US lawmakers propose bill to jumpstart Covid-disrupted clinical trials

While the pandemic has seen coronavirus vaccines and treatments developed and approved at record speed, clinical trials for non-Covid drugs have had to take a backseat. Enrolment in many trials either slowed substantially or was halted last year, while some research sites were forced to close completely. Recent GlobalData research suggests that more than 1,000 clinical trials remain disrupted as a result of the Covid-19 outbreak.

The disruption to non-Covid drug research programmes means that crucial work in areas such as cancer, Alzheimer’s and diabetes has been delayed – and many patients enrolled in or awaiting trials for serious illnesses have been left in the lurch. As the clinical trials ecosystem slowly recovers from the damage wreaked by the pandemic, two lawmakers in the US are pushing for a bill that aims to jumpstart drug research in the country.

The LOANS for Biomedical Research Act, a bipartisan bill introduced last week by Democrat Bobby Rush and Republican Brian Fitzpatrick, would provide funding known as BioBonds to companies and universities conducting FDA-approved clinical trials to identify therapies for unmet medical needs.

Under the act, up to $10m of BioBonds would be issued annually by the US government to researchers from fiscal year 2022 through to 2024. As the legislation requires funding to be paid back regardless of the research project’s success, investors in BioBonds must have long-term, risk-averse capital such as pension funds and insurers – rather than the venture capitalists or pharmaceutical companies typically involved in funding drug trials.

Representative Bobby Rush said in a statement: “The accelerated development of Covid-19 vaccines over the past year has proved that significant investment in medical research and development can speed the development of cures and treatments. Millions of Americans suffering from cancer, Alzheimer’s and other terrible diseases cannot afford to wait for vital treatments and cures while clinical trials are disrupted.

“We must use every federal avenue to restart US biomedical research and ensure that the clinical trials necessary to take basic research to the bedside receive the funding they urgently need.”

The legislation also emphasises the importance of diversity in clinical trials moving forward, urging the Secretary of Health and Human Services to consider funding programmes “conducted by women researchers or researchers who are members of a racial and ethnic minority group or disabled”.

A number of non-profit health organisations have expressed support for the LOANS Act, including the Alzheimer’s Drug Discovery Association, the Foundation Fighting Blindness, the Mark Foundation for Cancer Research, and the Pulmonary Fibrosis Foundation.