Challenges in Oncology: From clinical trials to introducing new drugs to the clinic
Interview with Prof. Maureen Trudeau
The process of introducing a new drug into the clinic can be a complex process, from the perspective of clinical trial design and implementation, drug approval and reimbursement. The realization that clinical trial design needs to evolve, in order to more effectively transition drugs from promising candidates to clinical entities and to reject drugs that do not demonstrate clinical efficacy, has been an important recent development. In this era of personalized/ stratified medicine, the co-development of new anti-cancer agents, in conjunction with predictive biomarkers/companion diagnostics, is increasingly relevant. Biomarker-driven clinical trials permit identification of the population most likely to respond to the drug, thereby minimising unnecessary toxicity and cost and potentially accelerating patient benefit. While the current and future potential of targeted therapy is compelling, it must also be acknowledged that in the present economic climate, there is a critical need for consideration of cost-effectiveness, both in the trial setting and when the drug or therapeutic intervention is introduced as a standard of care. Maximising accrual to cancer clinical trials also needs to be prioritised, particularly among minority groups. Once the drug or therapeutic approach has been approved, the issue of cost remains a challenging one, with significant global variation in the reimbursement of publically funded cancer drugs. Highlighting these issues encourages the oncology community to develop innovative solutions, thus ensuring that the cancer patient has improved access to new drugs both on clinical trials and ultimately in the clinic.