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FDA's Update Sparks Transformation for Clinical Trials


FDA's update sparks transformation for clinical trials

More companies are choosing clinical trials than ever! Because of this boom, the technology and methodologies are evolving to meet the demand. Modernization to a well-established scientific practice requires updates and oversight from the FDA.


In response, they released a draft guidance for enhancing pharmaceutical trials and medical products (although it does have implications for your wellness products). The guidance comes from the International Council for Harmonisation's (ICH) updated E6(R3) draft guideline. It aims to incorporate emerging tech and methodological advancements into the clinical trial process.


The implementation of Good Clinical Practices (GCPs) is crucial to ensure participant safety and maintain data integrity. Prior to the COVID-19 pandemic, clinical trials were regarded as costly, inefficient, and hindered by limited collaboration and underutilization of technology, data sources, and design innovations. However, the pandemic served as a catalyst for the development of new approaches.


What does this FDA update to clinical trials mean for your brand?

As the industry evolves and the FDA releases updates, it impacts the clinical trial process. Although this update is still a draft, let’s break down some of the ways these updates could potentially affect your brand.


1. Your study could be completed faster, with high data integrity

“These draft recommendations were developed to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve,” said M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy. “We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”

The revised draft recommendations have been designed to be applicable to a wide range of clinical trials, including those incorporating innovative design elements. These elements have the potential to enhance efficiency and reduce burdens, essentially moving your study along at a quicker pace.



man sleeping while using Oura Ring. Data dashboard displayed on a phone
source: Oura Ring

2. Data collection will be easier with the use of wearable technology

The updated GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors, like Oura Ring and Fitbit have the potential to enable agile data collection and facilitate patient recruitment, as stated by the FDA in their statement.


“A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” said FDA Commissioner Robert M. Califf, M.D. “These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”


"We are thrilled to witness the rapid advancement of technology in the clinical trial space. The FDA's draft guidance opens up exciting possibilities for wellness brands, allowing them to leverage emerging tech and methodologies to conduct more efficient and data-driven trials.
This development aligns perfectly with our mission at Citruslabs to empower brands to embrace innovation and drive meaningful results in the pursuit of participant safety and wellness. The future of clinical trials is bright, and we are excited to be at the forefront of this transformative journey," says Susanne Mitschke, CEO and co-founder of Citruslabs.


It's important to note that while this guidance is significant for the pharmaceutical industry, it does not exempt the food industry from its responsibility to provide reliable scientific evidence to support structure-function claims related to ingredients or products. Nutraceutical protocols and facilities are expected to adhere to many of the same principles outlined in this drug pharma guidance, including quality management systems, trial design, conduct, reporting, IRB/IEC approval, and record-keeping.




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