About Friends

Diagnostics Partnerships Portfolio

Diagnostic tests play a crucial role in supporting the development of oncology drugs and determining the best treatment options for cancer patients. It’s important that these tests are reliable and consistent across the industry.

Friends Diagnostics Harmonization Portfolio focuses on promoting alignment of these tests by generating evidence to understand their variability, ensuring that different testing methods provide accurate and consistent results for patients.

Real-World Evidence Portfolio

Real-world data and evidence have the potential to provide valuable insights into the real-world performance of cancer treatments and diagnostics, including characterizing use in a broader patient population. However, there is currently a lack of standardization in capturing, analyzing, and reporting these data. Additionally, traditional clinical trial designs and regulatory frameworks could be enhanced to better leverage insights from real-world data.

Friends’ Real-World Evidence Portfolio works to align best practices and frameworks for analyzing real-world data. By reaching alignment, stakeholders can use real-world data to support evidence generation in populations that are more representative of those using the treatment and inform treatment effectiveness and long-term safety for patients.

ctMoniTR Project

Circulating tumor DNA (ctDNA) is tumor DNA shed by cancer cells that can be detected through a blood test. This offers a quick and scientifically valid method for assessing treatment efficacy, including how changes in ctDNA on treatment could be linked to long-term outcomes such as overall survival.   

As new treatments rapidly evolve, the clinical trial process can struggle to keep pace. The Accelerated Approval pathway allows FDA to approve drugs based on earlier endpoints reasonably likely to predict clinical benefit and ctDNA holds promise to show that treatments are working sooner. However, it is important that analyses across multiple datasets support the use of ctDNA as an early endpoint before it can be used in regulatory decision-making.  

The Friends ctMoniTR project does just that by combining data from more than 3,000 patients to evaluate the ability for ctDNA to be a reliable early endpoint in cancer clinical trials. Together with our project partners, we’re working to establish ctDNA as an indicator of treatment response faster than if any single organization tried to do so alone.  

Digital Pathology Project

The evaluation of tissue biopsies is an important component of cancer diagnosis and treatment. Emerging technologies, such as computational and digital pathology that leverage artificial intelligence (AI) for biomarker assessment, are being developed with the goal of improving the accuracy, reproducibility, and efficiency of biomarker assessment. However, whether these AI-driven tools provide similar results to one another is unknown. This variability, along with the uncertainty in the regulatory path and evidence generation to support use of this emerging technology, poses challenges to its broader adoption.

Friends’ Digital PATH Project aims to assess the level of variability in digital pathology platforms that analyze HER2 in breast cancer using a common set of samples. Understanding the level of variability in outputs from different models that were established using AI can support alignment and inform the use of reference sets to evaluate performance, providing a foundational step forward in applying AI to improve patient outcomes in cancer care.