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Navigating the FDA Pilot Program in Oncology Drugs with In Vitro Diagnostic Tests: The Role of Real-World Data

26 July, 2023

The landscape of oncology research and development is constantly evolving, with breakthroughs in both diagnostic (Dx) and therapeutic (Rx) advancements.  One recent development that holds tremendous potential to revolutionize concurrent Dx and Rx development is the new Oncology Drug Products with In Vitro Diagnostic Tests pilot program introduced by the U.S. Food and Drug Administration (FDA).  This new pilot program requires testing performance criteria to be published based on the collection of data from labs using FDA provided templates. Our Chief Precision Medicine Officer, Susanne Munksted, in her thought-provoking blog post, delved into the various questions and potential challenges that must be addressed within the pilot program, particularly in the context of drug manufacturers seeking to bring their products to market.

Today, we aim to shed light on the critical role real-world data (RWD) plays for drug manufacturers considering participation in the pilot program and the subsequent commercialization of their assets, especially in the established biomarker setting (not novel). We’ll focus on specific RWD elements that we believe will play an important role for manufacturers navigating the pilot program.

Ease of Local Site Dx Technical Data Collection: Diaceutics understands the complexity of collecting technical specifications from multiple laboratories with our over ten years’ experience delivering our Lab Segmentation solution. Diaceutics Lab Segmentation includes essential metrics such as sensitivity, specificity, and limit of detection. Utilizing such a database may allow pharmaceutical manufacturers to verify the data with laboratories rather than going through the arduous task of collecting and processing the data into an FDA ready format, particularly important where local site testing is being used for clinical trial enrollment.

Site Selection Criteria: Selecting the right clinical trial sites is pivotal for success within the pilot program. By leveraging technical data, drug manufacturers can identify more sites that exhibit comparable testing characteristics. This approach minimizes the risk of patients being excluded from the final clinical trial analysis due to testing criteria thresholds needing to be met. Ultimately, this ensures that a representative patient population is included, leading to more robust and reliable results.

Mapping Relationships between Physicians and Labs: Understanding the intricate relationships between clinical trial sites, physicians, and labs is critical for efficient patient recruitment under the pilot program. By analyzing send-out data and testing criteria, drug manufacturers gain valuable insights into where clinical trial sites and physicians send their samples. This information greatly aids in identifying potential recruitment channels and streamlining patient enrollment.

The Vital Role of RWD: As the FDA pilot program in oncology takes shape, the importance of real-world data cannot be overstated. RWD will serve as a vital tool for drug manufacturers, helping them navigate the evolving regulatory landscape and make data-driven decisions. By leveraging RWD, manufacturers can optimize the development process, enhance patient outcomes, and contribute to the advancement of cancer care.

Conclusion: The FDA pilot program in oncology presents a groundbreaking opportunity for drug manufacturers to usher in a new era of concurrent Dx and Rx development. As a data vendor in the life sciences industry, we emphasize the significance of leveraging RWD to address critical considerations such as local site Dx technical data collection, site selection criteria, and mapping relationships between physicians and labs. By embracing RWD, manufacturers can pave the way for innovative therapies, improved patient care, and ultimately, a paradigm shift in the fight against cancer.

Read our Chief Precision Medicine Officer, Susanne Munksted's opinion on the pilot and the consequences for pharmaceutical companies here:

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About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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