The Food and Drug Omnibus Reform Act of 2022 (FDORA) was signed into law, amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. It includes provisions that impact various aspects of the FDA-regulated industry. Some key provisions include reauthorizations of FDA programs, reporting requirements for approved biological products, improvements in rare disease treatment, the establishment of an Emerging Technology Program, creation of National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing and modernization of accelerated approval.
FDORA streamlined regulatory pathways for the medical device industry, enhanced advisory committee input, third-party review program evaluation, and aimed to improve device cybersecurity by manufacturing, which will help to mitigate potential vulnerabilities.
In terms of clinical trials, the Act emphasizes on diversity, requiring sponsors to consider diversity in pivotal studies and submit diversity action plans to the FDA. The FDA is mandated to issue guidance on diversity action plans, hold public workshops on clinical study diversity, and report on progress in increasing diversity. The Act also addresses decentralized clinical trials and the use of digital health technologies in clinical trials.
Decentralized clinical trials and the use of digital health technologies in clinical trials:
Decentralized clinical trials (DCTs) and the use of digital health technologies in clinical trials have gained significant attention and importance in recent years. DCTs refer to clinical studies in which some or all the study-related activities occur at a location separate from the investigator’s location. These trials leverage digital technologies to collect data remotely, improve participant recruitment, and enhance overall trial efficiency.
The Food and Drug Omnibus Reform Act of 2022 (FDORA) recognizes the evolving nature of clinical trials and includes provisions to advance the use of DCTs and digital health technologies. Section 3606 of FDORA requires the FDA to issue guidance on decentralized clinical trials, providing recommendations on various aspects such as:
- Selecting and validating technological platforms for data collection.
- Using electronic informed consent.
- Communicating with remote participants.
- Shipping investigational drugs and devices directly to participants.
- Evaluating data collected in a decentralized setting.
Furthermore, FDORA mandates the FDA to issue guidance on the use of digital health technologies in clinical trials. This guidance aims to improve recruitment and data collection by leveraging digital tools while ensuring compliance with data privacy and human subjects protection laws. It addresses topics such as acquiring electronic informed consent, validating digital health technology for use in trials, assessing and evaluating data collected through digital health technologies, and optimizing data submission formats.
The legislation also emphasizes the importance of diversity in clinical trials. Section 3601 of FDORA requires sponsors to consider diversity and submit diversity action plans to the FDA. This provision aims to increase the representation of underrepresented populations in clinical trials and enhance the generalizability of trial results to the broader patient population.
FDORA encourages the FDA to collaborate with foreign regulators to facilitate the international harmonization of regulations and the use of DCTs and digital health technologies. This collaboration aims to streamline the adoption and implementation of these innovative approaches across different jurisdictions, promoting efficiency and consistency in clinical trial practices.
Overall, the inclusion of provisions related to DCTs and digital health technologies in FDORA reflects the growing recognition of their potential to transform and improve the conduct of clinical trials. These advancements have the potential to enhance participant engagement, increase trial efficiency, and generate more robust and representative data for regulatory decision-making.
As a leading software and services company specializing in electronic Patient-Reported Outcomes (ePRO), Electronic Data Capture (EDC) and Site Clinical Trial System solutions, integrating digital recruitment strategies up to a validated EMR with multilingual, multizone, capabilities to support diversity programs. Integra IT is at the forefront of this revolution. Our innovative software empowers researchers, sponsors, and CROs to conduct hybrid clinical trials efficiently while ensuring compliance with FDORA guidelines, promoting diversity and inclusion.
How current tech tools can help:
Compliance with FDORA Guidelines
FDORA mandates the use of digital health technologies in clinical trials, and our site recruitment, CTMS and EMR, ePRO and EDC solutions are designed to meet these requirements. Our software ensures secure and compliant data collection, electronic informed consent, and participant engagement, all while adhering to the highest standards of data privacy and protection. By utilizing our FDA-compliant solutions, researchers can confidently navigate the regulatory landscape and streamline their trial processes.
Enhanced Participant Engagement
FDORA emphasizes the importance of participant engagement in clinical trials. First, our Site All-In-One Clinical Trial Solution empowers recruiters with a continuous digital presence, improving engagement, answering questions even before a clinical trial is announced, it also has a simple and guided workflow for researchers to work aligned towards patient experience and under approved guidelines including smart scheduling, enrollment activities, etc and feed patient history together with its Electronic Medical Record/eSource modules.
Our ePRO and EDC solutions offer user-friendly interfaces and intuitive workflows, ensuring a seamless experience for participants. Through mobile applications and web-based platforms, participants can easily report their outcomes, complete questionnaires, and provide feedback. By empowering participants to actively engage in the clinical trial process, our software enhances data quality and participant retention, leading to more robust and reliable results.
Real-Time Data Capture and Analysis
FDORA encourages the use of digital health technologies for real-time data capture and analysis. Our ePRO and EDC software enable researchers to collect data in real-time, eliminating the need for manual data entry and reducing the risk of errors. Our ePRO works even without an internet connection, allowing participants to report when they can or feel to and the app synchronizes once the internet connection is restored.
In conclusion, the Food and Drug Omnibus Reform Act of 2022 (FDORA) represents a significant milestone in the FDA-regulated industry, with the potential to transform regulatory processes, promote innovation, and improve public health outcomes.
While FDORA brings significant changes in the landscape of clinical trials, it presents numerous opportunities for the industry in terms of implementation and resource allocation. It is crucial for industry stakeholders to adapt and utilize the opportunities presented by FDORA to drive innovation, adopt clinical trial software technologies, and ensure compliance.
References:
Sections: 3602, 3603, and 3604 The Food and Drug Omnibus Reform Act of 2022 (FDORA)
