As the coronavirus pandemic rapidly upends everyday life, there is growing concern that it is disrupting the pipeline for new cancer drug development: clinical trials.
Without data from pivotal clinical trials, new drug filings will be delayed, which means some important new medicines will take longer to reach the market, reports STAT. Clinical trials also play a key role in treatment options for people with cancer long before new drugs are approved by the Food and Drug Administration (FDA), offering access to experimental treatments for individuals when currently available FDA-approved options are no longer working for them.
To help keep research on track in the face of such uncertainty, the FDA has offered researchers guidance on how to manage the disruption to clinical trials that they might experience as a result of the pandemic, BioPharma Drive reports.
Phase I trials, including those for cancer treatments, could prove particularly susceptible to such disruption, since they typically require participants to make in-person visits to clinical settings, Fierce Biotech reports. Participants may now be reluctant to attend such visits due to concerns over contracting the novel coronavirus that can cause the disease COVID-19.
Biotech companies Prevention Bio, Addex Therapeutics, Arrowhead Pharmaceuticals and Iveric Bio have recently indicated that their clinical trials have indeed been delayed because of the new pandemic. More are expected to make similar announcements in the new future.
Following on the heels of the National Institutes of Health’s (NIH) new guidelines for NIH-backed studies in humans, the FDA has issued guidance that allows investigators conducting clinical trials a certain amount of flexibility, including the modification of research protocols, while they navigate the new and uncertain world that the coronavirus has engendered.
Investigators are advised to maintain rigorous documentation of their trials and to communicate effectively with participants, the FDA and any of their review boards if they need to make changes as a result of the coronavirus disruption. Such documentation can help the FDA account, for example, for any missing data in investigators’ ultimate submissions to the agency should they seek approval for a new treatment.
Among the potential disruptive factors, the FDA noted, are the closure of research sites, quarantines, limitations on travel, problems with supply chains and coronavirus infections and among clinical trial staffers.
As a potential work-around in the event that face-to-face meetings with participants are prohibited, the FDA suggests that investigators pause their recruitments for clinical trials, monitor participants at a reduced schedule or communicate with them virtually.
If necessary, investigators may be compelled to take participants off certain experimental treatments, should the risk of keeping them on the treatment in the face of the coronavirus-related disruptions appear greater than that of discontinuing their therapy.
Check out a Cancer Health article on what people with cancer need to know about the novel coronavirus and COVID-19 by clicking here.
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To learn more about clinical cancer trials, click here.
To read the BioPharma Dive article, click here.
To read the Fierce Biotech article, click here.