Cancer Research UK Makes Clinical Trials Patient Data Available in Five Days Rather Than Six Weeks
 
 

Cancer Research UK Makes Clinical Trials Patient Data Available in Five Days Rather Than Six Weeks

Cancer Research UK is the world’s leading charity dedicated to beating cancer through research. Its work has resulted in a significant number of discoveries that have fundamentally changed the way cancer is prevented, diagnosed, and treated. The Drug Development Office works with UK academic centers and commercial partners on clinical trials for novel anticancer agents, such as abiraterone. The Drug Development Office sponsored early clinical trials for abiraterone, recently approved by the FDA for advanced prostate cancer, and it is currently investigating abiraterone as a treatment for breast cancer.

 
 

 
 

Challenges

A word from Cancer Research UK

  • “Oracle Health Sciences InForm gives us faster access to high quality data and facilitates real-time decision-making, which helps shorten trial delivery times, reduces costs, and enables us to maximize the number of patient trials we can carry out." – Joanna Walker, Head of Quality, Regulatory and Pharmacovigilence, Drug Development Office, Cancer Research UK

  • Speed up collection, cleaning, and analysis of patient data from early phase oncology trials, focused on safety data, pharmacokinetics, and modulation of target biomarkers
  • Ensure organization conducts clinical trials in compliance with current legislation; minimize design, build, and set-up times; and re-use standard study components to gain efficiencies

Solutions

  • Implemented Oracle Health Sciences InForm to replace paper-based data capture with electronic case report forms, which eliminated rekeying patient data, cut errors and print costs, and reduced data management staff needs by almost 40%
  • Used Oracle Health Sciences Central Designer to define and deploy components and workflows for each trial, according to industry-leading practice and in compliance with UK law
  • Conducted first electronic data capture trials on therapeutic agents, novel drug combinations and imaging agents used to determine tumor size
  • Leveraged InForm’s automated, standards-based processes, real-time data visibility, and query management functionality to address discrepancies early and make data available quickly
  • Expected decrease in average time from last patient visit to final validated trial data from 16 weeks to 5 to 10 days
  • Cut time to make trial data available for analysis of patients’ safety, pharmacodynamic, and pharmacokinetic responses from an average of four-six weeks to five days
  • Used Oracle Healthcare Central Designer to build a library of proven study templates and methods for re-use in future clinical trials
  • Used InForm’s software-as-a-service option—built, delivered, hosted, and supported by Oracle—for first five clinical studies and then used knowledge gained to bring solution back in-house for future studies