Q&A: The need for speed
Professor Udai Banerji, Deputy Director of the Drug Development Unit at the ICR and The Royal Marsden, talks about how smarter early-stage trials could help bring new drugs to patients sooner
What is the process for testing cancer drugs?
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Bringing innovative drugs and treatments to cancer patients is a lengthy and expensive process. On average, it takes 10-12 years to bring a new cancer drug to market, as it needs to be tested thoroughly in clinical trials. These trials comprise several phases: to first test for safety in a small number of patients (Phase I), and then to find out whether they are effective and better than the current standard treatment in larger groups of patients (Phases II and III).
How has that process changed over time?
Over the past decade, there has been an important shift in the emphasis of early-phase studies, where the effectiveness of drugs is being established much earlier as part of Phase I and Phase II studies.
Where this happens successfully, we have seen examples of drugs being licensed for use in Phase I or Phase II studies. This has enabled drugs to be licensed for treatment up to five years earlier than they would have been in previous years.
"We’re aiming to speed up the process so we can get the most promising treatments to patients faster."
Can you tell us about your approach to running trials?
In the Drug Development Unit at the ICR and The Royal Marsden, my team is looking for ways to run smarter trials to get more information from the earliest stages of testing. We’re aiming to speed up the process so we can get the most promising treatments to patients faster.
We use this to answer important questions at the early stages of testing related to toxicity (the side effects of the drug); pharmacokinetics (what the body does to the drug and how is it taken up, distributed or broken down by the body); and pharmacodynamics (what the drug does to the body – for example, how does the drug affect certain proteins or other building blocks of cancer like RNA or DNA?).
Are there any other benefits to early trials?
In addition, we identify and test biomarkers of response to help us understand which subsets of a patient group are likely to respond best to a treatment. This helps us to demonstrate impact earlier on and speeds up our ability to progress a drug through clinical development. Most importantly, it also allows us to develop personalised approaches to treatment that benefit patients. We also study how tumours develop resistance to cancer drugs, and important ways of overcoming this.
What is special about working in the Drug Development Unit?
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We are very privileged to work in a multidisciplinary environment. We conduct a lot of the tests forthe clinical trials ourselves in adjoining laboratories in the NIHR Centre for Molecular Pathology. And we have close working relationships with scientists who are specialists in biology, chemistry, physics, mathematics and statistics at the ICR and are co-located on our campus. Also, we are very lucky to work with clinical teams at The Royal Marsden that include world-leading experts in the treatment of individual cancer types.
This cross-pollination of ideas and specialities is the perfect environment for groundbreaking research that will change the lives of cancer patients.