Emergency plan based on historic precedent
In early April, the US Food and Drug Administration (FDA) determined a course of action they called the Coronavirus Treatment Acceleration Program (CTAP). This special emergency program is designed to speed up the regulatory processes for all SARS-CoV-2 research without compromising safety. The intent is to get any promising treatments, vaccines, or ancillary products related to COVID-19 out to patients as quickly as possible.
Although the current crisis is unique, the framework for CTAP is based on historical precedent – namely, the AIDS crisis. In the 1980’s HIV was spreading rapidly through interpersonal contact and through the blood supply. With AIDS patients frantic over the lack of treatments, the FDA set up a special task force to handle the rush of Investigational New Drug Applications (INDs) for potential AIDS treatments. They adopted a new outreach program, which they termed pre-IND consultation, to help take the guesswork out of streamlining accelerated approaches to IND starts.
Now, like then, the FDA is putting out notices asking people to accelerate pre-IND requests, promising to triage these quickly and offering quick feedback in order to best minimize the pre-IND research. This new program is called CTAP.
The first step of acceleration is marking all requests sent to COVID19email@example.com for immediate review. Requests will be given top priority and sent to the appropriate FDA personnel for evaluation. According to the website, requests will be judged on “scientific merits, stage of development, and identification as a possible priority product.”
It’s understood that for totally new drugs that have never been used before, few shortcuts can be taken. Unlike cases of rare diseases or other immediate life-threatening cases, the people enrolling in COVID-19 clinical trials (Phase I) are typically healthy volunteers. For those people, all safety and efficacy studies will need to be run to prevent harm to the volunteers.
In contrast, if there is a drug that has been previously developed for another indication, or has known antiviral activity that cross-applies to COVID-19 and can be used in an emergency situation (like Remdesivir), then some safety steps can be skipped. Human safe doses for these drugs have already been studied, making it easy to catapult off past research and take a lot of shortcuts to accelerating a trial for COVID-19.
Other cases in which drugs may have changed routes of administration from past use in humans will require an intermediate amount of work. It is best for sponsors to take advantage of CTAP to discuss with the FDA exactly what type of accelerations are appropriate for their drugs.
As of May 11th, the FDA has reported more than 130 active trials for therapeutic agents, with another 457 in pre-IND. The FDA also released two new guidances to help developers get ready for COVID-19 research. The first offers advice on how to effectively seek early guidance, and the processes for applying for it. The second guidance lays out considerations for clinical trial design. Though we cannot predict which (if any) of these will prove effective, or how long this crisis will last, we can be assured that scientists and regulators are working as fast as they can.
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