Clinical Trials Model
The current view of translating scientific discoveries into clinical therapies imposes discrete roles on academia and industry. Academia generates the discovery; industry develops it into a product. Too frequently the clinic door is the line of demarcation between these separate domains.
The clinical trials discovery model employed by the CVC differs significantly from this traditional paradigm, and is the result of the pioneering academic partnership between CRI and LICR.
Opening up the clinic door…
First, laboratory and clinical research are closely integrated during early-phase CVC clinical studies, allowing the novel discoveries made during these trials to be incorporated into future vaccine strategies.
Scientific, rather than profit-driven, control of clinical trials…
The CVC’s commitment to early-phase clinical trials includes: producing clinical- grade study agents in LICR’s own biological production facilities, or obtaining them through collaborative agreements with commercial partners, preparing and submitting regulatory documentation, and ensuring that the trials are conducted under internationally recognized and approved safety, ethical, and scientific standards.
Coordinated, systematic, standard-monitored, parallel…
Trials are conducted at multiple clinical centers, each supported by a laboratory, and each applying standardized techniques for immunological monitoring and clinical evaluation. This model allows an efficient and rapid comparison of many vaccine variables through their simultaneous and equivalent evaluation at different centers.
LICR and CRI believe that this distinctive model, unique in academia and industry, is essential to achieve the ultimate aim of creating effective human cancer vaccines.