Complexity and cost of drug development are now beyond the knowledge and operational capacity of single organisations. Therefore, a tremendous deviation from the traditional path of drug discovery and new forms of multidisciplinary partnerships are needed. The European Organisation for Research and Treatment of Cancer (EORTC) proposes the use of collaborative molecular screening platforms (CMSPs) as a new approach to tackle this issue. In a paper published in the Nature Reviews Clinical Oncology, the EORTC researchers describe how CMSPs could help serve these needs.
Drug developers 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 research and development productivity. An accompanying EORTC news stresses the need for better ways to identify new candidate drugs and 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.
Collaborative Molecular Screening Platforms
The EORTC researchers argue in their paper that new forms of partnership, as well as an integrated model of cancer research are needed. The CMSPs offer a high quality integrated infrastructure for efficient screening of patients with cancer for specific molecular alterations.
Such identified alterations will define target populations for early trials with novel targeted agents. In their article, EORTC researchers foresee that 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.
According to Dr Denis Lacombe, EORTC Director and lead author of this paper, “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.”
As information-sharing platforms, the SMSPs enable researchers to learn from 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 lead to the achievement of personalised medicine.
This article; describing some of the challenges to advancing drug development and improving medical treatments and how these hurdles can be overcome, is very important, as current drug development procedures are far from optimal, as is exemplified by the late-stage failure of several drugs. The identification of new drugs urgently requires approaches based on a solid understanding of cancer biology, and that will support the design of robust confirmatory trials. The EORTC proposal has therefore arrived in a timely fashion.