Drug developers are facing the perfect storm. They are confronted with major patent expiries, increased payer scrutiny, changing priorities, shifting business models, increased risk averseness, increased clinical trial costs, not to mention issues concerning R&D productivity. There needs to be a better way to identify new candidate drugs. There needs to be a new drug development pathway that is compatible with research aimed at understanding the biology of a cancer and simultaneously able to support the design and conduct of subsequent confirmatory trials, but building and maintaining such a drug development pathway is beyond the ability of individual organizations or companies.
It has been argued that new forms of partnership as well as an integrated model of cancer research are needed. Now, in a paper published in Nature Reviews Clinical Oncology, the EORTC describes how collaborative molecular screening platforms could help serve these needs.
Collaborative molecular screening platforms offer a high quality integrated infrastructure for efficient screening of patients with cancer for specific molecular alterations. These identified alterations will define target populations for early trials with novel targeted agents. Pharmaceutical industry partners would be in a position to propose candidate drugs for clinical trials which could be plugged into the platform. Patients fulfilling the inclusion criteria for one or more trials would be notified by their physician and given the option of participating.
Dr. Denis Lacombe, EORTC Director and lead author of this paper says, “Collaborative molecular screening platforms will offer patients efficient access to new therapeutic agents. Clinical research will be turned on its head. Instead of designing trials which must find patients for a particular drug, the question will become which drug should be given to a particular subset of patients with an identified molecular alteration.”
Collaborative molecular screening platforms are a winning proposition for all cancer drug development stakeholders. As information-sharing platforms they enable us to learn from our failures. They accommodate the integration of information from continuous risk assessments and pave the way for an adaptive licensing strategy. Importantly, they enhance the expertise of the constituent partners by combining their efforts within a cost-sharing model and could very well be the realization of personalized medicine.
For more information please contact: www.eortc.org/contact