Rethinking the 1572 Form: Catherine Gregor’s Response to CDER’s Call for Comments

In response to the FDA Center for Drug Evaluation and Research (CDER)’s recent call for comments on enhancing the adoption of innovative clinical trial approaches, there is a significant opportunity to discuss the modernization of FDA Form 1572, particularly in light of decentralized clinical trials (DCTs). The integration of new technologies and methodologies in clinical trials, as outlined by the CDER, highlights the need for updates to regulatory forms and practices to better support innovation.

The proposed reforms for FDA Form 1572 are designed to reduce the complexity and administrative burden that currently hampers clinical research innovation. By reducing non-essential fields and integrating smart, adaptive form technologies, we can ensure that the form better accommodates the varying needs of different types of clinical trials, including DCTs.

The integration of a system where Form 1572 can automatically verify information from other regulatory documents will minimize redundancy and errors, fostering a smoother regulatory process. Moreover, refining definitions, such as those for “Sub-Investigator,” to reflect roles specific to innovative trial approaches like DCTs, will clear up ambiguities that may hinder the implementation of new trial designs.

In response to the challenges highlighted by CDER, particularly for DCTs, it is crucial to adapt the language and structure of Form 1572. This involves explicitly defining “Sub-Investigator” roles to include only those individuals who perform specific protocol tasks distinct from routine care. Additionally, revising the term “contribution to data” to “interpretation of data and/or clinical results” will more accurately reflect the contributions that warrant inclusion on the form, thus ensuring clarity and compliance in DCTs.

Implementing an online platform for Form 1572 submissions that offers real-time updates and assistance could dramatically improve the efficiency of form completion and submission. This platform would support the use of electronic signatures and provide AI-driven tools like chatbots to help users navigate the form accurately and efficiently, aligning with CDER’s emphasis on integrating digital health technologies (DHTs) and real-world evidence (RWE) in drug development.

The ongoing efforts by CDER to foster innovation in clinical trial design and conduct are commendable. As we consider the barriers to adopting innovative approaches, it’s clear that regulatory documentation, including FDA Form 1572, plays a pivotal role. The suggested reforms not only aim to reduce the bureaucratic burden on researchers but also enhance the reliability and efficiency of data collection in clinical trials. This is particularly pertinent as we move towards more complex, innovative trial designs and decentralized methodologies that require a flexible and responsive regulatory framework.

As the public workshop approaches and CDER continues to gather insights, the integration of these reforms will be vital for advancing the objectives of innovative clinical trial methodologies. It is an opportune time for stakeholders across the clinical research enterprise to engage in this dialogue and contribute to shaping a regulatory environment that truly supports innovation.

Check out the Florence Library of FDA Guidance for Electronic Document Management for more information to help you understand and apply the FDA’s guidance on eSource and eRegulatory.