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FDA Issues Covid-19 Therapy Trials, Review Guidance

Syringes

(Pikist)

13 May 2020. The Food and Drug Administration issued new regulatory guidance on clinical trials and streamlined review processes for Covid-19 treatments. The documents cover therapies, and aim to provide drug and biologics developers with the agency’s criteria in advance to reduce the time for reviewing submissions, without compromising effectiveness or safety of their products.

FDA says as of 11 May, 144 clinical trials for Covid-19 therapies are underway and another 457 programs are in planning stages under its emergency program called the Coronavirus Treatment Acceleration Program. Those new treatments come as the number of cases in the U.S. on 12 May nears 1.4 million and deaths exceed 82,000.

The clinical trial guidance focuses on mid- and late-stage clinical studies, also known as phase 2 and 3 trials respectively. These trials often enroll hundreds or thousands of participants, and gauge the proposed treatment’s efficacy and safety among individuals with the targeted disease. Early-stage or phase 1 trials look mainly for safety issues and often recruit small numbers of healthy volunteers.

Under normal circumstances, mid- and late-stage trials can take months or years to complete, but under the Covid-19 emergency, FDA aims to accelerate the process. The document spells out factors it expects therapy developers to address including populations the drug aims to treat and participants to enroll, design of the trial, specific goals of the clinical study called endpoints, and time needed to judge effects of treatments and their durability. FDA’s guidance emphasizes the need for gold-standard randomized clinical trials testing proposed treatments against a placebo, but the agency will also consider more flexible designs, such as platform, adaptive, or decentralized trials.

While early-stage trials aim to establish a drug’s safety, later trials also measure safety factors. The guidance underscores special factors affecting the safety of many Covid-19 patients, such as co-morbidities and harmful interactions with drugs treating those other conditions. In addition, the document recommends statistical analysis methods, including measurements based on the total intent-to-treat populations that incorporate numbers of deceased patients.

The second document describes streamlined review processes for Covid-19 treatments to reduce the time needed by developers to get their therapies into clinical trials. In FDA parlance, this is known as the pre-IND or investigational new drug phase, where developers request the agency’s authorization to begin clinical trials.

For new Covid-19 treatments, FDA is asking developers to submit its request for a pre-IND meeting with agency staff and include its documentation for starting clinical trials. By consolidating these steps, FDA says it can provide faster feedback to developers, without affecting patient safety. In addition, the document spells out the data the agency needs to review these requests, for different types of drugs and biologics and administration methods.

The document also tells developers FDA prefers using the pre-IND process rather than an emergency use authorization or EUA, an often-used procedure during the pandemic. Products considered good EUA candidates, however, can still be considered later on.

“We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products,” says FDA commissioner Stephen Hahn in an agency statement, “and believe these new guidances will help innovators and researchers do just that.”

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