FDA Officials Shower Investigators with Praise—And a Few Warnings

FDA Headquarters

Leading U.S. Food and Drug Administration (FDA) officials hailed clinical study investigators as some of the unsung heroes of the clinical trial ecosystem during an agency training course last week in College Park, Md. However, regulators also reminded anyone contemplating leading studies to understand just how difficult the principal investigator (PI) role can be.

“It’s a huge job,” said Cynthia F. Kleppinger, MD, with the FDA’s Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research (CDER), told attendees of the CDER Small Business and Industry Assistance FDA Clinical Investigator Training Course. Stressing how much she admired the people who took on the important work of leading clinical trials, she acknowledged it’s not a job for the faint of heart, or those adverse to paperwork. “It can be a frustrating” job, and “if you don’t like doing paperwork…run as fast as you can to the door,” she half-jokingly said.

Heavy hangs the head that wears the investigator crown, Kleppinger said. “The clinical investigator is in charge and held accountable” for trial conduct, she noted. FDA regulations permit sponsors to transfer their responsibilities to contract research organizations (CROs), but they don’t allow clinical investigators to transfer their general responsibilities to CROs or site management organizations, sub-investigators, or study staff, she added.

There’s also a bit of semantics at play, Kleppinger said. For example, while a PI can view another person as a co-investigator for the study site’s operational purposes, there is no such thing from a regulatory perspective. “Each co-investigator is fully responsible for fulfilling all of the obligations of an investigator; each much sign a separate Form FDA 1572,” she explained.

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Also, “we don’t use the term PI,” Kleppinger said. Instead, the agency uses the basic term “investigator” to recognize the “individual who actually conducts a clinical investigation; i.e., under whose immediate direction the drug is dispensed to a subject.” In the event an investigation is conducted by a team of individuals, the investigator is the designated responsible leader of the team, Kleppinger said.

Delegation is a tricky area for investigators, too. While the FDA has no specific regulation concerning delegation of many duties, FDA guidance states “the investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task.”

Further, while investigators don’t necessarily have to be medical doctors, they must have one on the team as a sub-investigator to perform study functions that require appropriate levels of medial expertise, such as assessing adverse events and making other medical decisions.

Author: Michael Causey