Molecular-Targeted Treatment for Cancer Through Patient-Donated Data
A US comprehensive Cancer Centre has discovered that a biological data facility can accelerate recruitment, lower costs, minimise trial size and expedite the testing of medicines during drug development.
When choosing patients for phase II clinical trials, researchers at Moffitt Cancer Centre are one of the few who have created a facility that systematically collects and maintains biosamples, electronic medical records, a related analysis of molecular activity as well as other data from the patient population. These samples were donated by more than 96,000 patients as part of the organisation’s ‘Total Cancer Care’ Protocol and used to ascertain clinical trial participants based on their biological and molecular make-up.
Through conducting a ‘value of information’ study on the effectiveness of data warehousing in organising phase II clinical trials, these researchers found that patient recruitment was quicker and fewer participants were needed. The authors also discovered that the amount of information sourced was equal to the data that is received from trials with bigger sample of participants.
Chair of the Biomedical Informatics Department at Moffitt and the study’s lead author David Fenstermacher highlights the value of the ‘Total Cancer Care’ programme by saying, “Our study provides evidence that programs, such as the ‘Total Cancer Care’ Protocol, that follow patients and collect clinical data for storage in a common warehouse can reduce the number of patients needed for a clinical trial without compromising the results of the study.
Another positive impact of using the biorepository for clinical trial participation is that phase II trials that test new cancer treatments being developed by the pharmaceutical industry move more quickly and cost less.”
Researchers of this study have added that the need to create patient bio repositories is driven by the recognition of genetic signatures and the effort to discover biomarkers for diseases. The design of clinical trials will gradually improve as personalised medicine uncovers these types of molecular-related innovations.
Associate member of Moffitt’s ‘Health Outcomes and Behaviour Programme’ Benjamin M. Craig expands on the need for this type of innovation for research, “By taking a systems approach, biomarker and genetic profile information not only enables personalized medicine, but also promotes comparative effectiveness research. The contribution of a data warehouse that integrates clinical, biospecimen and molecular data for conducting clinical trials is essential for making good decisions about resource allocation.”
More importantly, an effective assessment of these molecular-based therapies for tumours will be a major part of stratified clinical trials as they become shorter, smaller, cheaper and more personalised. The creation of this type of targeted treatment will depend on the use of biospecimen, clinical and molecular data gleaned from everyday care.
Fenstermacher concludes, “The knowledge gained from our study and other studies under way at Moffitt are providing the foundation for creating the next generation of data management infrastructure to support personalized medicine. As these resources mature, data assessment strategies, such as ‘value of information’ studies, will be imperative to understand how data can be used to enhance patient care and improve treatment outcomes through evidence-based guidelines.”