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Draft Guidance Released by USFDA to conduct FIH clinical trials for Cancer Drug Developers

A draft guidance to conduct first in human (FIH) clinical trials for cancer drugs has been released by USFDA which will help sponsors in designing clinical trials to speed up the development of cancer drugs through multiple expansion cohort study designs.

The draft guidance provides insight into the characteristics of drugs and biologics appropriately suited for such an expedited plan. It also includes information as what needs to be there in Investigational New Drug Applications submissions for such trials, when to interact with FDA and how to safeguard patients enrolled in FIH expansion cohort studies.

According to FDA, "FIH multiple expansion cohort trials are defined as trials with a single protocol with an initial dose-escalation phase that also contains three or more additional patient cohorts with cohort-specific objectives and intended to expedite development by proceeding from initial determination of a potentially effective dose to individual cohorts that have trial objectives typical of phase II trials. These trials pose challenges and risks such as exposing patients across multiple, simultaneously accruing cohorts to potentially suboptimal or toxic doses of an investigational drug or exposing more patients than required to achieve certain objectives. To ensure such studies are worth the added risk, the patient population should be limited to patients with serious diseases for which no curative therapies are available."

According to the draft guidance objectives of such trials would include

1) assessment of anti-tumor activity in a disease specific setting
2) assessment of a reasonably safe dose in specific populations (e.g. pediatric or elderly patients or patients with organ impairment)
3) evaluation of alternative doses or schedules
4) establishment of dose and schedule for the investigational drug administered with another oncology drug
5) evaluation of the predictive value of a potential biomarker

According to FDA Commissioner Scott Gottlieb,” The draft guidance discusses ways through which sponsors can club together the traditional three phases of trials into one continuous trial called as an expansion cohort trial which can lead to efficient drug development reducing the development cost and time which otherwise is spent waiting in between the start and end phases of traditional trials.