are no longer able to hide negative study results, while emphasizing the positive ones. But there is more to do. This legislation [HR 6272] will bring to light critical additional information about clinical trials that companies are not currently required to disclose.
“It also clarifies that all clinical trials used to support an application for product approvals in the U.S. are subject to the database requirements, even if those trials are conducted abroad.”