Among all the stakeholders involved, oncology societies can play a pivotal role to facilitate efficient clinical investigations
In the recent past, the number of oncology agents being developed was small enough that it could be managed by relatively few academic centres. Now, the explosion in innovative drug development has led to the introduction of a huge number of different types of agents, which have progressively more complex structures and act at increasingly specific molecular targets. This expansion and the move away from a one-size-fits-all approach to precision oncology comes with its own challenges for early-phase trials, such as the requirement for extensive pharmacokinetic and pharmacodynamic investigations, not least to demonstrate proof of concept that any new agent is acting at the designated target. The wide range of tumour molecular targets identified has given rise to more cancer subtypes, but often with smaller numbers of patients potentially able to benefit from each specific treatment and with increasingly complex patient selection approaches.
We need to find ways to expedite early clinical development and one way to achieve this is by close cooperation between the main stakeholders in the process, all of whom bring their own particular expertise.
We must acknowledge that the time for a new therapy to be approved is still unacceptably long. Oncology professionals, particularly those working in academia, are uniquely placed to understand where the real unmet treatment needs are and can help to effectively direct the development of new agents. Indeed, many academics take their expertise to the pharmaceutical industry for this very purpose. The pharmaceutical industry also brings together scientists across disciplines, such as computational chemists, immunologists, biologists and biotechnologists. Regulatory authorities, which are tasked with representing the public, are responsible for ensuring that the anticancer agents reaching the clinic are safe, effective and their production is sustainable. Finally, patients play an integral part in calling for innovative agents that will provide them with treatments that truly meet their needs. These stakeholders should work together to develop a less complex, more transparent process that makes best use of current funding opportunities, such as Europe’s Beating Cancer Plan, and accelerates clinical development in a more streamlined way. And it is here that we can introduce another important stakeholder – oncology societies. Oncology societies can play a key role in bringing together representatives from industry, academia, regulatory authorities and patient groups to facilitate the dialogue and exchange of information. The value of this is easily provided not only by international congresses, but also by smaller national and local meetings, in a coordinated approach, to drive early-phase development forward.