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Clinical Insider

US FDA should clarify rules on investigator statements

Posted by on 20 February 2024
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Clarification of US FDA rules on clinical investigator statements would help more cancer patients take part in drug research according to a new study.

The study – published in the journal Cancer – is described as a “call to action to advance patient-focused and decentralized clinical trials” by the authors, who say confusion about Form 1572 submissions is a major participation hurdle.

“The purpose of FDA Form 1572 is to provide trial sponsors with information about investigator and site qualifications and inform the investigator of their responsibilities and commitment to follow pertinent federal regulations.

“Current practice, however, tends to go beyond these regulatory requirements, causing undue administrative burden and barriers to local patient and provider trial participation,” they write.

The authors argue conservative sponsor and contract research organization (CRO) interpretations of the requirements have the form into a data-collection tool for cataloguing medical providers and ancillary facilities and created time-consuming paperwork.

“These issues become exponentially burdensome with respect to protocol amendments and are compounded when local providers who deliver routine care to research participants are required to be listed on the form.

“The cumulative regulatory and administrative burdens hinder the primary research site's ability to facilitate local patient and provider participation and may discourage rural and local clinics/hospitals, in particular, from participating in research,” they write.


The authors call on the US Food and Drug Administration (FDA) to clarify Form 1572 requirements, and in particular provide a definition of the term “direct and significant contribution” as it pertains to healthcare professionals involved in drug studies.

“There is lack of clarity around whether a nurse administering investigational treatment as part of a patient's care on a clinical trial is deemed as providing direct and significant contribution to the data. It is unclear whether contribution to the data is applicable to any generation of data.

“There are additional nuances, which add to confusion and inconsistencies, such as not requiring emergency room personnel to be included on the form if a patient has an emergency room visits while on study.”

“The definition of contribution should be clarified. Otherwise, there is a slippery slope of personnel additions to Form 1572 with an overly broad interpretation or generally undefined use of these key words: direct, significant, contribution, data, and engaged,” they say.


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